Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-03-12 @ 3:21 PM
Study NCT ID:
NCT04147195
Status:
TERMINATED
Last Update Posted:
2023-08-21
First Post:
2019-10-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}}}, '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': 'C000630573', 'term': 'tropifexor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '+ 1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 113 days.', 'description': 'Any sign or symptom that occurs during the study treatment plus the 28 days post treatment', 'eventGroups': [{'id': 'EG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 9, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 15, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Total', 'description': 'Total', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 24, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'OG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to discontinuation of study treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 113 Days', 'description': 'Number of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory parameters qualifying and reported as AEs. The number of participants in each category is reported in the table.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'OG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'classes': [{'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.564', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.286', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.780', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.687', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.713', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.461', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Days 57, 85 and EOS (Day 113)', 'description': 'The markers of fibrosis assessed in this test comprised hyaluronic acid (HA), tissue inhibitor of metalloproteinase (TIMP1) and procollagen III N-terminal peptide (PIIINP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during fibrogenesis as a result of activation of the hepatic stellate cell. The ELF test is a composite score: \\< 7.7: no to mild fibrosis; ≥ 7.7 - \\< 9.8: Moderate fibrosis; ≥ 9.8 - \\< 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates decreased fibrosis.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cholesterol: Fasting Lipid Profile Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'OG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.025', 'spread': '0.5814', 'groupId': 'OG000'}, {'value': '0.086', 'spread': '0.8825', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.058', 'spread': '0.6058', 'groupId': 'OG000'}, {'value': '0.431', 'spread': '1.0688', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.109', 'spread': '0.6758', 'groupId': 'OG000'}, {'value': '0.474', 'spread': '1.0364', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.246', 'spread': '0.6341', 'groupId': 'OG000'}, {'value': '0.463', 'spread': '1.3026', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.8558', 'groupId': 'OG000'}, {'value': '0.754', 'spread': '0.9915', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.283', 'spread': '1.1182', 'groupId': 'OG000'}, {'value': '0.249', 'spread': '0.5175', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113)', 'description': 'Fasting lipid profile (total cholesterol) was examined as a cardiometabolic risk parameter. Total cholesterol was measured on blood samples under fasted conditions and analyzed at a central laboratory.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates cardiovascular risk.', 'unitOfMeasure': 'mmol / L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent Liver Fat at Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'OG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.74', 'spread': '3.470', 'groupId': 'OG000'}, {'value': '-7.52', 'spread': '5.846', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 85', 'description': 'Percent (%) Liver fat was measured by Magnetic Resonance Imaging Proton Density Liver Fat Fraction (MRIPDFF). Participants underwent magnetic resonance imaging twice during the course of the study (baseline and end of treatment) to quantitate liver fat.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates a reduction in a component of NAFLD.', 'unitOfMeasure': 'Percentage of Liver Fat', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed includes all participants in the PD analysis set with evaluable data for the endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'OG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '1.412', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '2.030', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '1.513', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '2.455', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.24', 'spread': '1.664', 'groupId': 'OG000'}, {'value': '-1.94', 'spread': '2.780', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '1.548', 'groupId': 'OG000'}, {'value': '-2.97', 'spread': '3.144', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '2.334', 'groupId': 'OG000'}, {'value': '-3.33', 'spread': '2.892', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '2.753', 'groupId': 'OG000'}, {'value': '-2.56', 'spread': '2.789', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113)', 'description': 'Body weight (to the nearest 0.1 kilogram \\[kg\\] was measured on a calibrated scale. The measurement was performed with the study participant in underwear and without shoes; or while wearing minimal indoor clothing.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in obesity.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'OG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.74', 'spread': '9.865', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '7.741', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 85', 'description': 'HOMA-IR is a test that uses a simultaneous fasting blood glucose test and fasting insulin test to accurately estimate the degree of insulin resistance (IR) and β-cell function (the cells of the pancreas that produce insulin). HOMA-IR scores are classified as follows: Insulin sensitive is considered less than 1.0, Healthy is considered 0.5-1.4, Above 1.8 is early insulin resistance and Above 2.7 is considered significant insulin resistance\n\nHOMA-IR= \\[Fasting glucose (mmol/L) x (fasting insulin (pmol/L)/6)\\] / 22.5\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in insulin sensitivity.', 'unitOfMeasure': 'HOMA-IR score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed includes all participants in the PD analysis set with evaluable data for the endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'OG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '2.609', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '2.402', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '3.541', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '2.362', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.53', 'spread': '3.655', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '2.449', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.82', 'spread': '3.176', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '1.960', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.74', 'spread': '3.810', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '2.023', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.01', 'spread': '3.627', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '1.563', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113)', 'description': 'Fasting Glucose was examined as a cardiometabolic risk parameter. Total fasting glucose was measured on blood samples under fasted conditions and analyzed at a central laboratory.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in glycemic control.', 'unitOfMeasure': 'mmol / L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Insulin at Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'OG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.36', 'spread': '139.23', 'groupId': 'OG000'}, {'value': '14.23', 'spread': '63.875', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 85', 'description': 'Fasting insulin was examined as a cardiometabolic risk parameter. Total fasting insulin was measured on blood samples under fasted conditions and analyzed at a central laboratory.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in insulin sensitivity.', 'unitOfMeasure': 'pmol / L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed includes all participants in the PD analysis set with evaluable data for the endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'OG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.194', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.338', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.431', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.487', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.544', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.884', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.730', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.680', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.834', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.863', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.961', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.359', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113)', 'description': 'HbA1c was examined as a cardiometabolic risk parameter. HbA1c was measured on blood samples under fasted conditions and analyzed at a central laboratory.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in glycemic control.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'OG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.97', 'spread': '18.255', 'groupId': 'OG000'}, {'value': '-19.75', 'spread': '25.617', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.92', 'spread': '22.166', 'groupId': 'OG000'}, {'value': '-9.63', 'spread': '13.774', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.13', 'spread': '21.624', 'groupId': 'OG000'}, {'value': '-8.68', 'spread': '14.573', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.09', 'spread': '25.401', 'groupId': 'OG000'}, {'value': '-17.04', 'spread': '12.841', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.21', 'spread': '34.702', 'groupId': 'OG000'}, {'value': '-11.14', 'spread': '26.318', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.50', 'spread': '29.619', 'groupId': 'OG000'}, {'value': '-8.05', 'spread': '14.570', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and days 15, 29, 43, 57, 85 and EOS (Day 113)', 'description': 'Alanine aminotransferase (ALT) is an enzyme found primarily in the liver. ALT is increased with liver damage. In this study, the blood levels of ALT was used to detect liver inflammation.\n\nBaseline is defined as the mean of the last 2 non-missing measurements taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates a reduction in liver inflammation.', 'unitOfMeasure': 'U / L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'OG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'classes': [{'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '2.192', 'groupId': 'OG000'}, {'value': '-7.78', 'spread': '27.500', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.62', 'spread': '2.180', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '1.692', 'groupId': 'OG001'}]}]}, {'title': 'EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '3.432', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '1.015', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Days 57, 85 and EOS (Day 113)', 'description': 'High-sensitivity C-reactive protein is a blood test marker for inflammation in the body. HsCRP was measured from a blood sample and analyzed at a central laboratory.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates a reduction in liver inflammation.', 'unitOfMeasure': 'mg / L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed includes all participants in the PD analysis set. The number analyzed per row represents participants with evaluable data at each time point.'}, {'type': 'SECONDARY', 'title': 'LYS006 Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'OG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'classes': [{'title': 'Day 1 (0 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.162', 'spread': '0.648', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (0 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.9', 'spread': '74.0', 'groupId': 'OG000'}, {'value': '53.5', 'spread': '74.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (1 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '174', 'spread': '89.6', 'groupId': 'OG000'}, {'value': '169', 'spread': '105', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (2 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '224', 'spread': '113', 'groupId': 'OG000'}, {'value': '189', 'spread': '105', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (3 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '188', 'spread': '89.8', 'groupId': 'OG000'}, {'value': '145', 'spread': '54.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (4 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '149', 'spread': '73.6', 'groupId': 'OG000'}, {'value': '110', 'spread': '31.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (0 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.0', 'spread': '57.2', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '21.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (1 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '200', 'spread': '118', 'groupId': 'OG000'}, {'value': '123', 'spread': '123', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (2 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '222', 'spread': '80.3', 'groupId': 'OG000'}, {'value': '198', 'spread': '88.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (3 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '188', 'spread': '74.3', 'groupId': 'OG000'}, {'value': '156', 'spread': '59.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (4 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '140', 'spread': '83.3', 'groupId': 'OG000'}, {'value': '126', 'spread': '54.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (0 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '18.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose at Days 1, 29, 57 and 85 and post-dose (1, 2, 3 and 4 hours) at Days 29 and 57', 'description': 'LYS006 plasma concentrations were determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. No methods for imputation of missing data were used.', 'unitOfMeasure': 'ng / mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed includes all participants. The number analyzed per row represents participants with evaluable data at each time point.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of LYS006', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'OG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '264', 'spread': '87.7', 'groupId': 'OG000'}, {'value': '215', 'spread': '98.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '271', 'spread': '71.1', 'groupId': 'OG000'}, {'value': '228', 'spread': '88.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose and post-dose (1, 2, 3 and 4 hours) at Days 29 and 57', 'description': 'LYS006 plasma concentrations were determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Cmax of LYS006 was determined with Phoenix WinNonlin (Version 8.0 or higher). No methods for imputation of missing data were used.', 'unitOfMeasure': 'ng / mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed includes all participants. The number analyzed per row represents participants with evaluable data at each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'FG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'PD Analysis Set', 'comment': 'Participants with available PD data and no major protocol deviations with impact on PD data.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from 10 sites in 3 countries.', 'preAssignmentDetails': 'Participants underwent a Screening period of up to 33 days followed by a Baseline assessment period of up to 27 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks'}, {'id': 'BG001', 'title': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'spread': '9.23', 'groupId': 'BG000'}, {'value': '54.9', 'spread': '8.36', 'groupId': 'BG001'}, {'value': '53.5', 'spread': '8.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-02', 'size': 944126, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-17T03:29', 'hasProtocol': True}, {'date': '2022-02-09', 'size': 419636, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-17T03:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-16', 'studyFirstSubmitDate': '2019-10-22', 'resultsFirstSubmitDate': '2022-11-17', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-10', 'studyFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 113 Days', 'description': 'Number of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory parameters qualifying and reported as AEs. The number of participants in each category is reported in the table.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score', 'timeFrame': 'Baseline and Days 57, 85 and EOS (Day 113)', 'description': 'The markers of fibrosis assessed in this test comprised hyaluronic acid (HA), tissue inhibitor of metalloproteinase (TIMP1) and procollagen III N-terminal peptide (PIIINP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during fibrogenesis as a result of activation of the hepatic stellate cell. The ELF test is a composite score: \\< 7.7: no to mild fibrosis; ≥ 7.7 - \\< 9.8: Moderate fibrosis; ≥ 9.8 - \\< 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates decreased fibrosis.'}, {'measure': 'Change From Baseline in Cholesterol: Fasting Lipid Profile Endpoint', 'timeFrame': 'Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113)', 'description': 'Fasting lipid profile (total cholesterol) was examined as a cardiometabolic risk parameter. Total cholesterol was measured on blood samples under fasted conditions and analyzed at a central laboratory.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates cardiovascular risk.'}, {'measure': 'Change From Baseline in Percent Liver Fat at Day 85', 'timeFrame': 'Baseline and Day 85', 'description': 'Percent (%) Liver fat was measured by Magnetic Resonance Imaging Proton Density Liver Fat Fraction (MRIPDFF). Participants underwent magnetic resonance imaging twice during the course of the study (baseline and end of treatment) to quantitate liver fat.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates a reduction in a component of NAFLD.'}, {'measure': 'Change From Baseline in Total Body Weight', 'timeFrame': 'Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113)', 'description': 'Body weight (to the nearest 0.1 kilogram \\[kg\\] was measured on a calibrated scale. The measurement was performed with the study participant in underwear and without shoes; or while wearing minimal indoor clothing.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in obesity.'}, {'measure': 'Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Day 85', 'timeFrame': 'Baseline and Day 85', 'description': 'HOMA-IR is a test that uses a simultaneous fasting blood glucose test and fasting insulin test to accurately estimate the degree of insulin resistance (IR) and β-cell function (the cells of the pancreas that produce insulin). HOMA-IR scores are classified as follows: Insulin sensitive is considered less than 1.0, Healthy is considered 0.5-1.4, Above 1.8 is early insulin resistance and Above 2.7 is considered significant insulin resistance\n\nHOMA-IR= \\[Fasting glucose (mmol/L) x (fasting insulin (pmol/L)/6)\\] / 22.5\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in insulin sensitivity.'}, {'measure': 'Change From Baseline in Fasting Glucose', 'timeFrame': 'Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113)', 'description': 'Fasting Glucose was examined as a cardiometabolic risk parameter. Total fasting glucose was measured on blood samples under fasted conditions and analyzed at a central laboratory.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in glycemic control.'}, {'measure': 'Change From Baseline in Fasting Insulin at Day 85', 'timeFrame': 'Baseline and Day 85', 'description': 'Fasting insulin was examined as a cardiometabolic risk parameter. Total fasting insulin was measured on blood samples under fasted conditions and analyzed at a central laboratory.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in insulin sensitivity.'}, {'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline and Days 15, 29, 43, 57, 85 and EOS (Day 113)', 'description': 'HbA1c was examined as a cardiometabolic risk parameter. HbA1c was measured on blood samples under fasted conditions and analyzed at a central laboratory.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates improvement in glycemic control.'}, {'measure': 'Change From Baseline in Alanine Aminotransferase (ALT)', 'timeFrame': 'Baseline and days 15, 29, 43, 57, 85 and EOS (Day 113)', 'description': 'Alanine aminotransferase (ALT) is an enzyme found primarily in the liver. ALT is increased with liver damage. In this study, the blood levels of ALT was used to detect liver inflammation.\n\nBaseline is defined as the mean of the last 2 non-missing measurements taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates a reduction in liver inflammation.'}, {'measure': 'Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)', 'timeFrame': 'Baseline and Days 57, 85 and EOS (Day 113)', 'description': 'High-sensitivity C-reactive protein is a blood test marker for inflammation in the body. HsCRP was measured from a blood sample and analyzed at a central laboratory.\n\nBaseline is defined as the last non-missing measurement taken at the Screening and Baseline visits (prior to the first dose of study drug administered at the Day 1). A negative change from Baseline indicates a reduction in liver inflammation.'}, {'measure': 'LYS006 Plasma Concentration', 'timeFrame': 'pre-dose at Days 1, 29, 57 and 85 and post-dose (1, 2, 3 and 4 hours) at Days 29 and 57', 'description': 'LYS006 plasma concentrations were determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. No methods for imputation of missing data were used.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of LYS006', 'timeFrame': 'pre-dose and post-dose (1, 2, 3 and 4 hours) at Days 29 and 57', 'description': 'LYS006 plasma concentrations were determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Cmax of LYS006 was determined with Phoenix WinNonlin (Version 8.0 or higher). No methods for imputation of missing data were used.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-alcoholic fatty liver disease', 'NAFLD', 'Non-alcoholic steatohepatitis', 'NASH', 'Platform design', 'LYS006', 'LJN452', 'Tropifexor'], 'conditions': ['Non-alcoholic Fatty Liver Disease', 'Nonalcoholic Steatohepatitis']}, 'referencesModule': {'references': [{'pmid': '41305844', 'type': 'DERIVED', 'citation': 'Frias J, Schmouder R, Lawitz E, Zhang Y, Zhou H, Badman MK, Ukomadu C, Weiss HM, Zack J, Yadav B, Martic M, Drakeford C, Koo P, Naoumov NV, Greenbaum LE. Clinical trial: A Phase 2 Randomised Platform Study to Assess Monotherapy and Combination Treatment Regimens in Metabolic Dysfunction-Associated Steatohepatitis. Aliment Pharmacol Ther. 2025 Nov 26. doi: 10.1111/apt.70475. Online ahead of print.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1455', 'label': 'A Plain Language Trial Summary is available on novctrd.com'}]}, 'descriptionModule': {'briefSummary': 'This clinical study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of various single and combination treatments in adult patients with non-alcoholic fatty liver disease (NAFLD) who manifest a non-alcoholic steatohepatitis (NASH)-like biomarker phenotype.', 'detailedDescription': 'This was a Phase II, non-confirmatory, multicenter, open label, platform study in NAFLD participants with a NASH-like biomarker phenotype to examine the effects of single and combination therapies over 12 weeks of treatment. The study consisted of four distinct study periods:\n\n* Screening Period (Day -60 to -28): Lasted up to a maximum of 33 days where participants were assessed for inclusion and exclusion criteria prior the baseline assessments.\n* Baseline Period (Day -27 to -1): Lasted up to a maximum of 27 days and comprised baseline assessments and randomization.\n* Treatment Period (Day 1 to 85): Participants were randomized in a 1:1 ratio to LYS006 20 mg (twice a day) arm or to LYS006 20 mg (twice a day) and tropifexor 200ug (once a day). Participants were treated daily during 12 weeks.\n* Follow-up Period (Day 85 to 113): After completion of the treatment period, participants were observed until the End Of Study (EOS) visit at Day 113.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPhenotypic diagnosis of NASH based on the presence of all of the following:\n\n* ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)\n* BMI ≥ 27 kg/m2 (race other than Asian) or ≥ 23 kg/m2 (Asian race)\n* History of type 2 diabetes mellitus with HbA1c ≤ 9%\n* ELF test score ≥ 8.5 and ≤ 10.5\n* Liver fat ≥ 8%\n* Patients must weigh between 40 kg (88 lbs.) and 150 kg (330 lbs.)\n\nExclusion Criteria:\n\n* Use of other investigational drugs within 5 half-lives of randomization or within 3 months, whichever is longer\n* Use of obeticholic acid (OCA) or pharmacologically-active weight loss drugs within 1 month of randomization\n* Use of strong CYP3A4/5 inhibitors or strong CYP3A4 inducers within 5 half-lives or 7 days of randomization, whichever is longer\n* History or presence of other concomitant liver diseases\n* History or current diagnosis of ECG abnormalities\n* Patients with contraindications to MRI imaging\n* Current or history of significant alcohol consumption\n* Clinical evidence of hepatic decompensation or severe liver impairment\n* Women of child bearing potential (unless on highly effective methods of contraception)\n* Presence of liver cirrhosis\n* Use of OAT3 inhibitors within 5 half-lives or 7 days of randomization, whichever is longer'}, 'identificationModule': {'nctId': 'NCT04147195', 'acronym': 'NEXSCOT', 'briefTitle': 'Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'NASH EXploratory Single and COmbination Treatment (NEXSCOT): An Open Label, Multicenter, Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Various Single and Combination Treatments in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) Who Manifest a Non-alcoholic Steatohepatitis (NASH)-Like Biomarker Phenotype', 'orgStudyIdInfo': {'id': 'CADPT02A12001'}, 'secondaryIdInfos': [{'id': '2018-002692-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LYS006', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) for 12 weeks', 'interventionNames': ['Drug: LYS006']}, {'type': 'EXPERIMENTAL', 'label': 'LYS006 + LJN452', 'description': 'LYS006 20 mg was administered orally twice per day (b.i.d) in addition to LJN452 200ug administered orally once daily for 12 weeks', 'interventionNames': ['Drug: Tropifexor']}], 'interventions': [{'name': 'LYS006', 'type': 'DRUG', 'description': '5 mg LYS006 capsules orally administered 20 mg b.i.d for 12 weeks', 'armGroupLabels': ['LYS006']}, {'name': 'Tropifexor', 'type': 'DRUG', 'otherNames': ['LJN452'], 'description': '100 ug LJN452 capsules orally administered 200ug once daily for 12 weeks', 'armGroupLabels': ['LYS006 + LJN452']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92118', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '46635', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'C1012AAR', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '45136', 'city': 'Essen', 'state': 'Nordrhine Westphalia', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}