Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-04-05 @ 1:46 AM
Study NCT ID:
NCT03823703
Status:
TERMINATED
Last Update Posted:
2022-08-31
First Post:
2019-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-07-29', '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': 'C000606526', 'term': 'CORT118335'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@corcept.com', 'phone': '650-327-3270', 'title': 'Medical Director', 'organization': 'Corcept Therapeutics Incorporated'}, 'certainAgreement': {'otherDetails': 'No individual publications will be allowed before publication of the multicenter results, except as agreed with the Sponsor. The Investigator agrees to submit all manuscripts or abstracts to the Sponsor for review before submission to the publisher.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to observations related to safety, the study was terminated by the Sponsor prior to completion. The sample size at the time of study termination did not support formal tests to assess statistical differences between treatment groups, and therefore, no efficacy analyses specified in the protocol were performed. Descriptive statistics for efficacy endpoints are provided, but since no patient reached the Week 12 visit, and therefore, descriptive statistics at Week 12 are not presented.'}}, 'adverseEventsModule': {'timeFrame': 'Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.', 'description': 'The analysis population included all patients who received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Miricorilant- 900 mg', 'description': 'Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Miricorilant- 600 mg', 'description': 'Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received 6 placebo tablets orally once daily.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Electrocardiogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant- 900 mg', 'description': 'Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.'}, {'id': 'OG001', 'title': 'Miricorilant- 600 mg', 'description': 'Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received 6 placebo tablets orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.28', 'spread': '13.723', 'groupId': 'OG000'}, {'value': '-22.94', 'spread': '71.943', 'groupId': 'OG001'}, {'value': '4.63', 'spread': '5.232', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to ~Day 95', 'description': 'The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: (\\[Post-Baseline LFC-Baseline LFC\\]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized to the study and had a post-baseline LFC assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant- 900 mg', 'description': 'Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.'}, {'id': 'OG001', 'title': 'Miricorilant- 600 mg', 'description': 'Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received 6 placebo tablets orally once daily.'}], 'classes': [{'title': 'Responders with a reduction in LFC from baseline of ≥30%', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Non-responders with a reduction in LFC from baseline of <30%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and up to ~Day 95', 'description': 'The number of participants (defined as responders) with a ≥30% reduction in LFC from baseline by treatment group as assessed by MRI-PDFF. The number of participants with a reduction in LFC from baseline of \\<30% were defined as non-responders. MRI-PDFF was performed at screening and up to 33 days after last dose of study drug. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized to the study and had a post-baseline LFC assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant- 900 mg', 'description': 'Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.'}, {'id': 'OG001', 'title': 'Miricorilant- 600 mg', 'description': 'Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received 6 placebo tablets orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '346.0', 'spread': 'NA', 'comment': 'No standard deviation because n=1.', 'groupId': 'OG000'}, {'value': '321.0', 'spread': 'NA', 'comment': 'No standard deviation because n=1.', 'groupId': 'OG001'}, {'value': '-9.5', 'spread': '3.54', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'The change in aspartate aminotransferase (AST) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.', 'unitOfMeasure': 'units per liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized to the study and had a post-baseline AST assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant- 900 mg', 'description': 'Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.'}, {'id': 'OG001', 'title': 'Miricorilant- 600 mg', 'description': 'Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received 6 placebo tablets orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '810.0', 'spread': 'NA', 'comment': 'No standard deviation because n=1.', 'groupId': 'OG000'}, {'value': '826.0', 'spread': 'NA', 'comment': 'No standard deviation because n=1.', 'groupId': 'OG001'}, {'value': '-16', 'spread': '2.83', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'The change in serum alanine aminotransferase (ALT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized to the study and had a post-baseline ALT assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Gamma-glutamyl Transferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant- 900 mg', 'description': 'Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.'}, {'id': 'OG001', 'title': 'Miricorilant- 600 mg', 'description': 'Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received 6 placebo tablets orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': 'NA', 'comment': 'No standard deviation because n=1.', 'groupId': 'OG000'}, {'value': '82.0', 'spread': 'NA', 'comment': 'No standard deviation because n=1.', 'groupId': 'OG001'}, {'value': '-26.0', 'spread': '31.11', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'The change in gamma-glutamyl transferase (GGT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized to the study and had a post-baseline GGT assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Propeptide of Type III Collagen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant- 900 mg', 'description': 'Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.'}, {'id': 'OG001', 'title': 'Miricorilant- 600 mg', 'description': 'Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received 6 placebo tablets orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': 'NA', 'comment': 'No standard deviation because n=1.', 'groupId': 'OG000'}, {'value': '-1.65', 'spread': '2.475', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'The change in serum propeptide of Type III collagen (pro-C3) from baseline at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.', 'unitOfMeasure': 'μg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized to the study and had a post-baseline pro-C3 assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Enhanced Liver Fibrosis Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant- 900 mg', 'description': 'Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.'}, {'id': 'OG001', 'title': 'Miricorilant- 600 mg', 'description': 'Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received 6 placebo tablets orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.050', 'spread': 'NA', 'comment': 'No standard deviation because n=1.', 'groupId': 'OG000'}, {'value': '0.225', 'spread': '0.459', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'The change in enhanced liver fibrosis (ELF) from baseline for each treatment group at the Week 6 visit is summarized. The ELF score combines 3 serum biomarkers (hyaluronic acid, tissue inhibitor of metalloproteinases-1 \\[TIMP-1\\] and type III procollagen \\[PIIINP\\]) which have been shown to correlate with the degree of liver fibrosis assessed by liver biopsy. Each of these markers is measured by an immunoassay and an ELF score is generated \\[ELF=2.278+0.851 ln(HA)+0.751 ln(PIIINP)+0.394 ln(TIMP-1)\\], from which a level of fibrosis severity can be determined; higher ELF scores are associated with worsening liver fibrosis. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.', 'unitOfMeasure': 'ELF score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who were randomized to the study and had a post-baseline liver fibrosis assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With a Relative Reduction in Liver Fat Content ≥50% by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) for Miricorilant Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant- 900 mg', 'description': 'Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.'}, {'id': 'OG001', 'title': 'Miricorilant- 600 mg', 'description': 'Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received 6 placebo tablets orally once daily.'}], 'classes': [{'title': 'Responders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Non-Responders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and up to ~Day 95', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Complete Resolution in Liver Fat by MRI-PDFF for Miricorilant Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant- 900 mg', 'description': 'Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.'}, {'id': 'OG001', 'title': 'Miricorilant- 600 mg', 'description': 'Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received 6 placebo tablets orally once daily.'}], 'classes': [{'title': 'Responders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Non-Responders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and up to ~Day 95', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Miricorilant- 900 mg', 'description': 'Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.'}, {'id': 'FG001', 'title': 'Miricorilant- 600 mg', 'description': 'Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received 6 placebo tablets orally once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Sponsor request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Twelve adult patients with presumed NASH were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Miricorilant- 900 mg', 'description': 'Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.'}, {'id': 'BG001', 'title': 'Miricorilant- 600 mg', 'description': 'Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received 6 placebo tablets orally once daily.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '14.74', 'groupId': 'BG000'}, {'value': '54.2', 'spread': '19.87', 'groupId': 'BG001'}, {'value': '43.3', 'spread': '15.15', 'groupId': 'BG002'}, {'value': '50.9', 'spread': '16.68', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Liver Fat Content (LFC) Assessed by MRI-PDFF', 'classes': [{'categories': [{'measurements': [{'value': '24.57', 'spread': '6.038', 'groupId': 'BG000'}, {'value': '15.70', 'spread': '6.536', 'groupId': 'BG001'}, {'value': '19.93', 'spread': '8.750', 'groupId': 'BG002'}, {'value': '19.33', 'spread': '7.526', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of liver fat content', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) & Gamma Glutamyl Transferase (GGT)', 'classes': [{'title': 'AST', 'categories': [{'measurements': [{'value': '35.7', 'spread': '8.14', 'groupId': 'BG000'}, {'value': '25.6', 'spread': '12.76', 'groupId': 'BG001'}, {'value': '31', 'spread': '4.08', 'groupId': 'BG002'}, {'value': '29.9', 'spread': '9.68', 'groupId': 'BG003'}]}]}, {'title': 'ALT', 'categories': [{'measurements': [{'value': '52.3', 'spread': '15.63', 'groupId': 'BG000'}, {'value': '33.2', 'spread': '15.94', 'groupId': 'BG001'}, {'value': '54.0', 'spread': '12.11', 'groupId': 'BG002'}, {'value': '44.9', 'spread': '16.86', 'groupId': 'BG003'}]}]}, {'title': 'GGT', 'categories': [{'measurements': [{'value': '52.7', 'spread': '19.63', 'groupId': 'BG000'}, {'value': '26.2', 'spread': '9.20', 'groupId': 'BG001'}, {'value': '59.0', 'spread': '50.29', 'groupId': 'BG002'}, {'value': '43.8', 'spread': '32.20', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Units/Liter (U/L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Propeptide of Type III Collagen (Pro-C3)', 'classes': [{'categories': [{'measurements': [{'value': '16.13', 'spread': '5.350', 'groupId': 'BG000'}, {'value': '11.20', 'spread': '2.189', 'groupId': 'BG001'}, {'value': '13.73', 'spread': '4.727', 'groupId': 'BG002'}, {'value': '13.28', 'spread': '4.159', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'micrograms/liter (μg/L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Enhanced Liver Fibrosis Score', 'classes': [{'categories': [{'measurements': [{'value': '9.713', 'spread': '1.011', 'groupId': 'BG000'}, {'value': '9.358', 'spread': '0.486', 'groupId': 'BG001'}, {'value': '9.330', 'spread': '0.805', 'groupId': 'BG002'}, {'value': '9.438', 'spread': '0.690', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ELF score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-07', 'size': 1938060, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-06T10:54', 'hasProtocol': True}, {'date': '2021-08-30', 'size': 3606919, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-06T10:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Suspended by sponsor, pending investigation of abnormal laboratory values in patients with NASH', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2019-01-14', 'resultsFirstSubmitDate': '2022-07-06', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-10', 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With a Relative Reduction in Liver Fat Content ≥50% by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) for Miricorilant Versus Placebo', 'timeFrame': 'Baseline and up to ~Day 95'}, {'measure': 'Number of Participants With Complete Resolution in Liver Fat by MRI-PDFF for Miricorilant Versus Placebo', 'timeFrame': 'Baseline and up to ~Day 95'}], 'primaryOutcomes': [{'measure': 'Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction', 'timeFrame': 'Baseline and up to ~Day 95', 'description': 'The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: (\\[Post-Baseline LFC-Baseline LFC\\]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF', 'timeFrame': 'Baseline and up to ~Day 95', 'description': 'The number of participants (defined as responders) with a ≥30% reduction in LFC from baseline by treatment group as assessed by MRI-PDFF. The number of participants with a reduction in LFC from baseline of \\<30% were defined as non-responders. MRI-PDFF was performed at screening and up to 33 days after last dose of study drug. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.'}, {'measure': 'Change From Baseline in Aspartate Aminotransferase', 'timeFrame': 'Baseline and Week 6', 'description': 'The change in aspartate aminotransferase (AST) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.'}, {'measure': 'Change From Baseline in Alanine Aminotransferase', 'timeFrame': 'Baseline and Week 6', 'description': 'The change in serum alanine aminotransferase (ALT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.'}, {'measure': 'Change From Baseline in Gamma-glutamyl Transferase', 'timeFrame': 'Baseline and Week 6', 'description': 'The change in gamma-glutamyl transferase (GGT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.'}, {'measure': 'Change From Baseline in Propeptide of Type III Collagen', 'timeFrame': 'Baseline and Week 6', 'description': 'The change in serum propeptide of Type III collagen (pro-C3) from baseline at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.'}, {'measure': 'Change From Baseline in Enhanced Liver Fibrosis Score', 'timeFrame': 'Baseline and Week 6', 'description': 'The change in enhanced liver fibrosis (ELF) from baseline for each treatment group at the Week 6 visit is summarized. The ELF score combines 3 serum biomarkers (hyaluronic acid, tissue inhibitor of metalloproteinases-1 \\[TIMP-1\\] and type III procollagen \\[PIIINP\\]) which have been shown to correlate with the degree of liver fibrosis assessed by liver biopsy. Each of these markers is measured by an immunoassay and an ELF score is generated \\[ELF=2.278+0.851 ln(HA)+0.751 ln(PIIINP)+0.394 ln(TIMP-1)\\], from which a level of fibrosis severity can be determined; higher ELF scores are associated with worsening liver fibrosis. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nonalcoholic Steatohepatitis', 'NASH', 'Nonalcoholic Fatty Liver Disease'], 'conditions': ['Nonalcoholic Steatohepatitis (NASH)']}, 'descriptionModule': {'briefSummary': 'This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled study that assessed the safety efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH). Patients who meet the criteria for Study CORT118335-860 were randomized on Day 1 to receive 900 mg miricorilant, 600 mg miricorilant, or placebo for 12 weeks.\n\nDue to observations related to safety, the study was terminated prior to completion and study objectives, endpoints, and procedures were modified as specified in the protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of NASH based on a biopsy obtained within the last year OR\n* Have a diagnosis of presumed NASH based on blood tests and scans\n\nExclusion Criteria:\n\n* Have participated in another clinical trial within the last year and received active treatment for NASH\n* Have participated in another clinical trial for any other indication within the last 3 months\n* Are pregnant or lactating women\n* Have a BMI \\<18 kg/m\\^2\n* Have had liver transplantation or plan to have liver transplantation during the study\n* Have type 1 diabetes or poorly controlled type 2 diabetes.'}, 'identificationModule': {'nctId': 'NCT03823703', 'briefTitle': 'Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corcept Therapeutics'}, 'officialTitle': 'A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)', 'orgStudyIdInfo': {'id': 'CORT118335-860'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Miricorilant- 900 mg', 'description': 'Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.', 'interventionNames': ['Drug: Miricorilant']}, {'type': 'EXPERIMENTAL', 'label': 'Miricorilant- 600 mg', 'description': 'Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.', 'interventionNames': ['Drug: Miricorilant', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received 6 placebo tablets orally once daily.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Miricorilant', 'type': 'DRUG', 'otherNames': ['CORT118335'], 'description': 'Tablets taken orally', 'armGroupLabels': ['Miricorilant- 600 mg', 'Miricorilant- 900 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets', 'armGroupLabels': ['Miricorilant- 600 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site 207', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site 208', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site 209', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Site 227', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91402', 'city': 'Panorama City', 'state': 'California', 'country': 'United States', 'facility': 'Site 214', 'geoPoint': {'lat': 34.22473, 'lon': -118.44981}}, {'zip': '92704', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Site 233', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 234', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '34240', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 210', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '61434', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Site 228', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '13057', 'city': 'East Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Site 232', 'geoPoint': {'lat': 43.06534, 'lon': -76.07853}}, {'zip': '78757', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 211', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78539', 'city': 'Edinburg', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 213', 'geoPoint': {'lat': 26.30174, 'lon': -98.16334}}, {'zip': '78539', 'city': 'Edinburg', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 215', 'geoPoint': {'lat': 26.30174, 'lon': -98.16334}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 212', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Site 226', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corcept Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corcept Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}