Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT04844918
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2021-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'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': 'D000098860', 'term': 'Tirzepatide'}], 'ancestors': [{'id': 'D000067757', 'term': 'Glucagon-Like Peptide-1 Receptor'}, {'id': 'D000067756', 'term': 'Glucagon-Like Peptide Receptors'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011964', 'term': 'Receptors, Gastrointestinal Hormone'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline Through Safety Follow-Up (Up To 76 Weeks)', 'description': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.', 'eventGroups': [{'id': 'EG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide SC QW\n\n.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 59, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 65, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 51, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Paroxysmal arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': "Gilbert's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Conductive deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 16, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 40, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pancreatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 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infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Otitis media chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percent Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.8', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-22.7', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '0.90', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.1', 'ciLowerLimit': '-18.7', 'ciUpperLimit': '-13.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.1', 'ciLowerLimit': '-23.6', 'ciUpperLimit': '-18.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 72 Weeks', 'description': 'Mean percent change in body weight was measured. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + impaired glucose tolerance (IGT) at Screening + Hyperlipidemia at Screening + non-alcoholic fatty liver disease (NAFLD) at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieve ≥5% Body Weight Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.37', 'groupId': 'OG000'}, {'value': '96.05', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '119.65', 'ciLowerLimit': '29.06', 'ciUpperLimit': '492.67', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '153.57', 'ciLowerLimit': '36.03', 'ciUpperLimit': '654.53', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieve ≥5% Body Weight Reduction', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug, had a baseline and at least one post-baseline value for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had Improvement in Obesity-related Health Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}, {'value': '79.69', 'groupId': 'OG001'}, {'value': '11.11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.26', 'ciLowerLimit': '8.62', 'ciUpperLimit': '68.28', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.27', 'ciLowerLimit': '13.21', 'ciUpperLimit': '110.89', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'Percentage of participants who had improvement in obesity-related health problems', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Glucose for Participants With IGT at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.81', 'spread': '1.490', 'groupId': 'OG000'}, {'value': '-10.61', 'spread': '1.391', 'groupId': 'OG001'}, {'value': '2.19', 'spread': '1.291', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.00', 'ciLowerLimit': '-18.91', 'ciUpperLimit': '-11.09', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.80', 'ciLowerLimit': '-16.56', 'ciUpperLimit': '-9.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in Fasting Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-61.50', 'spread': '5.330', 'groupId': 'OG000'}, {'value': '-70.56', 'spread': '4.951', 'groupId': 'OG001'}, {'value': '-5.74', 'spread': '4.612', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-55.76', 'ciLowerLimit': '-69.74', 'ciUpperLimit': '-41.77', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-64.82', 'ciLowerLimit': '-78.20', 'ciUpperLimit': '-51.43', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in OGTT 2-hr Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-47.3', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '-50.6', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '-11.0', 'spread': '5.14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.7', 'ciLowerLimit': '-50.0', 'ciUpperLimit': '-29.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-44.5', 'ciLowerLimit': '-52.7', 'ciUpperLimit': '-34.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Percent Change from Baseline in Fasting Lipids TG for Participants with Hyperlipidemia at Baseline. LS mean was determined by MMRM model with log (Baseline) + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who had hyperlipidemia at baseline, received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-63.9', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '-69.9', 'spread': '2.99', 'groupId': 'OG001'}, {'value': '-19.6', 'spread': '3.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-44.4', 'ciLowerLimit': '-53.0', 'ciUpperLimit': '-35.7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.4', 'ciLowerLimit': '-58.8', 'ciUpperLimit': '-41.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Percent Change from Baseline in HFF for participants diagnosed as NAFLD by MRI at Baseline. LS mean was determined by ANCOVA model with Baseline + Hyperlipidemia at Screening + IGT at Screening + Sex + Treatment (Type III sum of squares) as variables. Percent Change from Baseline in HFF for participants with NAFLD is reported. NAFLD was diagnosed by Magnetic Resonance Imaging (MRI) at Baseline. This was evaluated only for participants who were diagnosed with NAFLD at baseline by MRI.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who were diagnosed as NAFLD by MRI at baseline and received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Improvements of IGT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.50', 'groupId': 'OG000'}, {'value': '97.83', 'groupId': 'OG001'}, {'value': '28.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.42', 'ciLowerLimit': '7.25', 'ciUpperLimit': '89.14', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '70.66', 'ciLowerLimit': '12.73', 'ciUpperLimit': '392.24', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieved Improvements of IGT. This was evaluated only for participants with IGT at baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Improvements of Hyperlipidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.41', 'groupId': 'OG000'}, {'value': '81.08', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.29', 'ciLowerLimit': '2.86', 'ciUpperLimit': '30.20', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.67', 'ciLowerLimit': '4.78', 'ciUpperLimit': '51.37', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieved Improvements of Hyperlipidemia. This was evaluated only for participants with hyperlipidemia at baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, with hyperlipidemia at baseline, received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Improvements of NAFLD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.49', 'groupId': 'OG000'}, {'value': '77.42', 'groupId': 'OG001'}, {'value': '9.84', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.50', 'ciLowerLimit': '9.35', 'ciUpperLimit': '80.88', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.01', 'ciLowerLimit': '13.27', 'ciUpperLimit': '120.57', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieved Improvements of NAFLD. This was evaluated only for participants who were diagnosed as NAFLD by MRI at Baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, diagnosed as NAFLD by MRI at baseline, received at least one dose of study drug, and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve ≥10% Body Weight Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.92', 'groupId': 'OG000'}, {'value': '92.11', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '185.92', 'ciLowerLimit': '46.39', 'ciUpperLimit': '745.16', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '318.02', 'ciLowerLimit': '74.49', 'ciUpperLimit': '1357.79', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieve ≥10% body weight reduction.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve ≥15% Body Weight Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.38', 'groupId': 'OG000'}, {'value': '82.89', 'groupId': 'OG001'}, {'value': '1.33', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.21', 'ciLowerLimit': '18.64', 'ciUpperLimit': '538.74', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '286.73', 'ciLowerLimit': '50.68', 'ciUpperLimit': '1622.06', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieve ≥15% body weight reduction.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Absolute Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.0', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-20.8', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.82', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.5', 'ciLowerLimit': '-16.8', 'ciUpperLimit': '-12.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.3', 'ciLowerLimit': '-21.6', 'ciUpperLimit': '-17.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in Absolute Body Weight. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.8', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.30', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.2', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '-4.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.1', 'ciLowerLimit': '-8.0', 'ciUpperLimit': '-6.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'kilograms per metres squared (kg/m^2)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Visceral Adipose Tissue (VAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-39.4', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '-44.5', 'spread': '2.37', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '2.42', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.1', 'ciLowerLimit': '-42.9', 'ciUpperLimit': '-29.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.1', 'ciLowerLimit': '-47.8', 'ciUpperLimit': '-34.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Percent Change from Baseline in VAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.2', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '-36.5', 'spread': '1.85', 'groupId': 'OG001'}, {'value': '-5.0', 'spread': '1.90', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.2', 'ciLowerLimit': '-32.6', 'ciUpperLimit': '-21.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.5', 'ciLowerLimit': '-36.7', 'ciUpperLimit': '-26.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Percent Change from Baseline in SAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in VAT/SAT Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.023', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.023', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.023', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '-0.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.006', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '-0.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in VAT/SAT Ratio. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.32', 'groupId': 'OG000'}, {'value': '37.10', 'groupId': 'OG001'}, {'value': '1.64', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.52', 'ciLowerLimit': '4.31', 'ciUpperLimit': '188.55', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '57.73', 'ciLowerLimit': '8.68', 'ciUpperLimit': '383.88', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieve VAT \\<100 cm² from Baseline for participants with VAT≥100 cm² at Baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.7', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-16.6', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '0.84', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.4', 'ciLowerLimit': '-13.8', 'ciUpperLimit': '-9.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-17.7', 'ciUpperLimit': '-13.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with = Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.045', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.042', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.039', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '-0.53', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '-0.55', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in HbA1c was assessed only for Participants with IGT at Baseline. LS mean was determined using MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Insulin for Participants With IGT at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.04', 'spread': '0.517', 'groupId': 'OG000'}, {'value': '-6.69', 'spread': '0.433', 'groupId': 'OG001'}, {'value': '-2.13', 'spread': '0.776', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.91', 'ciLowerLimit': '-5.74', 'ciUpperLimit': '-2.08', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.55', 'ciLowerLimit': '-6.29', 'ciUpperLimit': '-2.81', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in Fasting Insulin for Participants with IGT at Baseline. LS mean was determined using MMRM model log(Baseline) + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'milli-international units/liter (mIU/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug, and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.2', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '-12.0', 'spread': '1.35', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.2', 'ciLowerLimit': '-17.0', 'ciUpperLimit': '-9.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.9', 'ciLowerLimit': '-17.7', 'ciUpperLimit': '-10.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in Systolic Blood Pressure. LS mean was determined using MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'millimeters of Mercury (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.9', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '1.04', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.3', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '-3.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.8', 'ciLowerLimit': '-9.7', 'ciUpperLimit': '-3.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in Diastolic Blood Pressure. LS mean was determined using MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'millimeters of Mercury (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.37', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.2', 'ciUpperLimit': '2.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '1.1', 'ciUpperLimit': '3.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': "The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary.\n\nItems are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '1.95', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.96', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.0', 'ciLowerLimit': '7.4', 'ciUpperLimit': '18.7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.8', 'ciLowerLimit': '5.4', 'ciUpperLimit': '16.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.011', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.011', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.011', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.099', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.06', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.236', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, unable to perform/extreme problems). In addition to the health profile, a single health state index value can be derived based on a formula that attaches weights to each of the levels in each dimension. This index value ranges between\n\n˂0 (where 0 is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '10 Milligrams (mg) Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW).'}, {'id': 'FG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '89'}]}, {'type': 'Received At Least 1 Dose of Study Drug (Excluding the GCP Compliance Investigative Site)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Participants Excluded Due to GCP Compliance Issue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '14'}]}]}], 'recruitmentDetails': '267 participants were randomized in the study. However, due to good clinical practice (GCP) compliance issues identified at one of the investigative sites, all 42 participants from that site were excluded from the study analyses'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.'}, {'id': 'BG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.00', 'spread': '10.87', 'groupId': 'BG000'}, {'value': '51.10', 'spread': '10.30', 'groupId': 'BG001'}, {'value': '52.30', 'spread': '10.93', 'groupId': 'BG002'}, {'value': '50.80', 'spread': '10.74', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-11', 'size': 3692047, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-16T23:43', 'hasProtocol': True}, {'date': '2023-07-11', 'size': 952808, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-16T23:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 267}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-20', 'studyFirstSubmitDate': '2021-04-01', 'resultsFirstSubmitDate': '2024-06-20', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-20', 'studyFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent Change in Body Weight', 'timeFrame': 'Baseline, 72 Weeks', 'description': 'Mean percent change in body weight was measured. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + impaired glucose tolerance (IGT) at Screening + Hyperlipidemia at Screening + non-alcoholic fatty liver disease (NAFLD) at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Percentage of Participants Who Achieve ≥5% Body Weight Reduction', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieve ≥5% Body Weight Reduction'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Had Improvement in Obesity-related Health Problems', 'timeFrame': 'Week 72', 'description': 'Percentage of participants who had improvement in obesity-related health problems'}, {'measure': 'Change From Baseline in Fasting Glucose for Participants With IGT at Baseline', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in Fasting Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in OGTT 2-hr Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline', 'timeFrame': 'Baseline, Week 72', 'description': 'Percent Change from Baseline in Fasting Lipids TG for Participants with Hyperlipidemia at Baseline. LS mean was determined by MMRM model with log (Baseline) + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD]', 'timeFrame': 'Baseline, Week 72', 'description': 'Percent Change from Baseline in HFF for participants diagnosed as NAFLD by MRI at Baseline. LS mean was determined by ANCOVA model with Baseline + Hyperlipidemia at Screening + IGT at Screening + Sex + Treatment (Type III sum of squares) as variables. Percent Change from Baseline in HFF for participants with NAFLD is reported. NAFLD was diagnosed by Magnetic Resonance Imaging (MRI) at Baseline. This was evaluated only for participants who were diagnosed with NAFLD at baseline by MRI.'}, {'measure': 'Percentage of Participants Who Achieved Improvements of IGT', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieved Improvements of IGT. This was evaluated only for participants with IGT at baseline.'}, {'measure': 'Percentage of Participants Who Achieved Improvements of Hyperlipidemia', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieved Improvements of Hyperlipidemia. This was evaluated only for participants with hyperlipidemia at baseline.'}, {'measure': 'Percentage of Participants Who Achieved Improvements of NAFLD', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieved Improvements of NAFLD. This was evaluated only for participants who were diagnosed as NAFLD by MRI at Baseline.'}, {'measure': 'Percentage of Participants Who Achieve ≥10% Body Weight Reduction', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieve ≥10% body weight reduction.'}, {'measure': 'Percentage of Participants Who Achieve ≥15% Body Weight Reduction', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieve ≥15% body weight reduction.'}, {'measure': 'Change From Baseline in Absolute Body Weight', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in Absolute Body Weight. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Change From Baseline in Body Mass Index (BMI)', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Percent Change From Baseline in Visceral Adipose Tissue (VAT)', 'timeFrame': 'Baseline, Week 72', 'description': 'Percent Change from Baseline in VAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT)', 'timeFrame': 'Baseline, Week 72', 'description': 'Percent Change from Baseline in SAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Change From Baseline in VAT/SAT Ratio', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in VAT/SAT Ratio. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline', 'timeFrame': 'Week 72', 'description': 'Percentage of Participants Who Achieve VAT \\<100 cm² from Baseline for participants with VAT≥100 cm² at Baseline.'}, {'measure': 'Change From Baseline in Waist Circumference', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with = Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in HbA1c was assessed only for Participants with IGT at Baseline. LS mean was determined using MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Change From Baseline in Fasting Insulin for Participants With IGT at Baseline', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in Fasting Insulin for Participants with IGT at Baseline. LS mean was determined using MMRM model log(Baseline) + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in Systolic Blood Pressure. LS mean was determined using MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Change From Baseline in Diastolic Blood Pressure', 'timeFrame': 'Baseline, Week 72', 'description': 'Change from Baseline in Diastolic Blood Pressure. LS mean was determined using MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Change From Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score', 'timeFrame': 'Baseline, Week 72', 'description': "The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary.\n\nItems are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables."}, {'measure': 'Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score', 'timeFrame': 'Baseline, Week 72', 'description': 'The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.'}, {'measure': 'Change From Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)', 'timeFrame': 'Baseline, Week 72', 'description': 'The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, unable to perform/extreme problems). In addition to the health profile, a single health state index value can be derived based on a formula that attaches weights to each of the levels in each dimension. This index value ranges between\n\n˂0 (where 0 is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolism and Nutrition Disorder', 'Obesity Related Health Problems', 'Obesity Disease'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '41290555', 'type': 'DERIVED', 'citation': 'Yokote K, Fukushima Y, Shingaki T, Oura T, Ogawa W. Association of baseline characteristics with clinical outcomes of tirzepatide treatment in Japanese patients with obesity disease: A subgroup analysis of the SURMOUNT-J trial. Diabetes Obes Metab. 2025 Nov 25. doi: 10.1111/dom.70315. Online ahead of print.'}, {'pmid': '40031941', 'type': 'DERIVED', 'citation': 'Kadowaki T, Kiyosue A, Shingaki T, Oura T, Yokote K. Efficacy and safety of once-weekly tirzepatide in Japanese patients with obesity disease (SURMOUNT-J): a multicentre, randomised, double-blind, placebo-controlled phase 3 trial. Lancet Diabetes Endocrinol. 2025 May;13(5):384-396. doi: 10.1016/S2213-8587(24)00377-2. Epub 2025 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to learn more about tirzepatide in participants with obesity disease. The study will also measure how Tirzepatide affects body weight with a low-calorie diet and increased physical activity. The study will last around 72 Weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a BMI of greater than or equal to ≥27 kg/m² and \\<less than 35 kg/m² with at least 2 obesity-related health problems or ≥35 kg/m² with at least 1 obesity-related health problems. Health problems are IGT, hyperlipidemia, or NAFLD.\n* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.\n\nExclusion Criteria:\n\n* Have diabetes.\n* Acute or chronic liver disease other than NAFLD.\n* Have a self-reported change in body weight \\>5 kg within 3 months prior to screening.\n* Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months.\n* Have renal impairment measured as estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73 m2, calculated by Japanese Society of Nephrology coefficient-modified Chronic Kidney Disease-Epidemiology equation during screening.\n* Have a known clinically significant gastric emptying abnormality.\n* Have had a history of chronic or acute pancreatitis.\n* Have thyroid-stimulating hormone outside of the range of 0.4 to 6.0 micro units per milliliter (μIU/mL) at screening.\n* Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.\n* Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years.\n* Have a cardiovascular condition within 3 months prior to randomization\n* Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome type 2.'}, 'identificationModule': {'nctId': 'NCT04844918', 'acronym': 'SURMOUNT-J', 'briefTitle': 'A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Efficacy and Safety of Once-Weekly Tirzepatide in Participants With Obesity Disease: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-J)', 'orgStudyIdInfo': {'id': '17506'}, 'secondaryIdInfos': [{'id': 'I8F-JE-GPHZ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 Milligrams (mg) Tirzepatide', 'description': 'Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW).', 'interventionNames': ['Drug: Tirzepatide']}, {'type': 'EXPERIMENTAL', 'label': '15 mg Tirzepatide', 'description': 'Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.', 'interventionNames': ['Drug: Tirzepatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received matching placebo administered SC QW.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tirzepatide', 'type': 'DRUG', 'otherNames': ['LY3298176'], 'description': 'Administered SC', 'armGroupLabels': ['10 Milligrams (mg) Tirzepatide', '15 mg Tirzepatide']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '272-8516', 'city': 'Ichikawa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Kohnodai Hospital, National Center for Global Health and Medicine', 'geoPoint': {'lat': 35.73413, 'lon': 139.9065}}, {'zip': '791-8026', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Saiseikai Matsuyama Hospital', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '247-0056', 'city': 'Kamakura-shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Takai Internal Medicine Clinic'}, {'zip': '2308765', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Saiseikai Yokohamashi Tobu Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '231-0023', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Motomachi Takatsuka Naika Clinic', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '564-0013', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Saiseikai Suita hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '565-0853', 'city': 'Suita-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Medical Corporation Heishinkai OCROM Clinic'}, {'zip': '569-1045', 'city': 'Takatsuki', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Takatsuki Red Cross Hospital', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'zip': '103-0002', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'The Institute for Adult Disease, Asahi Life Foundation'}, {'zip': '103-0027', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo-Eki Center-building Clinic'}, {'zip': '103-0028', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Medical Corporation Chiseikai Tokyo Center Clinic'}, {'zip': '104-0031', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Fukuwa Clinic'}, {'zip': '108-0073', 'city': 'Minato-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Saiseikai Central Hospital'}, {'zip': '155-0031', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Shimokitazawa Tomo Clinic'}, {'zip': '141 0032', 'city': 'Shinagawa-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Miho Clinic'}, {'zip': '160 0008', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Medical Corporation Heishinkai ToCROM Clinic'}, {'zip': '990-0834', 'city': 'Yamagata', 'state': 'Yamagata', 'country': 'Japan', 'facility': 'Yamagata Tokushukai Hospital', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}, {'zip': '530-0001', 'city': 'Osaka', 'country': 'Japan', 'facility': 'AMC Nishiumeda Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Call 1-877-CTLilly (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT -5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}