Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT02704403
Status:
TERMINATED
Last Update Posted:
2022-03-23
First Post:
2016-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585906', 'term': '2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrial@genfit.com', 'phone': '+01 6179536469', 'title': 'Carol Addy, MD MMSc', 'organization': 'GENFIT'}, 'certainAgreement': {'otherDetails': 'All materials, information (oral or written) and unpublished documentation provided to the Investigators (or any company/institution acting on their behalf) are the exclusive property of the Sponsor and may not be given or disclosed, either in part or in whole, by the Investigator or by any person under his/her authority to any third party without the prior express consent of the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was prematurely terminated based upon limited efficacy at time of the interim analysis, not due to safety concerns, and the conclusion that there would be limited benefit for participants to continue in the trial. Therefore, the results for efficacy endpoints other than the primary and key secondary endpoints are not presented in the disclosure of these results.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days.', 'description': 'The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.', 'eventGroups': [{'id': 'EG000', 'title': '120 mg Elafibranor', 'description': 'Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water', 'otherNumAtRisk': 1433, 'deathsNumAtRisk': 1437, 'otherNumAffected': 1227, 'seriousNumAtRisk': 1433, 'deathsNumAffected': 6, 'seriousNumAffected': 190}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water', 'otherNumAtRisk': 717, 'deathsNumAtRisk': 720, 'otherNumAffected': 601, 'seriousNumAtRisk': 717, 'deathsNumAffected': 3, 'seriousNumAffected': 95}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 171, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 82, 'numAffected': 68}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 158, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 51, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 105, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 49, 'numAffected': 47}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 94, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 57, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 111, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 54, 'numAffected': 49}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 236, 'numAffected': 145}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 134, 'numAffected': 77}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 186, 'numAffected': 134}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 61, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 127, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 68, 'numAffected': 54}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 132, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 55, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 111, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 36, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 96, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 53, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 109, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 62, 'numAffected': 58}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 202, 'numAffected': 160}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 110, 'numAffected': 81}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 144, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 62, 'numAffected': 60}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 77, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 27, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 114, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 46, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 99, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 47, 'numAffected': 40}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 99, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 42, 'numAffected': 39}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}], 'seriousEvents': [{'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiac asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Prinzmetal angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': "Pituitary-dependent Cushing's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Primary hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Optic ischaemic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Urogenital fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Adnexa uteri mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pickwickian syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Dermatitis bullous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1433, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 717, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '717', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg Elafibranor', 'description': 'Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water'}], 'classes': [{'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0659', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.043', 'ciLowerLimit': '-0.003', 'ciUpperLimit': '0.090', 'groupDescription': 'The null hypothesis was that there was no difference in response rates between the elafibranor and placebo treatment groups. The alternative hypothesis was that there was a difference in the response rates between the elafibranor and placebo treatment groups.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'test is 2-sided, alpha=0.01'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measurement at 72 weeks', 'description': 'To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants with fibrosis by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving NASH resolution without worsening of fibrosis. This outcome measure is for the surrogate endpoint analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.'}, {'type': 'PRIMARY', 'title': 'Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'OG000'}, {'value': '720', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg Elafibranor', 'description': 'Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'Events', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Censored', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No events or not censored', 'measurements': [{'value': '1437', 'groupId': 'OG000'}, {'value': '720', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'title': 'Events', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Censored', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'No events or not censored', 'measurements': [{'value': '1388', 'groupId': 'OG000'}, {'value': '693', 'groupId': 'OG001'}]}]}, {'title': '12 months', 'categories': [{'title': 'Events', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Censored', 'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}, {'title': 'No events or not censored', 'measurements': [{'value': '1277', 'groupId': 'OG000'}, {'value': '637', 'groupId': 'OG001'}]}]}, {'title': '18 months', 'categories': [{'title': 'Events', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Censored', 'measurements': [{'value': '374', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}, {'title': 'No events or not censored', 'measurements': [{'value': '1010', 'groupId': 'OG000'}, {'value': '497', 'groupId': 'OG001'}]}]}, {'title': '24 months', 'categories': [{'title': 'Events', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Censored', 'measurements': [{'value': '609', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}, {'title': 'No events or not censored', 'measurements': [{'value': '772', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}]}, {'title': '30 months', 'categories': [{'title': 'Events', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Censored', 'measurements': [{'value': '778', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}, {'title': 'No events or not censored', 'measurements': [{'value': '602', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}]}, {'title': '36 months', 'categories': [{'title': 'Events', 'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Censored', 'measurements': [{'value': '1049', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}, {'title': 'No events or not censored', 'measurements': [{'value': '328', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}]}, {'title': '42 months', 'categories': [{'title': 'Events', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Censored', 'measurements': [{'value': '1293', 'groupId': 'OG000'}, {'value': '652', 'groupId': 'OG001'}]}, {'title': 'No events or not censored', 'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': '48 months', 'categories': [{'title': 'Events', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Censored', 'measurements': [{'value': '1374', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}, {'title': 'No events or not censored', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '54 months', 'categories': [{'title': 'Events', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Censored', 'measurements': [{'value': '1376', 'groupId': 'OG000'}, {'value': '688', 'groupId': 'OG001'}]}, {'title': 'No events or not censored', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.950', 'ciLowerLimit': '0.619', 'ciUpperLimit': '1.457', 'estimateComment': 'No formal test due to the early termination of the study.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant)', 'description': 'Composite long-term outcome measured by the number of participants with the onset of any of the adjudicated events, composed of death due to any cause, histological liver cirrhosis, and the full list of portal hypertension/cirrhosis related events as follows: liver transplantation; model for end stage liver disease (MELD) score greater than or equal to 15 for participants with baseline score less than or equal to 12, and onset of variceal bleeding requiring hospitalization, hepatic encephalopathy with West Haven/Conn score greater than or equal to 2 and requiring hospitalization, spontaneous bacterial peritonitis, and ascites requiring treatment. The MELD scale ranges from 6 to 40, showing how much a participant needs a liver transplant: higher number is more urgent. The West Haven/Conn scale is 5-point (0 to 4) grading severity of hepatic encephalopathy: higher score means worse hepatic encephalopathy. This outcome measure is for the long-term endpoint analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Intent-to-Treat Set: All randomized participants. Participants were analyzed according to their randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '717', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg Elafibranor', 'description': 'Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water'}], 'classes': [{'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measurements at 72 weeks', 'description': 'To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving improvement of liver fibrosis of at least 1 stage according to NASH Clinical Research Network (CRN) Scoring. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Set: For the purpose of analysis sets aligned with efficacy summaries, a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early were considered.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg Elafibranor', 'description': 'Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '-0.19', 'upperLimit': '0.25'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.24', 'upperLimit': '0.23'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measurements after 72 weeks of treatment and up to study termination', 'description': 'Hemoglobin A1c (HbA1c) were tested at Week 72. Changes from baseline in HbA1c at Week 72 were evaluated. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early. Number of participants with diabetes who had available data at Week 72 are presented.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of High-density Lipoprotein (HDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '629', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg Elafibranor', 'description': 'Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.036', 'groupId': 'OG000', 'lowerLimit': '-0.050', 'upperLimit': '-0.021'}, {'value': '-0.052', 'groupId': 'OG001', 'lowerLimit': '-0.073', 'upperLimit': '-0.032'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measurements after 72 weeks of treatment and up to study termination', 'description': 'High-density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Low-density Lipoprotein (LDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg Elafibranor', 'description': 'Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.250', 'groupId': 'OG000', 'lowerLimit': '-0.295', 'upperLimit': '-0.204'}, {'value': '-0.217', 'groupId': 'OG001', 'lowerLimit': '-0.282', 'upperLimit': '-0.151'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measurements after 72 weeks of treatment and up to study termination', 'description': 'Low-density lipoprotein (LDL) cholesterol was tested at Week 72. Changes from baseline in LDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Homeostatic Model Assessment-IR (HOMA-IR) After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo in Non-diabetic Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg Elafibranor', 'description': 'Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.789', 'groupId': 'OG000', 'lowerLimit': '-2.979', 'upperLimit': '1.402'}, {'value': '-0.930', 'groupId': 'OG001', 'lowerLimit': '-3.347', 'upperLimit': '1.486'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measurements after 72 weeks of treatment and up to study termination', 'description': 'Homeostatic model assessment-IR (HOMA-IR) was tested at Week 72. Changes from baseline in HOMA-IR were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.', 'unitOfMeasure': 'index', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Non-high Density Lipoprotein Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg Elafibranor', 'description': 'Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.445', 'groupId': 'OG000', 'lowerLimit': '-0.499', 'upperLimit': '-0.392'}, {'value': '-0.271', 'groupId': 'OG001', 'lowerLimit': '-0.348', 'upperLimit': '-0.195'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measurements after 72 weeks of treatment and up to study termination', 'description': 'Non-high density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in non-HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Triglycerides After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '636', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '120 mg Elafibranor', 'description': 'Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.466', 'groupId': 'OG000', 'lowerLimit': '-0.537', 'upperLimit': '-0.395'}, {'value': '-0.148', 'groupId': 'OG001', 'lowerLimit': '-0.249', 'upperLimit': '-0.046'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Measurements after 72 weeks of treatment and up to study termination', 'description': 'Triglycerides was tested at Week 72. Changes from baseline in triglycerides were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '120 mg Elafibranor', 'description': 'Coated 120mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1437'}, {'groupId': 'FG001', 'numSubjects': '720'}]}, {'type': 'Full Intent-to-Treat Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1437'}, {'groupId': 'FG001', 'numSubjects': '720'}]}, {'type': 'Full Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1433'}, {'groupId': 'FG001', 'numSubjects': '717'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1437'}, {'groupId': 'FG001', 'numSubjects': '720'}]}], 'dropWithdraws': [{'type': 'Randomized and not treated (due to non-compliance with protocol)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Administrative reasons by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1251'}, {'groupId': 'FG001', 'numSubjects': '616'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Endpoint event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Follow-up not possible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The version 3 protocol for Brazil is included in the uploaded documents as it was part of the pre-specified plan, but this country was not used as part of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '120 mg Elafibranor', 'description': 'Coated 120mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.0', 'spread': '11.78', 'groupId': 'BG000'}, {'value': '54.4', 'spread': '11.63', 'groupId': 'BG001'}, {'value': '54.1', 'spread': '11.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '622', 'groupId': 'BG000'}, {'value': '308', 'groupId': 'BG001'}, {'value': '930', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '815', 'groupId': 'BG000'}, {'value': '412', 'groupId': 'BG001'}, {'value': '1227', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '336', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '513', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1089', 'groupId': 'BG000'}, {'value': '532', 'groupId': 'BG001'}, {'value': '1621', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1234', 'groupId': 'BG000'}, {'value': '614', 'groupId': 'BG001'}, {'value': '1848', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '98.0', 'spread': '21.90', 'groupId': 'BG000'}, {'value': '96.3', 'spread': '20.84', 'groupId': 'BG001'}, {'value': '97.4', 'spread': '21.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1436', 'groupId': 'BG000'}, {'value': '718', 'groupId': 'BG001'}, {'value': '2154', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '169.1', 'spread': '10.48', 'groupId': 'BG000'}, {'value': '168.8', 'spread': '10.23', 'groupId': 'BG001'}, {'value': '169.0', 'spread': '10.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants with data available are presented'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1436', 'groupId': 'BG000'}, {'value': '718', 'groupId': 'BG001'}, {'value': '2154', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34.1', 'spread': '6.13', 'groupId': 'BG000'}, {'value': '33.6', 'spread': '5.77', 'groupId': 'BG001'}, {'value': '33.9', 'spread': '6.01', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants with data available are presented'}, {'title': 'Waist Circumference', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1431', 'groupId': 'BG000'}, {'value': '719', 'groupId': 'BG001'}, {'value': '2150', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '111.9', 'spread': '14.19', 'groupId': 'BG000'}, {'value': '110.4', 'spread': '13.48', 'groupId': 'BG001'}, {'value': '111.4', 'spread': '13.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants with data available are presented'}, {'title': 'Child Bearing Potential', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '516', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '778', 'groupId': 'BG002'}]}]}, {'title': 'Not applicable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '815', 'groupId': 'BG000'}, {'value': '412', 'groupId': 'BG001'}, {'value': '1227', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type 2 Diabetes', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '699', 'groupId': 'BG000'}, {'value': '351', 'groupId': 'BG001'}, {'value': '1050', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '738', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '1107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fibrosis Stage', 'classes': [{'title': 'F1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}, {'title': 'F2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '603', 'groupId': 'BG000'}, {'value': '302', 'groupId': 'BG001'}, {'value': '905', 'groupId': 'BG002'}]}]}, {'title': 'F3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '699', 'groupId': 'BG000'}, {'value': '349', 'groupId': 'BG001'}, {'value': '1048', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'There are five stages of fibrosis with F0: no scarring (no fibrosis); F1: minimal scarring; F2: scarring has occurred and extends outside the liver area (significant fibrosis); F3: fibrosis spreading and forming bridges with other fibrotic liver areas (severe fibrosis); F4: cirrhosis or advanced scarring.', 'unitOfMeasure': 'Participants'}, {'title': 'Non-alcoholic fatty liver disease Activity Score Grouped Severity Score (categorical)', 'classes': [{'title': 'Moderate (4-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '663', 'groupId': 'BG000'}, {'value': '317', 'groupId': 'BG001'}, {'value': '980', 'groupId': 'BG002'}]}]}, {'title': 'Severe (greater than or equal to 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '774', 'groupId': 'BG000'}, {'value': '402', 'groupId': 'BG001'}, {'value': '1176', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Non-alcoholic fatty liver disease Activity Score Severity Score (NAS score) is a measure of grade and is the sum of numerical scores applied to steatosis (0-3), hepatocellular ballooning (0-2), and lobular inflammation (0-3). Accordingly, the NAS ranges from 0 to 8.\n\nNAS scores of 0-2 are considered not diagnostic of NASH, NAS scores of 3-4 are considered as NASH diagnostic, borderline, or positive for NASH.\n\nNAS Scores of 5-8 occurred in cases that are largely considered diagnostic of NASH', 'unitOfMeasure': 'Participants'}, {'title': 'Non-alcoholic fatty liver disease Activity Score Severity Score (categorical)', 'classes': [{'title': '4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}, {'title': '5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '470', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '693', 'groupId': 'BG002'}]}]}, {'title': '6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '453', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '678', 'groupId': 'BG002'}]}]}, {'title': '7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '425', 'groupId': 'BG002'}]}]}, {'title': '8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Non-alcoholic fatty liver disease Activity Score Severity Score (NAS score) is a measure of grade and is the sum of numerical scores applied to steatosis (0-3), hepatocellular ballooning (0-2), and lobular inflammation (0-3). Accordingly, the NAS ranges from 0 to 8.\n\nNAS scores of 0-2 are considered not diagnostic of NASH, NAS scores of 3-4 are considered as NASH diagnostic, borderline, or positive for NASH.\n\nNAS Scores of 5-8 occurred in cases that are largely considered diagnostic of NASH', 'unitOfMeasure': 'Participants'}, {'title': 'Model For End-Stage Liver Disease Score (categorical)', 'classes': [{'title': 'Less than 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1426', 'groupId': 'BG000'}, {'value': '715', 'groupId': 'BG001'}, {'value': '2141', 'groupId': 'BG002'}]}]}, {'title': 'Greater than or equal to 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1437', 'groupId': 'BG000'}, {'value': '720', 'groupId': 'BG001'}, {'value': '2157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Model for End-Stage Liver Disease (MELD) is a scoring system for assessing the severity of chronic liver disease. the score is useful both in predicting short-term survival in groups of patients on the waiting list for liver transplantation as well as the risk of postoperative mortality. Patients are assigned a score from 6 to 40, with 40 representing the greatest severity of liver disease, and a high risk of death in the ensuing three months without transplantation. Patients with score \\< 15 are deferred of liver transplantation.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-23', 'size': 28757563, 'label': 'Study Protocol: Local Protocols', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-01-05T03:32', 'hasProtocol': True}, {'date': '2020-04-20', 'size': 14891467, 'label': 'Study Protocol: General Protocols', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-01-05T04:01', 'hasProtocol': True}, {'date': '2020-11-23', 'size': 20027144, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-22T07:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2157}}, 'statusModule': {'whyStopped': 'Study did not meet the predefined primary surrogate efficacy endpoint, no safety issues identified', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-25', 'studyFirstSubmitDate': '2016-02-16', 'resultsFirstSubmitDate': '2022-01-07', 'studyFirstSubmitQcDate': '2016-03-04', 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-25', 'studyFirstPostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis', 'timeFrame': 'Measurement at 72 weeks', 'description': 'To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants with fibrosis by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving NASH resolution without worsening of fibrosis. This outcome measure is for the surrogate endpoint analysis.'}, {'measure': 'Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes', 'timeFrame': 'From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant)', 'description': 'Composite long-term outcome measured by the number of participants with the onset of any of the adjudicated events, composed of death due to any cause, histological liver cirrhosis, and the full list of portal hypertension/cirrhosis related events as follows: liver transplantation; model for end stage liver disease (MELD) score greater than or equal to 15 for participants with baseline score less than or equal to 12, and onset of variceal bleeding requiring hospitalization, hepatic encephalopathy with West Haven/Conn score greater than or equal to 2 and requiring hospitalization, spontaneous bacterial peritonitis, and ascites requiring treatment. The MELD scale ranges from 6 to 40, showing how much a participant needs a liver transplant: higher number is more urgent. The West Haven/Conn scale is 5-point (0 to 4) grading severity of hepatic encephalopathy: higher score means worse hepatic encephalopathy. This outcome measure is for the long-term endpoint analysis.'}], 'secondaryOutcomes': [{'measure': 'Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage', 'timeFrame': 'Measurements at 72 weeks', 'description': 'To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving improvement of liver fibrosis of at least 1 stage according to NASH Clinical Research Network (CRN) Scoring. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.'}, {'measure': 'Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo', 'timeFrame': 'Measurements after 72 weeks of treatment and up to study termination', 'description': 'Hemoglobin A1c (HbA1c) were tested at Week 72. Changes from baseline in HbA1c at Week 72 were evaluated. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.'}, {'measure': 'Change From Baseline of High-density Lipoprotein (HDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo', 'timeFrame': 'Measurements after 72 weeks of treatment and up to study termination', 'description': 'High-density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.'}, {'measure': 'Change From Baseline of Low-density Lipoprotein (LDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo', 'timeFrame': 'Measurements after 72 weeks of treatment and up to study termination', 'description': 'Low-density lipoprotein (LDL) cholesterol was tested at Week 72. Changes from baseline in LDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.'}, {'measure': 'Change From Baseline of Homeostatic Model Assessment-IR (HOMA-IR) After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo in Non-diabetic Participants', 'timeFrame': 'Measurements after 72 weeks of treatment and up to study termination', 'description': 'Homeostatic model assessment-IR (HOMA-IR) was tested at Week 72. Changes from baseline in HOMA-IR were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.'}, {'measure': 'Change From Baseline of Non-high Density Lipoprotein Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo', 'timeFrame': 'Measurements after 72 weeks of treatment and up to study termination', 'description': 'Non-high density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in non-HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.'}, {'measure': 'Change From Baseline of Triglycerides After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo', 'timeFrame': 'Measurements after 72 weeks of treatment and up to study termination', 'description': 'Triglycerides was tested at Week 72. Changes from baseline in triglycerides were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['Elafibranor', 'NASH', 'Nonalcoholic steatohepatitis', 'Fatty liver disease', 'Fibrosis'], 'conditions': ['Nonalcoholic Steatohepatitis (NASH) With Fibrosis']}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males or females aged from 18 to 75 years inclusive at first screening visit.\n2. Must provide signed written informed consent and agree to comply with the study protocol.\n3. Females participating in this study must be of nonchildbearing potential or using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment, as described below:\n\n 1. Cessation of menses for at least 12 months due to ovarian failure,\n 2. Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medically documented ovarian failure\n 3. If requested by local IRB regulations and/or National laws, sexual abstinence may be considered adequate (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)\n 4. Using a highly effective nonhormonal method of contraception (bilateral tubal occlusion, vasectomized partner, or intra-uterine device)\n 5. Double contraception with barrier AND highly effective hormonal method of contraception (oral, intravaginal, or transdermal combined estrogen and progestogen hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; or intrauterine hormone-releasing system). The hormonal contraception must be started at least 1 month prior to Randomization.\n4. Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to randomization or during the screening period) with at least 1 in each component of the NAS score (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3).\n5. NAS score ≥4.\n6. Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.\n7. Stable dose of vitamin E, polyunsaturated fatty acids, or ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy\n8. For participants with type 2 diabetes, glycemia must be controlled. If glycemia is controlled by antidiabetic drugs, change in anti-diabetic therapy must follow these requirements:\n\n 1. No qualitative change 6 months prior to diagnostic liver biopsy up to Randomization (i.e., implementation of a new anti-diabetic therapy) for participants treated with metformin, gliptins, sulfonylureas, sodium/glucose cotransporter (SGLT) 2 inhibitors, glucagon-like peptide (GLP)-1 agonists, or insulin. Dose changes of these medications are allowed in the 6 months prior to diagnostic liver biopsy, except for GLP-1 agonists, which must remain on stable dose in the 6 months prior to diagnostic liver biopsy.\n 2. No implementation of GLP-1 agonists and SGLT2 inhibitors up to 72 weeks of treatment (Visit 7).\n\nInitiation of any other antidiabetic drugs is allowed after Randomization based on treating physicians' judgment, except for glitazones which are prohibited 6 months prior to diagnostic liver biopsy until the end of treatment.\n\nExclusion Criteria:\n\n1. Known heart failure (Grade I to IV of New York Heart Association classification).\n2. History of efficient bariatric surgery within 5 years prior to screening.\n3. Uncontrolled hypertension during the Screening Period despite optimal antihypertensive therapy\n4. Type 1 diabetes participants .\n5. Participants with decompensated diabetes (HbA1c\\>9%).\n6. Participants with a history of clinically significant acute cardiac event within 6 months prior to screening\n7. Weight loss of more than 5% within 6 months prior to randomization\n8. Compensated and decompensated cirrhosis\n9. Current or recent history (\\<5 years) of significant alcohol consumption\n10. Pregnant or lactating females or females planning to become pregnant during the study period.\n11. Other well documented causes of chronic liver disease according to standard diagnostic procedures\n12. Participants with previous exposure to Elafibranor\n13. Prohibited concomitant medication\n14. Any medical conditions that may diminish life expectancy to less than 2 years including known cancers.\n15. Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric disease.\n16. Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.\n17. Participants with biological criteria exclusion as per effective protocol"}, 'identificationModule': {'nctId': 'NCT02704403', 'acronym': 'RESOLVE-IT', 'briefTitle': 'Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genfit'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis', 'orgStudyIdInfo': {'id': 'GFT505-315-1'}, 'secondaryIdInfos': [{'id': '2015-005385-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '120 mg Elafibranor', 'description': 'Coated tablets dosed at 120mg Elafibranor; oral administration; one tablet per day before breakfast with a glass of water', 'interventionNames': ['Drug: Elafibranor']}, {'type': 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