Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-15 @ 2:08 AM
Study NCT ID:
NCT03038620
Status:
COMPLETED
Last Update Posted:
2021-11-19
First Post:
2017-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Liraglutide 3.0 on Body Fat Distribution
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'C564245', 'term': 'Platelet Glycoprotein IV Deficiency'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'parag.joshi@utsouthwestern.edu', 'phone': '2146458000', 'title': 'Dr. Parag Joshi', 'organization': 'UT Southwestern Medical Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Results reported according to updated statistical analysis plan published 7/28/2020 on CT.gov website. The updated 7/28/2020 analysis plan accounted for changes in data collection (blood biomarkers) during COVID-19 pandemic and was submitted and published prior to study completion and prior to study un-blinding with updated terminology for study endpoints compared to original protocol.'}}, 'adverseEventsModule': {'timeFrame': 'For the entire duration of the study: 40 weeks.', 'description': 'Adverse events collected at each study visit. GI side effects captured and reported in summary form.', 'eventGroups': [{'id': 'EG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 53, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 34, 'seriousNumAtRisk': 93, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'GI related', 'notes': 'Constipation, nausea/vomiting, upset stomach, diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 43, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Tract infection', 'notes': 'Upper Respiratory Infection (URI) or pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.49', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '14.6'}, {'value': '1.63', 'groupId': 'OG001', 'lowerLimit': '-1.62', 'upperLimit': '4.88'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint as a percent of the baseline.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.', 'unitOfMeasure': 'percentage of reduction in VAT', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed study endpoint assessment (interpretable MRI at baseline and at study end).'}, {'type': 'SECONDARY', 'title': 'Absolute Reduction in Visceral Adipose Tissue Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Reduction in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.59', 'spread': '4.80', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '4.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in body weight after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images.'}, {'type': 'SECONDARY', 'title': 'Absolute Reduction in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.75', 'spread': '5.35', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '4.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in body weight after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Reduction in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.90', 'spread': '6.43', 'groupId': 'OG000'}, {'value': '4.16', 'spread': '6.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images.'}, {'type': 'SECONDARY', 'title': 'Absolute Reduction in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '6.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Reduction in Total Body Adipose Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.59', 'spread': '7.15', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '7.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in total body adipose tissue (fat) mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images.'}, {'type': 'SECONDARY', 'title': 'Absolute Reduction in Total Body Adipose Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.76', 'spread': '2.87', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '2.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in total body adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.87', 'spread': '8.23', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '8.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images.'}, {'type': 'SECONDARY', 'title': 'Absolute Reduction in Abdominal Subcutaneous Adipose Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.52', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '1.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.95', 'spread': '7.61', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '8.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images.'}, {'type': 'SECONDARY', 'title': 'Absolute Reduction in Lower Body Subcutaneous Adipose Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.51', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '1.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Reduction in Liver Fat Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.37', 'spread': '61.43', 'groupId': 'OG000'}, {'value': '-20.63', 'spread': '104.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images.'}, {'type': 'SECONDARY', 'title': 'Absolute Reduction in Liver Fat Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.35', 'spread': '5.35', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '3.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.', 'unitOfMeasure': 'percentage of liver fat', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images are reported here.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Reduction in Total Body Lean Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.47', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '3.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images are reported here.'}, {'type': 'SECONDARY', 'title': 'Absolute Reduction in Total Body Lean Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images are reported here.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Reduction in Total Thigh Muscle Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.48', 'spread': '3.55', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '3.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images are reported here.'}, {'type': 'SECONDARY', 'title': 'Absolute Reduction in Total Thigh Muscle Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.35', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images are reported here.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.81', 'spread': '6.51', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '6.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,40 weeks', 'description': 'The effect on relative percent reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower risk for metabolic disease.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images are reported here.'}, {'type': 'SECONDARY', 'title': 'Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.23', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,40 weeks', 'description': 'The effect on absolute reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower risk for metabolic disease', 'unitOfMeasure': 'percentage of fat infiltration', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who completed baseline and endpoint MRI with interpretable images are reported here.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in VAT/SAT Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in Visceral adipose tissue/subcutaneous adipose tissue (VAT/SAT) ratio measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nThis is the ratio of visceral adipose tissue to subcutaneous adipose tissue and it is thought that lower values (relatively less visceral adipose tissue) are better.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Fat/Fat-free Mass Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.23', 'spread': '7.25', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '7.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute change from baseline in total fat/fat-free mass ratio measured by MRI after 40 weeks on treatment versus placebo.\n\nThis is a ratio of fat to lean mass and it is believed that lower values (less fat relative to lean mass) is better.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relative Percent Change in Fasting Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.62', 'spread': '10.77', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '13.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The relative percent change in fasting blood glucose from baseline to study end point as a percent of baseline by treatment group.\n\nNegative values reflect a reduction. This is a blood based biomarker for diabetes in which normal levels are desirable (70-100 mg/dL).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Change in Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.58', 'spread': '70.69', 'groupId': 'OG000'}, {'value': '7.73', 'spread': '58.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The relative percent change in insulin from baseline to study end point as a percent of baseline by treatment group.\n\nPositive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.\n\nThis is a blood based biomarker in which lower fasting levels are desirable.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Change in HOMA-IR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.35', 'spread': '71.44', 'groupId': 'OG000'}, {'value': '11.85', 'spread': '69.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The relative percent change in HOMA-IR from baseline to study end point as a percent of baseline by treatment group.\n\nPositive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.\n\nThe relative percent change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Change in C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.91', 'spread': '32.75', 'groupId': 'OG000'}, {'value': '19.02', 'spread': '76.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The relative percent change in biomarker of inflammation: C-reactive protein (CRP) from baseline to study end point as a percent of baseline by treatment group.\n\nNegative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.\n\nThis is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Change in Triglyceride/HDL-C Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.10', 'spread': '30.23', 'groupId': 'OG000'}, {'value': '-2.18', 'spread': '28.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The relative percent change in triglyceride/HDL-C ratio from baseline to study end point as a percent of baseline by treatment group.\n\nNegative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.\n\nLower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.'}, {'type': 'SECONDARY', 'title': 'Relative Percent Change in Nt-proBNP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.10', 'spread': '78.5', 'groupId': 'OG000'}, {'value': '20.47', 'spread': '79.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The relative percent change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point as a percent of baseline by treatment group.\n\nNegative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.\n\nNT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Fasting Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.49', 'spread': '12.41', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '12.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,40 weeks', 'description': 'The change in fasting blood glucose from baseline to study end point by treatment group.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'spread': '9.67', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '12.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The absolute change in insulin from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.', 'unitOfMeasure': 'mIU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in HOMA-IR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '3.15', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '5.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The absolute change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1. Collection was impacted by COVID-19 and changes to study visits.', 'unitOfMeasure': 'Molar units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.18', 'spread': '3.37', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': '6.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The change in Markers of inflammation: C-reactive protein (CRP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.\n\nThis is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Triglyceride/HDL-C Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The change in triglyceride/HDL-C ratio from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.\n\nLower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Nt-proBNP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.10', 'spread': '48.82', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '41.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.\n\nNT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.84', 'spread': '12.95', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '11.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The change in heart rate/pulse from baseline to study endpoint visit by treatment group.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.84', 'spread': '17.98', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '16.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The change in systolic blood pressure from baseline to study endpoint visit by treatment group.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'On-treatment Time, Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '36.1', 'spread': '8.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'weeks', 'description': 'The mean duration of treatment during study follow-up.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Uninterpretable Outcome (Imaging)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nLiraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.\n\nPlacebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.6', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '50.9', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Adipose tissue', 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '40.9', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '40.2', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Liters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Visceral Adipose Tissue', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '4.5', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '4.5', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Liters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Abdominal Adipose Tissue', 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '16.2', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '15.8', 'spread': '4.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Liters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lower Body Adipose Tissue', 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '15.6', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '15.1', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'MRI based quantification of adipose tissue from the lower body.', 'unitOfMeasure': 'Liters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Liver Fat', 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '6.1', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '6.9', 'spread': '7.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of fat', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Body Lean Tissue', 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '21.5', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '21.5', 'spread': '3.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Liters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Blood Glucose', 'classes': [{'categories': [{'measurements': [{'value': '100.6', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '99.1', 'spread': '14.4', 'groupId': 'BG001'}, {'value': '100', 'spread': '13.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Insulin', 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '18.0', 'spread': '17.0', 'groupId': 'BG001'}, {'value': '17.0', 'spread': '13.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mIU/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides (mg/dL)', 'classes': [{'categories': [{'measurements': [{'value': '109.4', 'spread': '49.7', 'groupId': 'BG000'}, {'value': '118.3', 'spread': '50.6', 'groupId': 'BG001'}, {'value': '113.2', 'spread': '50.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'C-reactive Protein (mg/L)', 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '7.8', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '7.9', 'spread': '5.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (pg/mL)', 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '44.1', 'groupId': 'BG000'}, {'value': '63.2', 'spread': '44.7', 'groupId': 'BG001'}, {'value': '61.1', 'spread': '44.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Participants with Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with Hyperlipidemia', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with Prediabetes', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Systolic blood pressure (mmHg)', 'classes': [{'categories': [{'measurements': [{'value': '130.3', 'spread': '14.9', 'groupId': 'BG000'}, {'value': '125.8', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '128.4', 'spread': '14.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure (mmHg)', 'classes': [{'categories': [{'measurements': [{'value': '80.9', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '78.5', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '79.8', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '101.0', 'spread': '17.9', 'groupId': 'BG000'}, {'value': '102.3', 'spread': '17.9', 'groupId': 'BG001'}, {'value': '101.5', 'spread': '17.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height (m)', 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '1.6', 'spread': '0.1', 'groupId': 'BG001'}, {'value': '1.6', 'spread': '0.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '37.2', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '37.6', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist Circumference (cm)', 'classes': [{'categories': [{'measurements': [{'value': '105.5', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '104.8', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '105.2', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline kcal/day', 'classes': [{'categories': [{'measurements': [{'value': '2177', 'spread': '195', 'groupId': 'BG000'}, {'value': '2196', 'spread': '189', 'groupId': 'BG001'}, {'value': '2185', 'spread': '192', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kcal/day', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Participants analyzed if they completed an endpoint assessment and had interpretable imaging data.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-24', 'size': 1420277, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-15T14:59', 'hasProtocol': True}, {'date': '2020-07-28', 'size': 220260, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-15T15:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 235}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2017-01-30', 'resultsFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2017-01-30', 'lastUpdatePostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-20', 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'On-treatment Time, Weeks', 'timeFrame': 'weeks', 'description': 'The mean duration of treatment during study follow-up.'}], 'primaryOutcomes': [{'measure': 'Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint as a percent of the baseline.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.'}], 'secondaryOutcomes': [{'measure': 'Absolute Reduction in Visceral Adipose Tissue Volume', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.'}, {'measure': 'Relative Percent Reduction in Body Weight', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in body weight after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.'}, {'measure': 'Absolute Reduction in Body Weight', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in body weight after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.'}, {'measure': 'Relative Percent Reduction in Waist Circumference', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.'}, {'measure': 'Absolute Reduction in Waist Circumference', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in waist circumference after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.'}, {'measure': 'Relative Percent Reduction in Total Body Adipose Tissue', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in total body adipose tissue (fat) mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.'}, {'measure': 'Absolute Reduction in Total Body Adipose Tissue', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in total body adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.'}, {'measure': 'Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.'}, {'measure': 'Absolute Reduction in Abdominal Subcutaneous Adipose Tissue', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.'}, {'measure': 'Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.'}, {'measure': 'Absolute Reduction in Lower Body Subcutaneous Adipose Tissue', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.'}, {'measure': 'Relative Percent Reduction in Liver Fat Percent', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.'}, {'measure': 'Absolute Reduction in Liver Fat Percent', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower cardiovascular risk.'}, {'measure': 'Relative Percent Reduction in Total Body Lean Volume', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.'}, {'measure': 'Absolute Reduction in Total Body Lean Volume', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.'}, {'measure': 'Relative Percent Reduction in Total Thigh Muscle Volume', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on relative percent reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.'}, {'measure': 'Absolute Reduction in Total Thigh Muscle Volume', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.'}, {'measure': 'Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent', 'timeFrame': 'Baseline,40 weeks', 'description': 'The effect on relative percent reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower risk for metabolic disease.'}, {'measure': 'Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent', 'timeFrame': 'Baseline,40 weeks', 'description': 'The effect on absolute reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint.\n\nReduction in this variable is believed to be associated with lower risk for metabolic disease'}, {'measure': 'Change From Baseline in VAT/SAT Ratio', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute reduction from baseline in Visceral adipose tissue/subcutaneous adipose tissue (VAT/SAT) ratio measured by MRI after 40 weeks on treatment versus placebo.\n\nPositive numbers reflect the reduction in the value from baseline to study endpoint.\n\nThis is the ratio of visceral adipose tissue to subcutaneous adipose tissue and it is thought that lower values (relatively less visceral adipose tissue) are better.'}, {'measure': 'Change From Baseline in Total Fat/Fat-free Mass Ratio', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The effect on absolute change from baseline in total fat/fat-free mass ratio measured by MRI after 40 weeks on treatment versus placebo.\n\nThis is a ratio of fat to lean mass and it is believed that lower values (less fat relative to lean mass) is better.'}, {'measure': 'Relative Percent Change in Fasting Blood Glucose', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The relative percent change in fasting blood glucose from baseline to study end point as a percent of baseline by treatment group.\n\nNegative values reflect a reduction. This is a blood based biomarker for diabetes in which normal levels are desirable (70-100 mg/dL).'}, {'measure': 'Relative Percent Change in Insulin', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The relative percent change in insulin from baseline to study end point as a percent of baseline by treatment group.\n\nPositive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.\n\nThis is a blood based biomarker in which lower fasting levels are desirable.'}, {'measure': 'Relative Percent Change in HOMA-IR', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The relative percent change in HOMA-IR from baseline to study end point as a percent of baseline by treatment group.\n\nPositive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.\n\nThe relative percent change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1.'}, {'measure': 'Relative Percent Change in C-reactive Protein', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The relative percent change in biomarker of inflammation: C-reactive protein (CRP) from baseline to study end point as a percent of baseline by treatment group.\n\nNegative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.\n\nThis is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.'}, {'measure': 'Relative Percent Change in Triglyceride/HDL-C Ratio', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The relative percent change in triglyceride/HDL-C ratio from baseline to study end point as a percent of baseline by treatment group.\n\nNegative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.\n\nLower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.'}, {'measure': 'Relative Percent Change in Nt-proBNP', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The relative percent change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point as a percent of baseline by treatment group.\n\nNegative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.\n\nNT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.'}, {'measure': 'Absolute Change in Fasting Blood Glucose', 'timeFrame': 'Baseline,40 weeks', 'description': 'The change in fasting blood glucose from baseline to study end point by treatment group.'}, {'measure': 'Absolute Change in Insulin', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The absolute change in insulin from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.'}, {'measure': 'Absolute Change in HOMA-IR', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The absolute change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1. Collection was impacted by COVID-19 and changes to study visits.'}, {'measure': 'Absolute Change in CRP', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The change in Markers of inflammation: C-reactive protein (CRP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.\n\nThis is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.'}, {'measure': 'Absolute Change in Triglyceride/HDL-C Ratio', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The change in triglyceride/HDL-C ratio from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.\n\nLower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.'}, {'measure': 'Absolute Change in Nt-proBNP', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.\n\nNT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.'}, {'measure': 'Change From Baseline in Heart Rate', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The change in heart rate/pulse from baseline to study endpoint visit by treatment group.'}, {'measure': 'Change From Baseline in Blood Pressure', 'timeFrame': 'Baseline, 40 weeks', 'description': 'The change in systolic blood pressure from baseline to study endpoint visit by treatment group.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Visceral', 'Cardiovascular Disease', 'Fat'], 'conditions': ['Obesity, Visceral', 'Cardiovascular Diseases', 'Fat Disorder']}, 'referencesModule': {'references': [{'pmid': '19853906', 'type': 'BACKGROUND', 'citation': 'Astrup A, Rossner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23.'}, {'pmid': '21844879', 'type': 'BACKGROUND', 'citation': 'Astrup A, Carraro R, Finer N, Harper A, Kunesova M, Lean ME, Niskanen L, Rasmussen MF, Rissanen A, Rossner S, Savolainen MJ, Van Gaal L; NN8022-1807 Investigators. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes (Lond). 2012 Jun;36(6):843-54. doi: 10.1038/ijo.2011.158. Epub 2011 Aug 16.'}, {'pmid': '18340209', 'type': 'BACKGROUND', 'citation': 'Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Fernando Costa. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute scientific statement: Executive Summary. Crit Pathw Cardiol. 2005 Dec;4(4):198-203. doi: 10.1097/00132577-200512000-00018. No abstract available.'}, {'pmid': '21121834', 'type': 'BACKGROUND', 'citation': 'Berrington de Gonzalez A, Hartge P, Cerhan JR, Flint AJ, Hannan L, MacInnis RJ, Moore SC, Tobias GS, Anton-Culver H, Freeman LB, Beeson WL, Clipp SL, English DR, Folsom AR, Freedman DM, Giles G, Hakansson N, Henderson KD, Hoffman-Bolton J, Hoppin JA, Koenig KL, Lee IM, Linet MS, Park Y, Pocobelli G, Schatzkin A, Sesso HD, Weiderpass E, Willcox BJ, Wolk A, Zeleniuch-Jacquotte A, Willett WC, Thun MJ. Body-mass index and mortality among 1.46 million white adults. N Engl J Med. 2010 Dec 2;363(23):2211-9. doi: 10.1056/NEJMoa1000367.'}, {'pmid': '22949540', 'type': 'BACKGROUND', 'citation': 'Despres JP. Body fat distribution and risk of cardiovascular disease: an update. Circulation. 2012 Sep 4;126(10):1301-13. doi: 10.1161/CIRCULATIONAHA.111.067264. 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PLoS One. 2014 Oct 24;9(10):e111283. doi: 10.1371/journal.pone.0111283. eCollection 2014.'}, {'pmid': '24871333', 'type': 'BACKGROUND', 'citation': 'Thomas MS, Newman D, Leinhard OD, Kasmai B, Greenwood R, Malcolm PN, Karlsson A, Rosander J, Borga M, Toms AP. Test-retest reliability of automated whole body and compartmental muscle volume measurements on a wide bore 3T MR system. Eur Radiol. 2014 Sep;24(9):2279-91. doi: 10.1007/s00330-014-3226-6. Epub 2014 May 29.'}, {'pmid': '15810802', 'type': 'BACKGROUND', 'citation': 'Human energy requirements: report of a joint FAO/ WHO/UNU Expert Consultation. Food Nutr Bull. 2005 Mar;26(1):166. No abstract available.'}, {'pmid': '34358471', 'type': 'DERIVED', 'citation': 'Neeland IJ, Marso SP, Ayers CR, Lewis B, Oslica R, Francis W, Rodder S, Pandey A, Joshi PH. Effects of liraglutide on visceral and ectopic fat in adults with overweight and obesity at high cardiovascular risk: a randomised, double-blind, placebo-controlled, clinical trial. Lancet Diabetes Endocrinol. 2021 Sep;9(9):595-605. doi: 10.1016/S2213-8587(21)00179-0. Epub 2021 Aug 3.'}]}, 'descriptionModule': {'briefSummary': 'This study is a clinical study to investigate the efficacy of liraglutide compared to placebo in reducing visceral adiposity measured by MRI in overweight or obese subjects at high risk for cardiovascular disease after 40 weeks on-treatment.', 'detailedDescription': 'Obesity has long been recognized as a risk factor for all-cause mortality and morbidity, including the development of cardiovascular and metabolic diseases such as coronary artery disease, hypertension, insulin resistance, diabetes, and dyslipidemia. Obesity has recently been formally defined as a chronic disease characterized by pathophysiological processes that result in increased adipose tissue mass and can result in increased morbidity and mortality. Although the health risks associated with obesity are clear, there is an emerging appreciation that obesity per se, as defined by simple anthropometric measures such as waist circumference or body mass index (BMI), is neither necessary nor sufficient to promote cardiometabolic disease and atherosclerotic cardiovascular disease (ASCVD) risk. As a result, BMI alone is an insufficient marker of risk and may not accurately identify individuals at elevated risk for ASCVD. There is a pressing need to more accurately phenotype obesity to identify individuals at elevated risk for ASCVD that may benefit from more intensive preventive and therapeutic strategies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 35 years\n* Able to provide informed consent\n* BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with metabolic syndrome\n* Metabolic syndrome is defined as at least three of the following:3\n\n 1. waist circumference \\> 102 cm (40 in) in men and 88 cm (35 in) in women\n 2. triglycerides \\> 150 mg/dL or on treatment for hypertriglyceridemia\n 3. HDL cholesterol \\< 40 mg/dL in men and \\< 50 mg/dL in women\n 4. blood pressure \\> 130/85 mmHg or on treatment for hypertension\n 5. fasting glucose \\> 100 mg/dL\n\nExclusion Criteria:\n\n* Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists (including liraglutide, exenatide or others as they become available), dipeptidyl peptidase 4 (DPP-4) inhibitors or insulin within the last 3 months.\n* Receipt of any anti-obesity drug or supplement within 1 month prior to screening for this trial.\n* Self-reported or clinically documented history of significant fluctuations (\\>5% change) in weight within 3 months prior to screening for this trial.\n* History of diabetes mellitus (type 1 or 2) or on treatment with anti-diabetes medication.\n* History of chronic pancreatitis or idiopathic acute pancreatitis (current or prior history).\n* History of gallbladder disease (cholelithiasis or cholecystitis).\n* Chronic kidney disease stage III or greater (eGFR\\<60 mL/min).\n* Obesity induced by other endocrinologic disorders (e.g. Cushing Syndrome).\n* Current or history of treatment with medications that may cause significant weight gain, within 1 month prior to screening for this trial, including systemic corticosteroids (except for a short course of treatment, i.e., 7- 10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine, amitryptiline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium).\n* Diet attempts using herbal supplements or over-the-counter medications within 1 month prior to screening for this trial.\n* Current participation in an organized weight reduction program or within the last 1 month prior to screening for this trial.\n* Participation in a clinical trial within the last 3 months prior to screening for this trial.\n* Familial or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma.\n* Personal history of non-familial medullary thyroid carcinoma.\n* History of Major Depressive Disorder within the last 2 years.\n* History of other severe psychiatric disorders, e.g., schizophrenia, bipolar disorder.\n* Any lifetime history of a suicide attempt.\n* A history of any suicidal behavior in the last month prior to randomization.\n* Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator.\n* Known or suspected hypersensitivity to trial product(s) or related product(s).\n* Known or suspected abuse of alcohol or narcotics.\n* Language barrier, mental incapacity, unwillingness or inability to understand.\n* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. These include abstinence and the following methods: diaphragm with spermicide, condom with spermicide (by male partner), intrauterine device, sponge, spermicide, Norplant®, Depo-Provera® or oral contraceptives.'}, 'identificationModule': {'nctId': 'NCT03038620', 'briefTitle': 'Impact of Liraglutide 3.0 on Body Fat Distribution', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Impact of Liraglutide 3.0 on Body Fat Distribution, Visceral Adiposity, and Cardiometabolic Risk Markers In Overweight and Obese Adults at High Risk for Cardiovascular Disease', 'orgStudyIdInfo': {'id': 'STU 122015-044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liraglutide 3.0 mg', 'description': 'Drug: Liraglutide Active Drug\n\nOther Names:\n\n* Saxenda\n\nEscalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.', 'interventionNames': ['Drug: Liraglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL\n\nOther Names:\n\n* Placebo\n* Saline injection\n\nEscalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['Saxenda'], 'description': 'Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.', 'armGroupLabels': ['Liraglutide 3.0 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saline injection'], 'description': 'Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Parag Joshi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Parag Joshi', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}