Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT03987451
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2019-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-08', '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': 'C000591245', 'term': 'semaglutide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178', 'title': 'Clinical Reporting Office (2834)', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From week 0 to week 55. Results are based on the safety analysis set which included all participants who received at least one dose of randomised treatment.', 'description': 'All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during on-treatment period. On-treatment period which started on the date of first administration of trial product and ended on the date of whatever comes first of: a) last dose of trial product + 49 days (7 half-lives of semaglutide), b) follow-up visit (week 55), or c) end of the in-trial period (week 55).', 'eventGroups': [{'id': 'EG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 38, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 15, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 19, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 34, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Spinal claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With At Least One Stage of Liver Fibrosis Improvement With No Worsening of Non-Alcoholic Steatohepatitis (NASH) After 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}, {'value': '29.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0867', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.06', 'ciUpperLimit': '1.24', 'groupDescription': 'The common odds ratio between semaglutide and placebo adjusting for baseline diabetes was estimated along with exact 95% confidence interval based on conditioning on the marginal 2×2 tables.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'NASH resolution defined by NASH clinical research network (CRN) as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, higher scores indicating more severe hepatocellular ballooning/lobular inflammation. Worsening of NASH defined by NASH CRN as increase of at least 1 stage of either lobular inflammation, hepatocyte ballooning or steatosis. Worsening of fibrosis defined by increase in fibrosis at least 1 stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Liver Fat Content Measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'spread': '63.38', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '34.46', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in liver fat content (measured as percentage) from baseline to week 48 is presented as ratio to baseline. Liver fat content was assessed via MRI-PDFF technique and results were measured in percentage. MRI-PDFF utilized a gradient echo sequence with low flip angle to minimize T1 bias, corrected T2\\* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of liver fat content', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Liver Stiffness Measured by Magnetic Resonance Elastography (MRE)-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'spread': '22.24', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '28.51', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in Liver Stiffness from baseline to week 48 is presented as ratio to baseline. Liver stiffness was measured in kilopascal using MRE. MRE is a technology that uses MRI imaging with low-frequency vibrations to create a visual map (elastogram) that shows stiffness of the liver. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of liver stiffness', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With NASH Resolution After 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000'}, {'value': '20.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fibrosis-4 Score-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '30.7', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '38.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in fibrosis-4 score from baseline to week 48 is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and age that was calculated using formula: Fibrosis-4 = (Age \\[years\\] x AST \\[units per liter (U/L)\\]) / (platelets \\[10\\^9 cells/L\\] x (square root of ALT \\[U/L\\])). A Fibrosis-4 index of \\< 1.45 indicated no or moderate fibrosis and an index of \\> 3.25 indicated extensive fibrosis/cirrhosis. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of fibrosis-4 score', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Improvement', 'categories': [{'measurements': [{'value': '61.7', 'groupId': 'OG000'}, {'value': '58.3', 'groupId': 'OG001'}]}]}, {'title': 'Worsening', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '20.8', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 48 or missing data is presented. Worsening was defined as an increase of at least 1 in the NAS; Improvement was defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS and missing refers to participants with missing outcomes for NAS from baseline to week 48. NAS was calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change in The Fibrosis Stage According to The Kleiner Fibrosis Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Improvement', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Worsening', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '72.3', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 48 or missing data is presented. The degree of fibrosis was described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change in Hepatocyte Ballooning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Improvement', 'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Worsening', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000'}, {'value': '54.2', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 48 or missing data is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change in Lobular Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Improvement', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'Worsening', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000'}, {'value': '45.8', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 48 or missing data is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change in Steatosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Improvement', 'categories': [{'measurements': [{'value': '44.7', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Worsening', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000'}, {'value': '45.8', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 48 or missing data is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change in The Steatosis-Activity-Fibrosis (SAF) Activity Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Improvement', 'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Worsening', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 48 or missing data is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change in The Ishak Fibrosis Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Improvement', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'Worsening', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000'}, {'value': '45.8', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had improved, worsened, or had no change in the Ishak fibrosis score from baseline to week 48 or missing data is presented. Ishak fibrosis score was assessed on a scale of 0-6, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hepatic Collagen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in hepatic collagen from baseline to week 48 was analysed. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of hepatic collagen', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in Fibrosis Stage According to The Kleiner Fibrosis Classification (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '72.3', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in Kleiner fibrosis classification. The degree of fibrosis was described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in Kleiner fibrosis classification; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal)."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in Hepatocyte Ballooning (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in hepatocyte ballooning clinical research network (CRN) score. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in hepatocyte ballooning; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal)."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in Lobular Inflammation (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}, {'value': '58.3', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in lobular inflammation CRN score. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in lobular inflammation; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal)."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in Steatosis (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '44.7', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in steatosis CRN score. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in steatosis; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal)."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in NAS (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '61.7', 'groupId': 'OG000'}, {'value': '58.3', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in NAS. NAS was calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in NAS; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal)."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in SAF Activity Component Score (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000'}, {'value': '45.8', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in SAF score. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in SAF score; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal)."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in Ishak Fibrosis Score (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000'}, {'value': '58.3', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in Ishak fibrosis score. Ishak fibrosis score was assessed on a scale of 0-6, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in Ishak fibrosis score; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal)."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.6', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '5.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in body weight from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Relative Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.83', 'spread': '7.44', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '7.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Relative change in body weight (measured as kg) from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.3', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in waist circumference from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in BMI from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Kilograms per meter square', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Weight Loss of >= 5% of Baseline Body Weight at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000'}, {'value': '25.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Percentage of participants with weight loss of greater than or equal to (≥) 5% of baseline body weight at 48 weeks is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Weight Loss of >= 10% of Baseline Body Weight at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Percentage of participants with weight loss of ≥ 10% of baseline body weight at 48 weeks is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in HbA1c from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Percentage of HbA1C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.20', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '2.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in FPG from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'millimoles per liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting C-peptide-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.95', 'spread': '47.08', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '45.73', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in fasting C-peptide \\[measured as nanomoles per litre (nmol/L)\\] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of fasting C-peptide', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic And Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'title': 'Change From Baseline in Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '17.1', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline in Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '0.4', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in systolic and diastolic blood pressure from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'millimeter of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Cholesterol-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.98', 'spread': '11.86', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '17.61', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in total cholesterol (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of total cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'spread': '17.88', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '30.07', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in LDL cholesterol (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of LDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'spread': '12.83', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '16.30', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in HDL cholesterol (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of HDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'spread': '28.37', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '28.09', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in VLDL cholesterol (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of VLDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Triglycerides-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'spread': '28.40', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '28.08', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in triglycerides (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of triglycerides', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Free Fatty Acids (FFA)-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'spread': '75.99', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '77.70', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in free fatty acids (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of FFA', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High-Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '107.66', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '70.38', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in hsCRP (measured as milligrams per liter) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of hsCRP', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alanine Aminotransferase (ALT)-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '58.1', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '32.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in ALT (measured as units per liter) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of ALT', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Aspartate Aminotransferase (AST)-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '47.8', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '29.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in AST (measured as units per liter) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of AST', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Gamma-Glutamyl Transferase (GGT)-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '40.9', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '24.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in GGT (measured as units per liter) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of GGT', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Albumin-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in albumin \\[measured as grams per deciliter (g/dL)\\] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of albumin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Thrombocytes-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '14.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in thrombocytes \\[measured as 10\\^9 cells per liter\\] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of thrombocytes', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Normalized Ratio (INR)-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '5.59', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '25.07', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in INR from baseline to week 48 is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of INR', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Direct Bilirubin-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '33.7', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '24.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in direct bilirubin \\[measured as micromoles per liter (umol/L)\\] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of direct bilirubin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Bilirubin-Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '34.5', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '24.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in total bilirubin \\[measured as umol/L\\] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.', 'unitOfMeasure': 'Ratio of total bilirubin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to week 55', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. Outcome measure was evaluated based on data from on-treatment period which started on the date of first administration of trial product and ended on the date of whatever comes first of: a) last dose of trial product + 49 days (7 half-lives of semaglutide), b) follow-up visit (week 55), or c) end of the in-trial period.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants that received at least one dose of randomised treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-Emergent Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to week 55', 'description': 'Hypoglycaemic episode (blood glucose less than or equal to (\\<=) 3.9 mmol/L \\[70 milligrams per decilitre (mg/dL)\\] Or greater than (\\>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. Outcome measure was evaluated based on data from on-treatment period which started on the date of first administration of trial product and ended on the date of whatever comes first of: a) last dose of trial product + 49 days (7 half-lives of semaglutide), b) follow-up visit (week 55), or c) end of the in-trial period.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants that received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'spread': '11', 'groupId': 'OG000'}, {'value': '2', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in pulse from baseline to week 48 is presented. Outcome measure was evaluated based on data from on-treatment period which started on the date of first administration of trial product and ended on the date of whatever comes first of: a) last dose of trial product + 49 days (7 half-lives of semaglutide), b) follow-up visit (week 55), or c) end of the in-trial period.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants that received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The trial was conducted at 38 sites in 5 countries as follows (number of sites that screened subjects/ number of sites that randomised subjects): United States (24/19); United Kingdom (4/3); Germany (3/2); France (5/3); Spain (2/2).', 'preAssignmentDetails': 'Participants were randomised in a 2:1 ratio to receive once-weekly either semaglutide or placebo subcutaneously as an adjunct to a reduced-calorie diet and increased physical activity.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Semaglutide 2.4 mg', 'description': 'Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': '65<= to <75 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-21', 'size': 16552174, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-10T07:38', 'hasProtocol': True}, {'date': '2021-06-17', 'size': 537662, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-10T07:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sponsor staff involved in the clinical trial is masked according to company standard procedures.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'dispFirstSubmitDate': '2022-04-19', 'completionDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2019-06-12', 'resultsFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2019-06-12', 'dispFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-28', 'studyFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With At Least One Stage of Liver Fibrosis Improvement With No Worsening of Non-Alcoholic Steatohepatitis (NASH) After 48 Weeks', 'timeFrame': 'Week 48', 'description': 'NASH resolution defined by NASH clinical research network (CRN) as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, higher scores indicating more severe hepatocellular ballooning/lobular inflammation. Worsening of NASH defined by NASH CRN as increase of at least 1 stage of either lobular inflammation, hepatocyte ballooning or steatosis. Worsening of fibrosis defined by increase in fibrosis at least 1 stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Liver Fat Content Measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in liver fat content (measured as percentage) from baseline to week 48 is presented as ratio to baseline. Liver fat content was assessed via MRI-PDFF technique and results were measured in percentage. MRI-PDFF utilized a gradient echo sequence with low flip angle to minimize T1 bias, corrected T2\\* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Liver Stiffness Measured by Magnetic Resonance Elastography (MRE)-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in Liver Stiffness from baseline to week 48 is presented as ratio to baseline. Liver stiffness was measured in kilopascal using MRE. MRE is a technology that uses MRI imaging with low-frequency vibrations to create a visual map (elastogram) that shows stiffness of the liver. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With NASH Resolution After 48 Weeks', 'timeFrame': 'Week 48', 'description': 'NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Fibrosis-4 Score-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in fibrosis-4 score from baseline to week 48 is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and age that was calculated using formula: Fibrosis-4 = (Age \\[years\\] x AST \\[units per liter (U/L)\\]) / (platelets \\[10\\^9 cells/L\\] x (square root of ALT \\[U/L\\])). A Fibrosis-4 index of \\< 1.45 indicated no or moderate fibrosis and an index of \\> 3.25 indicated extensive fibrosis/cirrhosis. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 48 or missing data is presented. Worsening was defined as an increase of at least 1 in the NAS; Improvement was defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS and missing refers to participants with missing outcomes for NAS from baseline to week 48. NAS was calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Change in The Fibrosis Stage According to The Kleiner Fibrosis Classification', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 48 or missing data is presented. The degree of fibrosis was described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Change in Hepatocyte Ballooning', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 48 or missing data is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Change in Lobular Inflammation', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 48 or missing data is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Change in Steatosis', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 48 or missing data is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Change in The Steatosis-Activity-Fibrosis (SAF) Activity Component Score', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 48 or missing data is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Change in The Ishak Fibrosis Score', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Percentage of participants who had improved, worsened, or had no change in the Ishak fibrosis score from baseline to week 48 or missing data is presented. Ishak fibrosis score was assessed on a scale of 0-6, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Hepatic Collagen', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in hepatic collagen from baseline to week 48 was analysed. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Improvement in Fibrosis Stage According to The Kleiner Fibrosis Classification (Yes/No)', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in Kleiner fibrosis classification. The degree of fibrosis was described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Improvement in Hepatocyte Ballooning (Yes/No)', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in hepatocyte ballooning clinical research network (CRN) score. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Improvement in Lobular Inflammation (Yes/No)', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in lobular inflammation CRN score. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Improvement in Steatosis (Yes/No)', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in steatosis CRN score. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Improvement in NAS (Yes/No)', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in NAS. NAS was calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Improvement in SAF Activity Component Score (Yes/No)', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in SAF score. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Improvement in Ishak Fibrosis Score (Yes/No)', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Improvement is defined as at least one stage decrease from baseline to week 48 in Ishak fibrosis score. Ishak fibrosis score was assessed on a scale of 0-6, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in body weight from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Relative Change From Baseline in Body Weight', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Relative change in body weight (measured as kg) from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Waist Circumference', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in waist circumference from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Body Mass Index (BMI)', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in BMI from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Weight Loss of >= 5% of Baseline Body Weight at Week 48', 'timeFrame': 'Week 48', 'description': 'Percentage of participants with weight loss of greater than or equal to (≥) 5% of baseline body weight at 48 weeks is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Percentage of Participants With Weight Loss of >= 10% of Baseline Body Weight at Week 48', 'timeFrame': 'Week 48', 'description': 'Percentage of participants with weight loss of ≥ 10% of baseline body weight at 48 weeks is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in HbA1c from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in FPG from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Fasting C-peptide-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in fasting C-peptide \\[measured as nanomoles per litre (nmol/L)\\] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Systolic And Diastolic Blood Pressure', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in systolic and diastolic blood pressure from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Total Cholesterol-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in total cholesterol (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in LDL cholesterol (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in HDL cholesterol (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in VLDL cholesterol (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Triglycerides-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in triglycerides (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Free Fatty Acids (FFA)-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in free fatty acids (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in High-Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in hsCRP (measured as milligrams per liter) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Alanine Aminotransferase (ALT)-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in ALT (measured as units per liter) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Aspartate Aminotransferase (AST)-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in AST (measured as units per liter) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Gamma-Glutamyl Transferase (GGT)-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in GGT (measured as units per liter) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Albumin-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in albumin \\[measured as grams per deciliter (g/dL)\\] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Changes From Baseline in Thrombocytes-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in thrombocytes \\[measured as 10\\^9 cells per liter\\] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in International Normalized Ratio (INR)-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in INR from baseline to week 48 is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Direct Bilirubin-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in direct bilirubin \\[measured as micromoles per liter (umol/L)\\] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Change From Baseline in Total Bilirubin-Ratio to Baseline', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in total bilirubin \\[measured as umol/L\\] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.'}, {'measure': 'Number of Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From baseline (week 0) to week 55', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. Outcome measure was evaluated based on data from on-treatment period which started on the date of first administration of trial product and ended on the date of whatever comes first of: a) last dose of trial product + 49 days (7 half-lives of semaglutide), b) follow-up visit (week 55), or c) end of the in-trial period.'}, {'measure': 'Number of Treatment-Emergent Hypoglycaemic Episodes', 'timeFrame': 'From baseline (week 0) to week 55', 'description': 'Hypoglycaemic episode (blood glucose less than or equal to (\\<=) 3.9 mmol/L \\[70 milligrams per decilitre (mg/dL)\\] Or greater than (\\>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. Outcome measure was evaluated based on data from on-treatment period which started on the date of first administration of trial product and ended on the date of whatever comes first of: a) last dose of trial product + 49 days (7 half-lives of semaglutide), b) follow-up visit (week 55), or c) end of the in-trial period.'}, {'measure': 'Change From Baseline in Pulse', 'timeFrame': 'Baseline (week 0), Week 48', 'description': 'Change in pulse from baseline to week 48 is presented. Outcome measure was evaluated based on data from on-treatment period which started on the date of first administration of trial product and ended on the date of whatever comes first of: a) last dose of trial product + 49 days (7 half-lives of semaglutide), b) follow-up visit (week 55), or c) end of the in-trial period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-alcoholic Steatohepatitis']}, 'referencesModule': {'references': [{'pmid': '36934740', 'type': 'BACKGROUND', 'citation': 'Loomba R, Abdelmalek MF, Armstrong MJ, Jara M, Kjaer MS, Krarup N, Lawitz E, Ratziu V, Sanyal AJ, Schattenberg JM, Newsome PN; NN9931-4492 investigators. Semaglutide 2.4 mg once weekly in patients with non-alcoholic steatohepatitis-related cirrhosis: a randomised, placebo-controlled phase 2 trial. Lancet Gastroenterol Hepatol. 2023 Jun;8(6):511-522. doi: 10.1016/S2468-1253(23)00068-7. Epub 2023 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'Semaglutide is a medicine studied in patients with non-alcoholic steatohepatitis (NASH), as it may improve liver damage. Participants will either get semaglutide or placebo (a dummy medicine) - which treatment participants get is decided by chance. The study will last for about 61 weeks in total. Participants will have 10 clinic visits and 3 phone calls with the study doctor or staff during the study. Some of the clinic visits may be spread over more days. Participants will need to inject themselves with medicine under the skin. Participants will have to do this once a week for 48 weeks. The study includes magnetic resonance imaging (MRI) scans of the liver, 1 or 2 liver tissue samples, ultrasound scans of the stomach and a possible examination of the food pipe. For some tests participants may need to remove some items of clothing. Participants will stop in the study if the doctor thinks that there are any risks for their health. The information collected from participants during the study may help them and other patients with NASH in the future. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.\n* Histologic evidence of NASH and fibrosis stage 4 according to the NASH CRN classification based on central pathologist evaluation of a liver biopsy obtained within 360 days prior to screening. In subjects who have never had a liver biopsy showing NASH and F4, liver stiffness above 14 kPa by FibroScan® at screening must be documented before subjects can have a trial-related liver biopsy\n* A histological NAFLD activity score (NAS) equal to or above 3 with a score of 1 or more in lobular inflammation and hepatocyte ballooning based on central pathologist evaluation\n* Body mass index equal to or above 27 kg/m\\^2\n\nExclusion Criteria:\n\n* Presence or history of hepatic decompensation (e.g. ascites, variceal bleeding, hepatic encephalopathy or spontaneous bacterial peritonitis) or liver transplantation\n* Presence or history of gastroesophageal varices within the past 360 days prior to screening. For subjects with no known history of gastroesophageal varices and with a Fibroscan® equal to or above 20 kPa and thrombocytes equal to or below 150,000, a esophagogastroduodenoscopy must be performed to evaluate presence of gastroesophageal varices\n* Presence or history of hepatocellular carcinoma\n* Treatment with vitamin E (at doses equal to or above 800 IU/day) or pioglitazone which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to screening\n* Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in the period from 90 days prior to screening\n* Treatment with other glucose lowering agent(s) (apart from what is listed in the exclusion criterion above) or weight loss medication not stable in the opinion of the investigator in the period from 28 days prior to screening'}, 'identificationModule': {'nctId': 'NCT03987451', 'briefTitle': 'A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Investigation of Efficacy and Safety of Semaglutide s.c. Once-weekly Versus Placebo in Subjects With Non-alcoholic Steatohepatitis and Compensated Liver Cirrhosis', 'orgStudyIdInfo': {'id': 'NN9931-4492'}, 'secondaryIdInfos': [{'id': 'U1111-1224-4062', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2018-004484-31', 'type': 'REGISTRY', 'domain': 'European Medicines Agency (EudraCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semaglutide', 'description': 'Dose escalation to 2.4 mg of semaglutide once-weekly', 'interventionNames': ['Drug: Semaglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Semaglutide placebo once-weekly', 'interventionNames': ['Drug: Placebo (semaglutide)']}], 'interventions': [{'name': 'Semaglutide', 'type': 'DRUG', 'description': 'Semaglutide given subcutaneously (s.c., under the skin) once-weekly for 48 weeks', 'armGroupLabels': ['Semaglutide']}, {'name': 'Placebo (semaglutide)', 'type': 'DRUG', 'description': 'Semaglutide placebo s.c. given once-weekly for 48 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Liver Health', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'The Institute for Liver Health dba Arizona Liver Health', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '92118', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Research Center', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Altman Clinical Translational Research Institute', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92377', 'city': 'Rialto', 'state': 'California', 'country': 'United States', 'facility': 'Inland Empire Clinical Trials LLC', 'geoPoint': {'lat': 34.1064, 'lon': -117.37032}}, {'zip': '33434', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Excel Medical Center Clinical Trials, LLC', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida-CTRB', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami/Schiff Center for Liver Diseases', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Research Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gastrointestinal Specialists of Georgia', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46635', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Digestive Research Alliance of Michiana', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '40508', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Hospital', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mercy Medical Center, GI Research', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Gastroenterology Center For The Mid-South', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '37076', 'city': 'Hermitage', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Digestive Health Research - 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