Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT04074161
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2019-08-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}, {'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, '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 75', 'description': 'All presented AEs are treatment-emergent (i.e., TEAEs). TEAEs defined as AEs, with the onset of the event occurred in the on-treatment period. Results are based on the SAS which included all randomized participants exposed to at least one dose of randomized treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 115, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 115, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 68, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 80, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 52, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 51, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 37, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 46, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 130, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 102, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 24, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 23, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 50, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 34, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}], 'seriousEvents': [{'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Cardiac ablation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Invasive lobular breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Lactose intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Post procedural drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Uterine enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}, {'term': 'Viral sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.4', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '7.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.38', 'ciLowerLimit': '-11.97', 'ciUpperLimit': '-6.80', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Responses were analysed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Percentage of body weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The full analysis set (FAS) included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. It was planned to report data only for arms 'semaglutide 2.4 mg and liraglutide 3.0 mg' for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline (week 0) to week 68', 'description': "Number of participants who achieved \\>= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>= 10% weight reduction, whereas 'No' infers the number of participants who did not achieve \\>= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline (week 0) to week 68', 'description': "Number of participants who achieved \\>= 15% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>= 15% weight reduction, whereas 'No' infers the number of participants who did not achieve \\>= 15% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline (week 0) to week 68', 'description': "Number of participants who achieved \\>= 20% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>= 20% weight reduction, whereas 'No' infers the number of participants who did not achieve \\>= 20% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.6', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '7.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in waist circumference is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.8', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '9.5', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '9.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in body weight is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Pooled Placebo and Liraglutide 3.0 mg Versus Pooled Placebo)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.4', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '8.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Percentage of body weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7', 'spread': '14', 'groupId': 'OG000'}, {'value': '-4', 'spread': '15', 'groupId': 'OG001'}, {'value': '5', 'spread': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in systolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5', 'spread': '9', 'groupId': 'OG000'}, {'value': '-1', 'spread': '11', 'groupId': 'OG001'}, {'value': '1', 'spread': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in diastolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '15.0', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '17.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in total cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of total cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '15.0', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '17.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of total cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '15.4', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of HDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '15.4', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of HDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '23.4', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '26.3', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of LDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '23.4', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '26.3', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of LDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.79', 'spread': '33.1', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '36.9', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '34.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of VLDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.79', 'spread': '33.1', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '36.9', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '34.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of VLDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'spread': '81.5', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '77.7', 'groupId': 'OG001'}, {'value': '1.10', 'spread': '77.2', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in FFA (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of FFA', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'spread': '81.5', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '77.7', 'groupId': 'OG001'}, {'value': '1.10', 'spread': '77.2', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in FFA (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of FFA', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.80', 'spread': '33.0', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '36.7', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '35.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in triglycerides (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of triglycerides', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.80', 'spread': '33.0', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '36.7', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '35.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in triglycerides (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of triglycerides', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'spread': '154.1', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '93.0', 'groupId': 'OG001'}, {'value': '0.78', 'spread': '71.5', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in hs-CRP (measured in mg/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of hs-CRP', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in HbA1c (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Percenatge of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.8', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in HbA1c is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.0', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '10.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in fasting plasma glucose is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in fasting plasma glucose is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'spread': '57.3', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '47.5', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '56.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in fasting serum insulin (measured in mIU/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of fasting serum insulin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'spread': '57.3', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '47.5', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '56.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in fasting serum insulin (measured in pmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.", 'unitOfMeasure': 'Ratio of fasting serum insulin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'title': 'Baseline (week 0): normo-glycaemia', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (week 0): pre-diabetes', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (week 0): type 2 diabetes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 68: normo-glycaemia', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Week 68: pre-diabetes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'Week 68: type 2 diabetes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Number of participants in glycaemic categories, "normo-glycaemia, pre-diabetes and type 2 diabetes" at baseline (week 0) and 68 are presented. These categories were set as per the following criteria: 1) Normo-glycaemia: fasting plasma glucose (FPG) less than (\\<) 5.6 mmol/L (\\<100 mg/dL) and/or glycated haemoglobin (HbA1c) \\<5.7%; 2) Pre-diabetes: FPG 5.6 - 6.9 mmol/L (both inclusive), FPG 100 - 125 mg/dL (both inclusive) or HbA1c 5.7 - 6.4% (both inclusive); 3) Type 2 diabetes: FPG greater than or equal to (\\>=) 7.0 mmol/L (\\>=126 mg/dL) and/or HbA1c \\>=6.5%. Data is reported for \'in-trial\' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline (week 0) to week 68', 'description': 'Number of participants who from baseline (week 0) to week 68 permanently discontinued randomized trial product are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '904', 'groupId': 'OG000'}, {'value': '823', 'groupId': 'OG001'}, {'value': '522', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to week 75', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All AEs mentioned here are TEAEs defined as AEs, with the onset of the event occurred in the on-treatment period. A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set (SAS) included all randomized participants exposed to at least one dose of randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'OG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) to week 75', 'description': 'An AE was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as an AE that results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. SAEs occurred based on the on-treatment period is presented. A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all randomized participants exposed to at least one dose of randomized treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'FG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'FG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '85'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '85'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The trial was conducted at 19 sites in the United States (US).', 'preAssignmentDetails': 'Total 338 adults with obesity (BMI greater than or equal to (\\>=30.0) kilograms per square meter (kg/m\\^2)) or overweight (BMI \\>= 27.0 kg/m\\^2) and at least one weight-related comorbidity were randomized in a 3:1:3:1 manner to receive treatment with either semaglutide subcutaneously (s.c.) 2.4 milligram (mg) once weekly or semaglutide placebo once weekly or liraglutide s.c. 3.0 mg once daily or liraglutide placebo once daily as an adjunct to a reduced-calorie diet and increased physical activity.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '338', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Semaglutide 2.4 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'BG001', 'title': 'Liraglutide 3.0 mg', 'description': 'The trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'BG002', 'title': 'Pooled Placebo', 'description': 'Participants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '14', 'groupId': 'BG000'}, {'value': '49', 'spread': '13', 'groupId': 'BG001'}, {'value': '51', 'spread': '12', 'groupId': 'BG002'}, {'value': '49', 'spread': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '265', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set (FAS) included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-25', 'size': 1324209, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-21T03:31', 'hasProtocol': True}, {'date': '2021-07-08', 'size': 552012, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-21T03:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Semaglutide once weekly vs liraglutide once daily treatment will be open label, but each of the two active treatment arms will be double blinded against placebo administered at the same dosing frequency.\n\nSponsor staff involved in the clinical trial is masked according to company standard procedures.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 338}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-18', 'studyFirstSubmitDate': '2019-08-28', 'resultsFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2019-08-28', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-26', 'studyFirstPostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)', 'timeFrame': 'From baseline (week 0) to week 68', 'description': "Number of participants who achieved \\>= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>= 10% weight reduction, whereas 'No' infers the number of participants who did not achieve \\>= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)', 'timeFrame': 'From baseline (week 0) to week 68', 'description': "Number of participants who achieved \\>= 15% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>= 15% weight reduction, whereas 'No' infers the number of participants who did not achieve \\>= 15% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)', 'timeFrame': 'From baseline (week 0) to week 68', 'description': "Number of participants who achieved \\>= 20% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved \\>= 20% weight reduction, whereas 'No' infers the number of participants who did not achieve \\>= 20% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Waist Circumference', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in waist circumference is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in body weight is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Pooled Placebo and Liraglutide 3.0 mg Versus Pooled Placebo)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in systolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in diastolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in total cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in FFA (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in FFA (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in triglycerides (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in triglycerides (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in hs-CRP (measured in mg/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in HbA1c (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol))', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in HbA1c is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in fasting plasma glucose is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L)', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in fasting plasma glucose is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in fasting serum insulin (measured in mIU/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline', 'timeFrame': 'Baseline (week 0), week 68', 'description': "Change from baseline (week 0) to week 68 in fasting serum insulin (measured in pmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site."}, {'measure': 'Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D))', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Number of participants in glycaemic categories, "normo-glycaemia, pre-diabetes and type 2 diabetes" at baseline (week 0) and 68 are presented. These categories were set as per the following criteria: 1) Normo-glycaemia: fasting plasma glucose (FPG) less than (\\<) 5.6 mmol/L (\\<100 mg/dL) and/or glycated haemoglobin (HbA1c) \\<5.7%; 2) Pre-diabetes: FPG 5.6 - 6.9 mmol/L (both inclusive), FPG 100 - 125 mg/dL (both inclusive) or HbA1c 5.7 - 6.4% (both inclusive); 3) Type 2 diabetes: FPG greater than or equal to (\\>=) 7.0 mmol/L (\\>=126 mg/dL) and/or HbA1c \\>=6.5%. Data is reported for \'in-trial\' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.'}, {'measure': 'Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product', 'timeFrame': 'From baseline (week 0) to week 68', 'description': 'Number of participants who from baseline (week 0) to week 68 permanently discontinued randomized trial product are presented.'}, {'measure': 'Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75', 'timeFrame': 'From baseline (week 0) to week 75', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All AEs mentioned here are TEAEs defined as AEs, with the onset of the event occurred in the on-treatment period. A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days.'}, {'measure': 'Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75', 'timeFrame': 'From baseline (week 0) to week 75', 'description': 'An AE was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was defined as an AE that results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. SAEs occurred based on the on-treatment period is presented. A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '34775881', 'type': 'RESULT', 'citation': 'Wharton S, Davies M, Dicker D, Lingvay I, Mosenzon O, Rubino DM, Pedersen SD. Managing the gastrointestinal side effects of GLP-1 receptor agonists in obesity: recommendations for clinical practice. Postgrad Med. 2022 Jan;134(1):14-19. doi: 10.1080/00325481.2021.2002616. Epub 2021 Nov 29.'}, {'pmid': '35015037', 'type': 'RESULT', 'citation': "Rubino DM, Greenway FL, Khalid U, O'Neil PM, Rosenstock J, Sorrig R, Wadden TA, Wizert A, Garvey WT; STEP 8 Investigators. Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial. JAMA. 2022 Jan 11;327(2):138-150. doi: 10.1001/jama.2021.23619."}, {'pmid': '35791625', 'type': 'DERIVED', 'citation': 'Snitker S, Egebjerg C, Frederiksen M, Sparre T. Ease-of-use and acceptability of the novel semaglutide 2.4 mg single-dose pen-injector in people with overweight or obesity in the STEP 8 phase III trial. Diabetes Obes Metab. 2022 Nov;24(11):2273-2276. doi: 10.1111/dom.14809. Epub 2022 Aug 7. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study will look at participants\' body weight from the start to the end of the study. The study will last for about 1½ years. This is to compare the effect on body weight in people taking semaglutide once a week or people taking liraglutide once every day. Participants will either get semaglutide, liraglutide or "dummy" medicine. Which treatment is decided by chance. Participants who receive semaglutide or semaglutide "dummy" medicine will need to take 1 injection once a week. Participants who receive liraglutide or liraglutide "dummy" medicine will need to take 1 injection once daily. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study participants will have talks with study staff about eating healthy food and how to be more physically active. Participants will have 16 clinic visits and 7 phone calls with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age 18 years or older at the time of signing informed consent\n* Body mass index (BMI) equal to or above 30.0 kg/m\\^2 or equal to or above 27.0 kg/m\\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease\n* History of at least one self-reported unsuccessful dietary effort to lose body weight\n\nExclusion Criteria:\n\n* HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening\n* History of type 1 or type 2 diabetes mellitus\n* A self-reported change in body weight of more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records'}, 'identificationModule': {'nctId': 'NCT04074161', 'acronym': 'STEP 8', 'briefTitle': 'Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Effect and Safety of Subcutaneous Semaglutide 2.4 mg Once Weekly Compared to Liraglutide 3.0 mg Once Daily on Weight Management in Subjects With Overweight or Obesity', 'orgStudyIdInfo': {'id': 'NN9536-4576'}, 'secondaryIdInfos': [{'id': 'U1111-1233-0977', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semaglutide', 'description': 'Semaglutide administered s.c. (subcutaneously, under the skin) adjunct to a reduced-calorie diet and increased physical activity', 'interventionNames': ['Drug: Semaglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (semaglutide)', 'description': 'Placebo (semaglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity', 'interventionNames': ['Drug: Placebo (semaglutide)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liraglutide', 'description': 'Liraglutide administered s.c. adjunct to a reduced-calorie diet and increased physical activity', 'interventionNames': ['Drug: Liraglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (liraglutide)', 'description': 'Placebo (liraglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity', 'interventionNames': ['Drug: Placebo (liraglutide)']}], 'interventions': [{'name': 'Semaglutide', 'type': 'DRUG', 'description': 'Dose gradually increased to 2.4 mg administered once weekly for 68 weeks', 'armGroupLabels': ['Semaglutide']}, {'name': 'Placebo (semaglutide)', 'type': 'DRUG', 'description': 'Administered once weekly for 68 weeks', 'armGroupLabels': ['Placebo (semaglutide)']}, {'name': 'Liraglutide', 'type': 'DRUG', 'description': 'Dose gradually increased to 3.0 mg administered once daily for 68 weeks', 'armGroupLabels': ['Liraglutide']}, {'name': 'Placebo (liraglutide)', 'type': 'DRUG', 'description': 'Administered once daily for 68 weeks', 'armGroupLabels': ['Placebo (liraglutide)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '32205', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60201-2477', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '12203', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '19104-3317', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75226', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75032', 'city': 'Rockwall', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.93123, 'lon': -96.45971}}, {'zip': '22206', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}, {'zip': '22601-3834', 'city': 'Winchester', 'state': 'Virginia', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.18566, 'lon': -78.16333}}, {'zip': '98502', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}], 'overallOfficials': [{'name': 'Clinical Reporting Anchor and Disclosure (1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}