Viewing Study NCT03912532

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Ignite Creation Date: 2025-12-24 @ 9:42 PM
Ignite Modification Date: 2025-12-30 @ 1:03 PM
Study NCT ID: NCT03912532
Status: COMPLETED
Last Update Posted: 2025-07-03
First Post: 2019-04-09
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-27', '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': 'C000710649', 'term': 'aldafermin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ngm282@ngmbio.com', 'phone': '650-243-5555', 'title': 'VP, Clinical Operations', 'organization': 'NGM Biopharmaceuticals, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30.', 'description': 'TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug.\n\nThe at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.', 'eventGroups': [{'id': 'EG000', 'title': 'Aldafermin 0.3 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 30, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Aldafermin 1.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 34, 'seriousNumAtRisk': 41, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Aldafermin 3.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 38, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants who were randomized to receive a single subcutaneous injection of placebo.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 36, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza-like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchogenic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aldafermin 0.3 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.'}, {'id': 'OG001', 'title': 'Aldafermin 1.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.'}, {'id': 'OG002', 'title': 'Aldafermin 3.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants who were randomized to receive a single subcutaneous injection of placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.24', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '0.27', 'spread': '0.07', 'groupId': 'OG002'}, {'value': '0.23', 'spread': '0.06', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.5534', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Multiple comparison procedure step', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The Multiple Comparison Procedure-Modelling (MCP-Mod) is a 2-stage procedure in which dose-response models are selected at the design stage. These candidate models are used for both dose-response testing (MCP step) and estimation (Mod step). The dose-response testing is performed using a multiple comparison method to account for the multiplicity issue associated with the multiple candidate models. Missing responses were imputed using multiple imputation under the assumption of missing at random.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 24', 'description': 'Liver biopsies were collected at baseline and Week 24 and read by a central pathologist using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) criteria. Fibrosis stages of F0, F1, F2, F3 and F4 are defined by NASH CRN criteria with F0 (minimal score) indicating no fibrosis and F4 (maximal score) indicating liver cirrhosis. Liver fibrosis response was defined as an improvement in liver fibrosis \\>=1 stage with no worsening of steatohepatitis on liver biopsy at Week 24 compared with baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Liver fibrosis response was assessed in the Intent-to-Treat Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aldafermin 0.3 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.'}, {'id': 'OG001', 'title': 'Aldafermin 1.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.'}, {'id': 'OG002', 'title': 'Aldafermin 3.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants who were randomized to receive a single subcutaneous injection of placebo.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE, Grade 1', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE, Grade 2', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE, Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE, Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE, Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any aldafermin-related TEAE', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE, not related to aldafermin', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE, possible related to aldafermin', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE, probable related to aldafermin', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE, definite related to aldafermin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any rosuvastatin-related TEAE', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE, not related to rosuvastatin', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE, possible related to rosuvastatin', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE, probable related to rosuvastatin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE, definite related to rosuvastatin', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE leading to study drug withdrawal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Any aldafermin-related TEAE leading to study drug withdrawal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any rosuvastatin-related TEAE leading to study drug withdrawal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAEs leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 24', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that commenced on or after the date and time of first study drug administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TEAEs were assessed in the Safety Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aldafermin 0.3 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.'}, {'id': 'OG001', 'title': 'Aldafermin 1.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.'}, {'id': 'OG002', 'title': 'Aldafermin 3.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants who were randomized to receive a single subcutaneous injection of placebo.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.13', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '17.40', 'spread': '6.4', 'groupId': 'OG001'}, {'value': '18.69', 'spread': '7.5', 'groupId': 'OG002'}, {'value': '17.00', 'spread': '6.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.43', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '10.62', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '7.03', 'spread': '5.7', 'groupId': 'OG002'}, {'value': '16.00', 'spread': '7.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.85', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '10.64', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '6.72', 'spread': '5.6', 'groupId': 'OG002'}, {'value': '14.01', 'spread': '6.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.30', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '15.36', 'spread': '6.5', 'groupId': 'OG001'}, {'value': '13.10', 'spread': '7.4', 'groupId': 'OG002'}, {'value': '14.27', 'spread': '7.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24, and Week 30', 'description': 'Mean percentage of liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).', 'unitOfMeasure': 'percentage of liver fat content', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean change in liver fat content was assessed in the Intent-to-Treat Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aldafermin 0.3 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.'}, {'id': 'OG001', 'title': 'Aldafermin 1.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.'}, {'id': 'OG002', 'title': 'Aldafermin 3.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants who were randomized to receive a single subcutaneous injection of placebo.'}], 'classes': [{'title': 'Change from baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.28', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-7.50', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '-11.37', 'spread': '0.84', 'groupId': 'OG002'}, {'value': '-1.49', 'spread': '0.82', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.73', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '-7.35', 'spread': '1.04', 'groupId': 'OG001'}, {'value': '-11.37', 'spread': '0.98', 'groupId': 'OG002'}, {'value': '-3.44', 'spread': '0.98', 'groupId': 'OG003'}]}]}, {'title': 'Mean change from baseline to Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.10', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '-2.95', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '-5.19', 'spread': '1.05', 'groupId': 'OG002'}, {'value': '-2.92', 'spread': '1.05', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12, Week 24, and Week 30', 'description': 'Change from baseline in liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). Negative values indicate an improvement in liver fat content.', 'unitOfMeasure': 'percentage of liver fat content', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean change from baseline in liver fat content was assessed in the Intent-to-Treat Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aldafermin 0.3 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.'}, {'id': 'OG001', 'title': 'Aldafermin 1.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.'}, {'id': 'OG002', 'title': 'Aldafermin 3.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants who were randomized to receive a single subcutaneous injection of placebo.'}], 'classes': [{'title': 'Week 12: Normalization, response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: Normalization, No response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: Decrease >=5%, Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: Decrease >=5%, No response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: Relative decrease >=30%, Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: Relative decrease >=30%, No response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: Normalization, response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: Normalization, No response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: Decrease >=5%, Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: Decrease >=5%, No response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: Relative decrease >=30%, Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: Relative decrease >=30%, No response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}, {'title': 'Week 30: Normalization, response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Week 30: Normalization, No response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'Week 30: Decrease >=5%, Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Week 30: Decrease >=5%, No response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Week 30: Relative decrease >=30%, Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Week 30: Relative decrease >=30%, No response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12, Week 24 and Week 30', 'description': 'Liver fat normalization (LFC; defined as \\<5%) and response (LFC decrease \\>=5% from baseline and LFC relative decrease \\>=30% from baseline) were assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). The responders were defined as participants with either normalization (\\<5%) or response (decrease from baseline \\>=5% or relative decrease from baseline \\>=30%).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Liver fat content normalization and response were assessed in participants with available data in the Intent-to-Treat Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aldafermin 0.3 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.'}, {'id': 'FG001', 'title': 'Aldafermin 1.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.'}, {'id': 'FG002', 'title': 'Aldafermin 3.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants who were randomized to receive a single subcutaneous injection of placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 171 participants who met all inclusion criteria and no exclusion criteria were randomized to receive treatment at 37 clinic sites in the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Aldafermin 0.3 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.'}, {'id': 'BG001', 'title': 'Aldafermin 1.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.'}, {'id': 'BG002', 'title': 'Aldafermin 3.0 mg', 'description': 'Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants who were randomized to receive a single subcutaneous injection of placebo.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '140', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '49.8', 'spread': '13.2', 'groupId': 'BG001'}, {'value': '52.7', 'spread': '11.1', 'groupId': 'BG002'}, {'value': '53.0', 'spread': '10.8', 'groupId': 'BG003'}, {'value': '52.5', 'spread': '11.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '158', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics were assessed in the Intent-to-Treat Analysis Set.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-15', 'size': 4026907, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-07T19:28', 'hasProtocol': True}, {'date': '2021-05-10', 'size': 1802849, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-07T19:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2019-04-09', 'resultsFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2019-04-09', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-16', 'studyFirstPostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis', 'timeFrame': 'Baseline up to Week 24', 'description': 'Liver biopsies were collected at baseline and Week 24 and read by a central pathologist using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) criteria. Fibrosis stages of F0, F1, F2, F3 and F4 are defined by NASH CRN criteria with F0 (minimal score) indicating no fibrosis and F4 (maximal score) indicating liver cirrhosis. Liver fibrosis response was defined as an improvement in liver fibrosis \\>=1 stage with no worsening of steatohepatitis on liver biopsy at Week 24 compared with baseline.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis', 'timeFrame': 'Baseline up to Week 24', 'description': 'Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that commenced on or after the date and time of first study drug administration.'}], 'secondaryOutcomes': [{'measure': 'Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis', 'timeFrame': 'Baseline, Week 12, Week 24, and Week 30', 'description': 'Mean percentage of liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).'}, {'measure': 'Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis', 'timeFrame': 'Baseline to Week 12, Week 24, and Week 30', 'description': 'Change from baseline in liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). Negative values indicate an improvement in liver fat content.'}, {'measure': 'Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis', 'timeFrame': 'Baseline to Week 12, Week 24 and Week 30', 'description': 'Liver fat normalization (LFC; defined as \\<5%) and response (LFC decrease \\>=5% from baseline and LFC relative decrease \\>=30% from baseline) were assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). The responders were defined as participants with either normalization (\\<5%) or response (decrease from baseline \\>=5% or relative decrease from baseline \\>=30%).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NASH - Nonalcoholic Steatohepatitis']}, 'referencesModule': {'references': [{'pmid': '35325622', 'type': 'DERIVED', 'citation': 'Harrison SA, Abdelmalek MF, Neff G, Gunn N, Guy CD, Alkhouri N, Bashir MR, Freilich B, Kohli A, Khazanchi A, Sheikh MY, Leibowitz M, Rinella ME, Siddiqui MS, Kipnes M, Moussa SE, Younes ZH, Bansal M, Baum SJ, Borg B, Ruane PJ, Thuluvath PJ, Gottwald M, Khan M, Chen C, Melchor-Khan L, Chang W, DePaoli AM, Ling L, Lieu HD. Aldafermin in patients with non-alcoholic steatohepatitis (ALPINE 2/3): a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2022 Jul;7(7):603-616. doi: 10.1016/S2468-1253(22)00017-6. Epub 2022 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed NASH diagnosis as defined by the NASH CRN\n2. Total liver fat content of ≥ 8% as measured by MRI-PDFF\n\nExclusion Criteria:\n\n1. Clinically significant acute or chronic liver disease of an etiology other than NASH\n2. Evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis\n3. History or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters\n4. Prior or pending liver transplantation\n\nOther protocol-defined inclusion/exclusion criteria could apply.'}, 'identificationModule': {'nctId': 'NCT03912532', 'briefTitle': 'Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'NGM Biopharmaceuticals, Inc'}, 'officialTitle': 'A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of NGM282 Administered for 24 Weeks for the Treatment of Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)', 'orgStudyIdInfo': {'id': '18-0108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NGM282 Dose 1', 'description': 'Administered by subcutaneous injection', 'interventionNames': ['Biological: NGM282']}, {'type': 'EXPERIMENTAL', 'label': 'NGM282 Dose 2', 'description': 'Administered by subcutaneous injection', 'interventionNames': ['Biological: NGM282']}, {'type': 'EXPERIMENTAL', 'label': 'NGM282 Dose 3', 'description': 'Administered by subcutaneous injection', 'interventionNames': ['Biological: NGM282']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administered by subcutaneous injection', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'NGM282', 'type': 'BIOLOGICAL', 'description': 'NGM282', 'armGroupLabels': ['NGM282 Dose 1', 'NGM282 Dose 2', 'NGM282 Dose 3']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo for NGM282', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'NGM Clinical Study Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 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