Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-07 @ 7:23 AM
Study NCT ID:
NCT02912260
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2016-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C588408', 'term': 'resmetirom'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thare@madrigalpharma.com', 'phone': '267-268-7800', 'title': 'Thomas Hare', 'organization': 'Madrigal Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release up to 45 days prior to submission and can embargo communications regarding study results for a period that is more than 90 days from the date that the communication is submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Screening up to Week 36', 'description': 'Safety population: all randomized participants who received at least 1 dose of study drug. No summaries of AEs by dose level were planned or performed.', 'eventGroups': [{'id': 'EG000', 'title': 'MGL-3196 Main Study', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 73, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo Main Study', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 28, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Extension Study', 'description': 'Patients randomized to MGL-3196 during the Main Study remained on the same dose of MGL-3196 or had a prespecified increase in dose upon entering the Extension Study. Former placebo patients were treated with 80 mg MGL-3196 initially, then up-titrated to 100 mg, remained on 80 mg, or had their dose reduced to 60 mg at Week 4 based on a PK sample obtained during Week 2.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 6, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 49, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bile duct stones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline To Week 12 In Hepatic Fat Fraction Assessed By Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.9', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.5', 'ciLowerLimit': '-32.9', 'ciUpperLimit': '-12.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.22', 'groupDescription': 'LS mean difference in hepatic fat fraction between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'The primary endpoint was relative change in MRI-PDFF assessed hepatic fat fraction compared with placebo at Week 12 in participants who had both a baseline and Week 12 MRI-PDFF. Least squares (LS) mean was provided for the statistical comparison of MGL-3196 versus placebo.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '46.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000'}, {'value': '68.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 and Week 36', 'description': 'An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline To Week 36 In Hepatic Fat Fraction Assessed By MRI-PDFF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.3', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '-8.9', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.4', 'ciLowerLimit': '-41.3', 'ciUpperLimit': '-15.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.52', 'groupDescription': 'LS mean difference in hepatic fat fraction between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 36', 'description': 'The endpoint was relative change assessed hepatic fat fraction compared with placebo at Week 36. LS mean was provided for the statistical comparison of MGL-3196 versus placebo.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To Week 12 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.3', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '-2.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.991', 'groupDescription': 'LS mean difference in absolute hepatic fat fraction between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'The endpoint was change in MRI-PDFF assessed absolute hepatic fat fraction compared with placebo at Week 12. LS mean was provided for the comparison of MGL-3196 versus placebo.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To Week 36 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '-2.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.260', 'groupDescription': 'LS mean difference in absolute hepatic fat fraction between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 36', 'description': 'The endpoint was change in assessed absolute hepatic fat fraction compared with placebo at Week 36. LS mean was provided for the comparison of MGL-3196 versus placebo.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants With At Least 30% Relative Fat Reduction at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The endpoint presented the percentage of participants achieving a relative fat reduction of ≥30% at Week 12.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants With At Least 30% Relative Fat Reduction At Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000'}, {'value': '29.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'The endpoint presented the percentage of participants achieving a relative fat reduction of ≥30% at Week 36.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants Achieving A 1-Point Reduction In Non-alcoholic Fatty Liver Disease Activity Score (NAS) At Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.7', 'groupId': 'OG000'}, {'value': '64.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for non-alcoholic steatohepatitis (NASH) activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 1-point or greater reduction in NAS.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants Achieving A 2-Point Reduction In NAS At Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.2', 'groupId': 'OG000'}, {'value': '32.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants Achieving A 2-Point Reduction In NAS And Either A ≥1-Point Reduction In Lobular Inflammation Or Hepatocellular Ballooning At Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000'}, {'value': '32.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS and a 1-point or greater reduction in lobular inflammation or hepatocellular ballooning.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants Achieving A 2-Point Reduction In NAS Without Fibrosis Worsening At Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000'}, {'value': '32.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). Fibrosis stage (0 to 3) was also included in the assessment. The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS without worsening fibrosis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants With A Reduction In Hepatocellular Steatosis At Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'groupId': 'OG000'}, {'value': '44.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a reduction in hepatocellular steatosis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants With A Reduction In Lobular Inflammation At Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a reduction in lobular inflammation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants With A Reduction In Hepatocellular Ballooning At Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000'}, {'value': '58.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a reduction in hepatocellular ballooning.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants Achieving NASH Resolution With At Least 2-Point Reduction In NAS At Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'The endpoint presented the percentage of participants achieving NASH resolution with a 2-point reduction at Week 36.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline To Week 12 In High-sensitivity C-reactive Protein (hsCRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '18.36', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '25.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6155', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.0', 'ciLowerLimit': '-47.0', 'ciUpperLimit': '79.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '31.81', 'groupDescription': 'LS mean difference in hsCRP between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'hsCRP was used as a non-invasive inflammation marker for this study. Blood samples were collected to determine the effect of MGL-3196 on hsCRP.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline To Week 36 In hsCRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.9', 'spread': '67.52', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '96.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6311', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '56.9', 'ciLowerLimit': '-177.4', 'ciUpperLimit': '291.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '118.09', 'groupDescription': 'LS mean difference in hsCRP between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 36', 'description': 'hsCRP was used as a non-invasive inflammation marker for this study. Blood samples were collected to determine the effect of MGL-3196 on hsCRP.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To Week 12 In Serum Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.2', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5260', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-12.4', 'ciUpperLimit': '6.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.73', 'groupDescription': 'LS mean difference in ALT between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on serum ALT.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To Week 36 In ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.4', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.4', 'ciLowerLimit': '-42.8', 'ciUpperLimit': '-9.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.29', 'groupDescription': 'LS mean difference in ALT between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 36', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on serum ALT.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To Week 12 In Serum Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1275', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.8', 'ciLowerLimit': '-10.9', 'ciUpperLimit': '1.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.10', 'groupDescription': 'LS mean difference in AST between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on serum AST.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To Week 36 In AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.4', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.1', 'ciLowerLimit': '-17.8', 'ciUpperLimit': '-4.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.42', 'groupDescription': 'LS mean difference in ALT between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 36', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on serum AST.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline To Week 12 In Lipid Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'title': 'LDL-C', 'categories': [{'measurements': [{'value': '-10.6', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.79', 'groupId': 'OG001'}]}]}, {'title': 'HDL-C', 'categories': [{'measurements': [{'value': '5.0', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.72', 'groupId': 'OG001'}]}]}, {'title': 'non-HDL-C', 'categories': [{'measurements': [{'value': '-12.1', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.47', 'groupId': 'OG001'}]}]}, {'title': 'TC', 'categories': [{'measurements': [{'value': '-8.7', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'TG', 'categories': [{'measurements': [{'value': '-6.8', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '6.01', 'groupId': 'OG001'}]}]}, {'title': 'ApoB', 'categories': [{'measurements': [{'value': '-14.5', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'ApoCIII', 'categories': [{'measurements': [{'value': '-9.1', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '4.62', 'groupId': 'OG001'}]}]}, {'title': 'Lp(a)', 'categories': [{'measurements': [{'value': '-8.6', 'spread': '7.54', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '10.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.9', 'ciLowerLimit': '-19.6', 'ciUpperLimit': '-6.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.41', 'groupDescription': 'LS mean difference in LDL-C between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3388', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '9.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.33', 'groupDescription': 'LS mean difference in HDL-C between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.4', 'ciLowerLimit': '-19.3', 'ciUpperLimit': '-7.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.02', 'groupDescription': 'LS mean difference in non-HDL-C between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.6', 'ciLowerLimit': '-14.3', 'ciUpperLimit': '-4.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.39', 'groupDescription': 'LS mean difference in TC between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0258', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.6', 'ciLowerLimit': '-31.2', 'ciUpperLimit': '-2.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.35', 'groupDescription': 'LS mean difference in TG between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-20.8', 'ciUpperLimit': '-9.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.76', 'groupDescription': 'LS mean difference in ApoB between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.8', 'ciLowerLimit': '-28.9', 'ciUpperLimit': '-6.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.64', 'groupDescription': 'LS mean difference in ApoCIII between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1123', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.9', 'ciLowerLimit': '-46.8', 'ciUpperLimit': '5.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.06', 'groupDescription': 'LS mean difference in Lp(a) between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on lipid parameters including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, total cholesterol (TC), triglycerides (TG), apolipoprotein B (ApoB), and Apolipoprotein CIII (ApoCIII).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline To Week 36 In Lipid Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'title': 'LDL-C', 'categories': [{'measurements': [{'value': '-11.0', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '3.11', 'groupId': 'OG001'}]}]}, {'title': 'HDL-C', 'categories': [{'measurements': [{'value': '10.5', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '5.41', 'groupId': 'OG001'}]}]}, {'title': 'non-HDL-C', 'categories': [{'measurements': [{'value': '-14.0', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.76', 'groupId': 'OG001'}]}]}, {'title': 'TC', 'categories': [{'measurements': [{'value': '-8.9', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '2.34', 'groupId': 'OG001'}]}]}, {'title': 'TG', 'categories': [{'measurements': [{'value': '-19.8', 'spread': '4.29', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '6.24', 'groupId': 'OG001'}]}]}, {'title': 'ApoB', 'categories': [{'measurements': [{'value': '-16.5', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.58', 'groupId': 'OG001'}]}]}, {'title': 'ApoCIII', 'categories': [{'measurements': [{'value': '-12.0', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '24.5', 'spread': '5.42', 'groupId': 'OG001'}]}]}, {'title': 'Lp(a)', 'categories': [{'measurements': [{'value': '19.0', 'spread': '10.95', 'groupId': 'OG000'}, {'value': '39.0', 'spread': '15.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.4', 'ciLowerLimit': '-19.9', 'ciUpperLimit': '-5.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.77', 'groupDescription': 'LS mean difference in LDL-C between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8213', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-14.5', 'ciUpperLimit': '11.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.56', 'groupDescription': 'LS mean difference in HDL-C between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.1', 'ciLowerLimit': '-22.7', 'ciUpperLimit': '-9.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.35', 'groupDescription': 'LS mean difference in nonHDL-C between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.5', 'ciLowerLimit': '-18.1', 'ciUpperLimit': '-6.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.83', 'groupDescription': 'LS mean difference in TC between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.3', 'ciLowerLimit': '-52.3', 'ciUpperLimit': '-22.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.58', 'groupDescription': 'LS mean difference in TG between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.4', 'ciLowerLimit': '-23.6', 'ciUpperLimit': '-11.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.14', 'groupDescription': 'LS mean difference in ApoB between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.5', 'ciLowerLimit': '-49.6', 'ciUpperLimit': '-23.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.58', 'groupDescription': 'LS mean difference in ApoCIII between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.0', 'ciLowerLimit': '-58.2', 'ciUpperLimit': '18.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '19.24', 'groupDescription': 'LS mean difference in Lp(a) between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 36', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on lipid parameters including LDL-C, HDL-C, non-HDL-C, TC, TG, ApoB, and ApoCIII.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline To Week 12 In Lipid Parameter Lipoprotein(a) (Lp[a])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.6', 'spread': '7.54', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '10.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1123', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.9', 'ciLowerLimit': '-46.8', 'ciUpperLimit': '5.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.06', 'groupDescription': 'LS mean difference in Lp(a) between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on lipid parameter Lp(a).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline To Week 36 In Lipid Parameter Lp[a]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'spread': '10.95', 'groupId': 'OG000'}, {'value': '39.0', 'spread': '15.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.0', 'ciLowerLimit': '-58.2', 'ciUpperLimit': '18.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '19.24', 'groupDescription': 'LS mean difference in Lp(a) between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 36', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on lipid parameter Lp(a).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To Week 12 And Week 36 In Cytokeratin-18 (CK-18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-146.2', 'spread': '35', 'groupId': 'OG000'}, {'value': '-87.5', 'spread': '51', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-272.0', 'spread': '33', 'groupId': 'OG000'}, {'value': '-101.0', 'spread': '47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3419', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-58.75', 'ciLowerLimit': '-180.70', 'ciUpperLimit': '63.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '61.551', 'groupDescription': 'LS mean difference in CK-18 between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-171.24', 'ciLowerLimit': '-285.06', 'ciUpperLimit': '-57.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '57.423', 'groupDescription': 'LS mean difference in CK-18 between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12 and Week 36', 'description': 'Serum CK-18 fragments, detected using the M30 antibody, is a non-invasive biomarker for NASH that may reflect hepatocyte apoptosis.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To Week 12 And Week 36 In Enhanced Liver Fibrosis (ELF) Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0089', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.395', 'ciLowerLimit': '-0.686', 'ciUpperLimit': '-0.103', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1458', 'groupDescription': 'LS mean difference in ELF-test between MGL-3196 and placebo at Week 12.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0174', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.484', 'ciLowerLimit': '-0.879', 'ciUpperLimit': '-0.088', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1973', 'groupDescription': 'LS mean difference in ELF test between MGL-3196 and placebo at Week 36.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12 and Week 36', 'description': 'The ELF Test is a non-invasive blood test that provides a simple, unitless numeric score that is used as a marker of collagen formation and fibrogenic activity and can be used to assess the risk of progression to cirrhosis. Scores below 9.8 indicate low risk of disease progression, and scores above 11.29 indicate high risk. The ELF score is derived from values of three serum biomarkers: hyaluronic acid (HA), procollagen III N-terminal peptide (PIIINP), and tissue inhibitor of metalloproteinase-1 (TIMP-1). The formula is 2.278 + 0.851 × ln(HA) + 0.751 × ln(PIIINP) + 0.394 × ln(TIMP-1); there are no minimum or maximum values.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline To Week 12 And Week 36 In Fibrosis-4 (Fib-4) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.386', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.374', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.356', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.436', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 and Week 36', 'description': 'The Fib-4 score is a scoring system used to estimate the amount of scarring in the liver. It is based on common clinical parameters (age, AST, ALT, and platelets) and has been shown to have the best diagnostic accuracy for advanced fibrosis when compared with other noninvasive clinical scores. Scores are categorized into low (\\<1.30), indeterminate (1.30-2.67), or high (\\>2.67) risk of fibrosis. The formula for Fib-4 is: (Age \\[yr\\] x AST \\[U/L\\]) / ((PLT \\[109/L\\]) x (ALT \\[U/L\\])½); there are no minimum or maximum values', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Thyrotropin at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.096', 'spread': '0.9136', 'groupId': 'OG000'}, {'value': '-0.101', 'spread': '0.9742', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 12', 'description': 'Thyrotropin (TSH) was assessed at each study visit.', 'unitOfMeasure': 'mIU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Total Thyroxine at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.18', 'spread': '0.958', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.726', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 12', 'description': 'Total thyroxine (FT4) was assessed at each study visit.', 'unitOfMeasure': 'μg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Free Thyroxine at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.147', 'spread': '0.1154', 'groupId': 'OG000'}, {'value': '0.001', 'spread': '0.0930', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 12', 'description': 'Free thyroxine (FT4) was assessed at each study visit.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Total Triiodothyronine at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.189', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.236', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 12', 'description': 'Total Triiodothyronine (T3) was assessed at each study visit.', 'unitOfMeasure': 'μg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Free Triiodothyronine at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.363', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.513', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 12', 'description': 'Free triiodothyronine (T3) was assessed at each study visit.', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Thyroxine Binding Globulin at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.42', 'spread': '3.859', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '3.522', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 12', 'description': 'Thyroxine Binding Globulin was assessed at each study visit.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Reverse Triiodothyronine Globulin at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.22', 'spread': '5.255', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '5.757', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 12', 'description': 'Reverse Triiodothyronine (T3) was assessed at each study visit.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Thyrotropin at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.034', 'spread': '0.9705', 'groupId': 'OG000'}, {'value': '0.043', 'spread': '0.9481', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 36', 'description': 'Tyrotropin (TSH) was assessed at each study visit.', 'unitOfMeasure': 'mIU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Total Thyroxine at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.10', 'spread': '1.013', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.846', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 36', 'description': 'Total thyroxine (FT4), thyrotropin (TSH) was assessed at each study visit.', 'unitOfMeasure': 'μg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Free Thyroxine Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.138', 'spread': '0.1280', 'groupId': 'OG000'}, {'value': '-0.007', 'spread': '0.1162', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 36', 'description': 'Total free thyroxine (FT4) was assessed at each study visit.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Total Triiodothyronine at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.212', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.190', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 36', 'description': 'Total triiodothyronine (T3) was assessed at each study visit.', 'unitOfMeasure': 'μg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Free Triiodothyronine at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.404', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.475', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 36', 'description': 'Free triiodothyronine (T3) was assessed at each study visit.', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Thyroxine-Binding Globulin at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.38', 'spread': '4.411', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '5.639', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 36', 'description': 'Thyroxine-binding globulin (TBG) was assessed at each study visit.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Reverse Triiodothyronine at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.41', 'spread': '5.582', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '5.493', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 36', 'description': 'Reverse triiodothyronine (T3) was assessed at each study visit.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}], 'periods': [{'title': 'Main Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Extension Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants underwent screening procedures within 42 days of randomization. To participate in the study, participants were required to have had a qualifying liver biopsy within 180 days of randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MGL-3196', 'description': 'Randomized participants received MGL-3196 80 mg orally once daily in the morning for 36 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Randomized participants received matching placebo orally once daily in the morning for 36 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'spread': '10.35', 'groupId': 'BG000'}, {'value': '47.3', 'spread': '11.71', 'groupId': 'BG001'}, {'value': '50.3', 'spread': '10.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '66', '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': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '117', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatic Fat Fraction by MRI-PDFF at Screening', 'classes': [{'categories': [{'measurements': [{'value': '20.25', 'spread': '6.843', 'groupId': 'BG000'}, {'value': '19.63', 'spread': '8.159', 'groupId': 'BG001'}, {'value': '20.05', 'spread': '7.274', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-26', 'size': 6610655, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-26T16:08', 'hasProtocol': True}, {'date': '2019-05-08', 'size': 1090956, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-09-26T16:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2016-09-19', 'resultsFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2016-09-20', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-18', 'studyFirstPostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline To Week 12 In Hepatic Fat Fraction Assessed By Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)', 'timeFrame': 'Week 12', 'description': 'The primary endpoint was relative change in MRI-PDFF assessed hepatic fat fraction compared with placebo at Week 12 in participants who had both a baseline and Week 12 MRI-PDFF. Least squares (LS) mean was provided for the statistical comparison of MGL-3196 versus placebo.'}], 'secondaryOutcomes': [{'measure': 'Percentage Of Participants With Adverse Events (AEs)', 'timeFrame': 'Week 12 and Week 36', 'description': 'An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.'}, {'measure': 'Percent Change From Baseline To Week 36 In Hepatic Fat Fraction Assessed By MRI-PDFF', 'timeFrame': 'Week 36', 'description': 'The endpoint was relative change assessed hepatic fat fraction compared with placebo at Week 36. LS mean was provided for the statistical comparison of MGL-3196 versus placebo.'}, {'measure': 'Change From Baseline To Week 12 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF', 'timeFrame': 'Week 12', 'description': 'The endpoint was change in MRI-PDFF assessed absolute hepatic fat fraction compared with placebo at Week 12. LS mean was provided for the comparison of MGL-3196 versus placebo.'}, {'measure': 'Change From Baseline To Week 36 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF', 'timeFrame': 'Week 36', 'description': 'The endpoint was change in assessed absolute hepatic fat fraction compared with placebo at Week 36. LS mean was provided for the comparison of MGL-3196 versus placebo.'}, {'measure': 'Percentage Of Participants With At Least 30% Relative Fat Reduction at Week 12', 'timeFrame': 'Week 12', 'description': 'The endpoint presented the percentage of participants achieving a relative fat reduction of ≥30% at Week 12.'}, {'measure': 'Percentage Of Participants With At Least 30% Relative Fat Reduction At Week 36', 'timeFrame': 'Week 36', 'description': 'The endpoint presented the percentage of participants achieving a relative fat reduction of ≥30% at Week 36.'}, {'measure': 'Percentage Of Participants Achieving A 1-Point Reduction In Non-alcoholic Fatty Liver Disease Activity Score (NAS) At Week 36', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for non-alcoholic steatohepatitis (NASH) activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 1-point or greater reduction in NAS.'}, {'measure': 'Percentage Of Participants Achieving A 2-Point Reduction In NAS At Week 36', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS.'}, {'measure': 'Percentage Of Participants Achieving A 2-Point Reduction In NAS And Either A ≥1-Point Reduction In Lobular Inflammation Or Hepatocellular Ballooning At Week 36', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS and a 1-point or greater reduction in lobular inflammation or hepatocellular ballooning.'}, {'measure': 'Percentage Of Participants Achieving A 2-Point Reduction In NAS Without Fibrosis Worsening At Week 36', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). Fibrosis stage (0 to 3) was also included in the assessment. The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS without worsening fibrosis.'}, {'measure': 'Percentage Of Participants With A Reduction In Hepatocellular Steatosis At Week 36', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a reduction in hepatocellular steatosis.'}, {'measure': 'Percentage Of Participants With A Reduction In Lobular Inflammation At Week 36', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a reduction in lobular inflammation.'}, {'measure': 'Percentage Of Participants With A Reduction In Hepatocellular Ballooning At Week 36', 'timeFrame': 'Week 36', 'description': 'The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a reduction in hepatocellular ballooning.'}, {'measure': 'Percentage Of Participants Achieving NASH Resolution With At Least 2-Point Reduction In NAS At Week 36', 'timeFrame': 'Week 36', 'description': 'The endpoint presented the percentage of participants achieving NASH resolution with a 2-point reduction at Week 36.'}, {'measure': 'Percent Change From Baseline To Week 12 In High-sensitivity C-reactive Protein (hsCRP)', 'timeFrame': 'Week 12', 'description': 'hsCRP was used as a non-invasive inflammation marker for this study. Blood samples were collected to determine the effect of MGL-3196 on hsCRP.'}, {'measure': 'Percent Change From Baseline To Week 36 In hsCRP', 'timeFrame': 'Week 36', 'description': 'hsCRP was used as a non-invasive inflammation marker for this study. Blood samples were collected to determine the effect of MGL-3196 on hsCRP.'}, {'measure': 'Change From Baseline To Week 12 In Serum Alanine Aminotransferase (ALT)', 'timeFrame': 'Week 12', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on serum ALT.'}, {'measure': 'Change From Baseline To Week 36 In ALT', 'timeFrame': 'Week 36', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on serum ALT.'}, {'measure': 'Change From Baseline To Week 12 In Serum Aspartate Aminotransferase (AST)', 'timeFrame': 'Week 12', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on serum AST.'}, {'measure': 'Change From Baseline To Week 36 In AST', 'timeFrame': 'Week 36', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on serum AST.'}, {'measure': 'Percent Change From Baseline To Week 12 In Lipid Parameters', 'timeFrame': 'Week 12', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on lipid parameters including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, total cholesterol (TC), triglycerides (TG), apolipoprotein B (ApoB), and Apolipoprotein CIII (ApoCIII).'}, {'measure': 'Percent Change From Baseline To Week 36 In Lipid Parameters', 'timeFrame': 'Week 36', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on lipid parameters including LDL-C, HDL-C, non-HDL-C, TC, TG, ApoB, and ApoCIII.'}, {'measure': 'Percent Change From Baseline To Week 12 In Lipid Parameter Lipoprotein(a) (Lp[a])', 'timeFrame': 'Week 12', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on lipid parameter Lp(a).'}, {'measure': 'Percent Change From Baseline To Week 36 In Lipid Parameter Lp[a]', 'timeFrame': 'Week 36', 'description': 'Blood samples were collected to determine the effect of MGL-3196 on lipid parameter Lp(a).'}, {'measure': 'Change From Baseline To Week 12 And Week 36 In Cytokeratin-18 (CK-18)', 'timeFrame': 'Week 12 and Week 36', 'description': 'Serum CK-18 fragments, detected using the M30 antibody, is a non-invasive biomarker for NASH that may reflect hepatocyte apoptosis.'}, {'measure': 'Change From Baseline To Week 12 And Week 36 In Enhanced Liver Fibrosis (ELF) Test', 'timeFrame': 'Week 12 and Week 36', 'description': 'The ELF Test is a non-invasive blood test that provides a simple, unitless numeric score that is used as a marker of collagen formation and fibrogenic activity and can be used to assess the risk of progression to cirrhosis. Scores below 9.8 indicate low risk of disease progression, and scores above 11.29 indicate high risk. The ELF score is derived from values of three serum biomarkers: hyaluronic acid (HA), procollagen III N-terminal peptide (PIIINP), and tissue inhibitor of metalloproteinase-1 (TIMP-1). The formula is 2.278 + 0.851 × ln(HA) + 0.751 × ln(PIIINP) + 0.394 × ln(TIMP-1); there are no minimum or maximum values.'}, {'measure': 'Change From Baseline To Week 12 And Week 36 In Fibrosis-4 (Fib-4) Score', 'timeFrame': 'Week 12 and Week 36', 'description': 'The Fib-4 score is a scoring system used to estimate the amount of scarring in the liver. It is based on common clinical parameters (age, AST, ALT, and platelets) and has been shown to have the best diagnostic accuracy for advanced fibrosis when compared with other noninvasive clinical scores. Scores are categorized into low (\\<1.30), indeterminate (1.30-2.67), or high (\\>2.67) risk of fibrosis. The formula for Fib-4 is: (Age \\[yr\\] x AST \\[U/L\\]) / ((PLT \\[109/L\\]) x (ALT \\[U/L\\])½); there are no minimum or maximum values'}, {'measure': 'Change From Baseline of Thyrotropin at Week 12', 'timeFrame': 'Baseline up to Week 12', 'description': 'Thyrotropin (TSH) was assessed at each study visit.'}, {'measure': 'Change From Baseline of Total Thyroxine at Week 12', 'timeFrame': 'Baseline up to Week 12', 'description': 'Total thyroxine (FT4) was assessed at each study visit.'}, {'measure': 'Change From Baseline of Free Thyroxine at Week 12', 'timeFrame': 'Baseline up to Week 12', 'description': 'Free thyroxine (FT4) was assessed at each study visit.'}, {'measure': 'Change From Baseline of Total Triiodothyronine at Week 12', 'timeFrame': 'Baseline up to Week 12', 'description': 'Total Triiodothyronine (T3) was assessed at each study visit.'}, {'measure': 'Change From Baseline of Free Triiodothyronine at Week 12', 'timeFrame': 'Baseline up to Week 12', 'description': 'Free triiodothyronine (T3) was assessed at each study visit.'}, {'measure': 'Change From Baseline of Thyroxine Binding Globulin at Week 12', 'timeFrame': 'Baseline up to Week 12', 'description': 'Thyroxine Binding Globulin was assessed at each study visit.'}, {'measure': 'Change From Baseline of Reverse Triiodothyronine Globulin at Week 12', 'timeFrame': 'Baseline up to Week 12', 'description': 'Reverse Triiodothyronine (T3) was assessed at each study visit.'}, {'measure': 'Change From Baseline of Thyrotropin at Week 36', 'timeFrame': 'Baseline up to Week 36', 'description': 'Tyrotropin (TSH) was assessed at each study visit.'}, {'measure': 'Change From Baseline of Total Thyroxine at Week 36', 'timeFrame': 'Baseline up to Week 36', 'description': 'Total thyroxine (FT4), thyrotropin (TSH) was assessed at each study visit.'}, {'measure': 'Change From Baseline of Free Thyroxine Week 36', 'timeFrame': 'Baseline up to Week 36', 'description': 'Total free thyroxine (FT4) was assessed at each study visit.'}, {'measure': 'Change From Baseline of Total Triiodothyronine at Week 36', 'timeFrame': 'Baseline up to Week 36', 'description': 'Total triiodothyronine (T3) was assessed at each study visit.'}, {'measure': 'Change From Baseline of Free Triiodothyronine at Week 36', 'timeFrame': 'Baseline up to Week 36', 'description': 'Free triiodothyronine (T3) was assessed at each study visit.'}, {'measure': 'Change From Baseline of Thyroxine-Binding Globulin at Week 36', 'timeFrame': 'Baseline up to Week 36', 'description': 'Thyroxine-binding globulin (TBG) was assessed at each study visit.'}, {'measure': 'Change From Baseline of Reverse Triiodothyronine at Week 36', 'timeFrame': 'Baseline up to Week 36', 'description': 'Reverse triiodothyronine (T3) was assessed at each study visit.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non-alcoholic Steatohepatitis']}, 'referencesModule': {'references': [{'pmid': '37786277', 'type': 'DERIVED', 'citation': 'Harrison SA, Ratziu V, Anstee QM, Noureddin M, Sanyal AJ, Schattenberg JM, Bedossa P, Bashir MR, Schneider D, Taub R, Bansal M, Kowdley KV, Younossi ZM, Loomba R. Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis. Aliment Pharmacol Ther. 2024 Jan;59(1):51-63. doi: 10.1111/apt.17734. Epub 2023 Oct 2.'}, {'pmid': '34329774', 'type': 'DERIVED', 'citation': 'Younossi ZM, Stepanova M, Taub RA, Barbone JM, Harrison SA. Hepatic Fat Reduction Due to Resmetirom in Patients With Nonalcoholic Steatohepatitis Is Associated With Improvement of Quality of Life. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1354-1361.e7. doi: 10.1016/j.cgh.2021.07.039. Epub 2021 Jul 27.'}, {'pmid': '33860116', 'type': 'DERIVED', 'citation': 'Harrison SA, Bashir M, Moussa SE, McCarty K, Pablo Frias J, Taub R, Alkhouri N. Effects of Resmetirom on Noninvasive Endpoints in a 36-Week Phase 2 Active Treatment Extension Study in Patients With NASH. Hepatol Commun. 2021 Jan 4;5(4):573-588. doi: 10.1002/hep4.1657. eCollection 2021 Apr.'}, {'pmid': '31727409', 'type': 'DERIVED', 'citation': 'Harrison SA, Bashir MR, Guy CD, Zhou R, Moylan CA, Frias JP, Alkhouri N, Bansal MB, Baum S, Neuschwander-Tetri BA, Taub R, Moussa SE. Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2019 Nov 30;394(10213):2012-2024. doi: 10.1016/S0140-6736(19)32517-6. Epub 2019 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on the percent change in hepatic fat fraction from baseline in participants with biopsy-proven Non-alcoholic Steatohepatitis (NASH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria. Participants who meet all of the following criteria will be eligible to participate in the study:\n\n* Must be willing to participate in the study and provide written informed consent;\n* Male and female adults ≥18 years of age;\n* Female participants of child bearing potential with negative serum pregnancy (beta human chorionic gonadotropin) tests who are not breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control (that is, condoms, diaphragm, nonhormonal intrauterine device \\[IUD\\], or sexual abstinence \\[only if this is in line with the participant's current lifestyle\\]) throughout the study and for at least 1 month after study completion; hormonal contraception (estrogens stable ≥3 months) and hormonal IUDs are permitted if used with a secondary birth control measure (for example, condoms); or female participants of non-child bearing potential (that is, surgically \\[bilateral oophorectomy, hysterectomy, or tubal ligation\\] or naturally sterile \\[\\>12 consecutive months without menses\\]); Male participants who have sexual intercourse with a female partner of child bearing potential from the first dose of study drug until 1 month after study completion must be either surgically sterile (confirmed by documented azoospermia \\>90 days after the procedure) or agree to use a condom with spermicide. All male participants must agree not to donate sperm from the first dose of study drug until 1 month after study completion;\n* Must have confirmation of ≥10% liver fat content on magnetic resonance imaging proton density fat fraction;\n* Biopsy-proven NASH. Must have had prior liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a non-alcoholic fatty liver disease activity score (NAS) of ≥4 with a score of 1 or more in each of the following NAS components:\n\n * Steatosis (scored 0 to 3),\n * Ballooning degeneration (scored 0 to 2), and\n * Lobular inflammation (scored 0 to 3);\n* Must have documented historical (3 weeks to 6 months prior to the study entry) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels consistent with the screening ALT and AST values.\n\nExclusion Criteria. Participants who meet any of the following criteria will be excluded from participation in the study:\n\nNote: Unless otherwise specified, repeat testing may be performed in consultation with the Medical Monitor.\n\n* History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening;\n* Hyperthyroidism;\n* Participants on thyroid replacement therapy (with exceptions);\n* Prior or planned (during the study period) bariatric surgery (for example, gastroplasty, roux-en-Y gastric bypass);\n* Type 1 diabetes;\n* Uncontrolled Type 2 diabetes defined as Hemoglobin A1c (HbA1c) ≥ 9.5% at screening (participants with HbA1c ≥ 9.5% may be rescreened);\n* Use of obeticholic acid, ursodeoxycholic acid (Ursodiol® and Urso®), high dose vitamin E (\\>400 IU/day) unless on stable dose of vitamin E \\>400 IU/day for at least 6 months at the time of liver biopsy, or pioglitazone within 90 days prior to enrollment or since screening biopsy, whichever is longer;\n* Presence of cirrhosis on liver biopsy (stage 4 fibrosis);\n* Platelet count \\< 140,000/mm\\^3;\n* Clinical evidence of hepatic decompensation;\n* Evidence of other forms of chronic liver disease;\n* Active, serious medical disease with likely life expectancy \\<2 years;\n* Participation in an investigational new drug trial in the 30 days prior to randomization; or\n* Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the participant, or interfere with the study outcomes."}, 'identificationModule': {'nctId': 'NCT02912260', 'briefTitle': 'Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Madrigal Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-controlled Study of MGL-3196 in Patients With Non-alcoholic Steatohepatitis', 'orgStudyIdInfo': {'id': 'MGL-3196-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MGL-3196', 'description': 'Study Drug', 'interventionNames': ['Drug: MGL-3196']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MGL-3196', 'type': 'DRUG', 'armGroupLabels': ['MGL-3196']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Madrigal Research Site', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Madrigal Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'Madrigal Research Site', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Madrigal Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Rialto', 'state': 'California', 'country': 'United States', 'facility': 'Madrigal Research Site', 'geoPoint': {'lat': 34.1064, 'lon': -117.37032}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Madrigal Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Madrigal Research Site', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Madrigal Research Site', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Madrigal Research Site', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'city': 'Lakewood Rch', 'state': 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