Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-25 @ 4:55 PM
Study NCT ID:
NCT04657003
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2020-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'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 Week 76', 'description': 'All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.', 'otherNumAtRisk': 315, 'deathsNumAtRisk': 315, 'otherNumAffected': 158, 'seriousNumAtRisk': 315, 'deathsNumAffected': 0, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.', 'otherNumAtRisk': 312, 'deathsNumAtRisk': 312, 'otherNumAffected': 169, 'seriousNumAtRisk': 312, 'deathsNumAffected': 2, 'seriousNumAffected': 18}, {'id': 'EG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.', 'otherNumAtRisk': 311, 'deathsNumAtRisk': 311, 'otherNumAffected': 159, 'seriousNumAtRisk': 311, 'deathsNumAffected': 0, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 17, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 31, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 31, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 40, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 40, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 127, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 180, 'numAffected': 66}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 50, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 31, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 23, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 250, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 157, 'numAffected': 68}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 56, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 60, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 55, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 55, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 40, 'numAffected': 31}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 46, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 27, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hernial eventration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Inguinal hernia strangulated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Limb traumatic amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Absolute Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-13.5', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '-15.6', 'spread': '0.51', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.3', 'ciLowerLimit': '-11.7', 'ciUpperLimit': '-8.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.4', 'ciLowerLimit': '-13.8', 'ciUpperLimit': '-11.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares).', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '0.19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.7', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '-3.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.5', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '-4.0', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares).', 'unitOfMeasure': 'kilograms per meter squared (kg/m^2)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}, {'value': '300', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '-2.14', 'spread': '0.060', 'groupId': 'OG001'}, {'value': '-2.22', 'spread': '0.060', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.97', 'ciLowerLimit': '-2.15', 'ciUpperLimit': '-1.80', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.06', 'ciLowerLimit': '-2.24', 'ciUpperLimit': '-1.88', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares).', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve HbA1c <7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}, {'value': '300', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.31', 'groupId': 'OG000'}, {'value': '90.03', 'groupId': 'OG001'}, {'value': '90.67', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.01', 'ciLowerLimit': '17.21', 'ciUpperLimit': '45.59', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.19', 'ciLowerLimit': '20.27', 'ciUpperLimit': '57.67', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'Percentage of participants who achieve HbA1c \\<7%', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve HbA1c ≤6.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}, {'value': '300', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.52', 'groupId': 'OG000'}, {'value': '84.05', 'groupId': 'OG001'}, {'value': '86.67', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.11', 'ciLowerLimit': '25.61', 'ciUpperLimit': '69.26', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '58.67', 'ciLowerLimit': '34.29', 'ciUpperLimit': '100.37', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'Percentage of participants who achieve HbA1c ≤6.5%', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve HbA1c <5.7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}, {'value': '300', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.76', 'groupId': 'OG000'}, {'value': '50.17', 'groupId': 'OG001'}, {'value': '55.33', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.55', 'ciLowerLimit': '20.46', 'ciUpperLimit': '88.50', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '54.30', 'ciLowerLimit': '26.00', 'ciUpperLimit': '113.38', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'Percentage of participants who achieve HbA1c \\<5.7%', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '300', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.42', 'spread': '2.281', 'groupId': 'OG000'}, {'value': '-49.20', 'spread': '1.940', 'groupId': 'OG001'}, {'value': '-51.67', 'spread': '1.970', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.79', 'ciLowerLimit': '-52.67', 'ciUpperLimit': '-40.91', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.25', 'ciLowerLimit': '-55.18', 'ciUpperLimit': '-43.33', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-11.2', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-13.8', 'spread': '0.51', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.8', 'ciLowerLimit': '-9.2', 'ciUpperLimit': '-6.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.4', 'ciLowerLimit': '-11.8', 'ciUpperLimit': '-8.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares).', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '587', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': 'Pooled 10 mg and 15 mg Tirzepatide', 'description': 'Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.13', 'spread': '1.135', 'groupId': 'OG000'}, {'value': '-2.58', 'spread': '0.755', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.61', 'ciLowerLimit': '-7.11', 'ciUpperLimit': '-2.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and standard error (SE) from MMRM analysis using log transformation.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '587', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': 'Pooled 10 mg and 15 mg Tirzepatide', 'description': 'Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.29', 'spread': '1.874', 'groupId': 'OG000'}, {'value': '2.72', 'spread': '1.264', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.112', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.36', 'ciLowerLimit': '-7.36', 'ciUpperLimit': '0.81', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '587', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': 'Pooled 10 mg and 15 mg Tirzepatide', 'description': 'Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.10', 'spread': '1.048', 'groupId': 'OG000'}, {'value': '8.19', 'spread': '0.782', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.02', 'ciLowerLimit': '4.40', 'ciUpperLimit': '9.71', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '574', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': 'Pooled 10 mg and 15 mg Tirzepatide', 'description': 'Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.0', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '-27.9', 'spread': '1.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.3', 'ciLowerLimit': '-27.5', 'ciUpperLimit': '-18.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '587', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': 'Pooled 10 mg and 15 mg Tirzepatide', 'description': 'Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.8', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '-28.6', 'spread': '1.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.2', 'ciLowerLimit': '-28.6', 'ciUpperLimit': '-19.6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '587', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': 'Pooled Doses of 10 mg and 15 mg Tirzepatide', 'description': 'Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.30', 'spread': '1.573', 'groupId': 'OG000'}, {'value': '-6.64', 'spread': '1.001', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.74', 'ciLowerLimit': '-12.04', 'ciUpperLimit': '-5.32', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Free Fatty Acids (Pooled Doses of 10 mg and 15 mg Tirzepatide)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '586', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': 'Pooled 10 mg and 15 mg Tirzepatide', 'description': 'Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '2.838', 'groupId': 'OG000'}, {'value': '-23.58', 'spread': '1.502', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.61', 'ciLowerLimit': '-28.62', 'ciUpperLimit': '-18.24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '618', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': 'Pooled 10 mg and 15 mg Tirzepatide', 'description': 'Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '0.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.2', 'ciLowerLimit': '-8.0', 'ciUpperLimit': '-4.4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares).', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '618', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': 'Pooled Doses of 10 mg and 15 mg Tirzepatide', 'description': 'Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '-1.3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares).', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.5', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '-29.6', 'spread': '2.28', 'groupId': 'OG001'}, {'value': '-40.3', 'spread': '1.99', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.6', 'ciLowerLimit': '-25.5', 'ciUpperLimit': '-8.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Estimate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.2', 'ciLowerLimit': '-37.0', 'ciUpperLimit': '-22.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '0.40', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '0.7', 'ciUpperLimit': '2.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '1.1', 'ciUpperLimit': '3.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data was imputed using Last Observation Carried Forward (LOCF) method.'}, {'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': '270', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '269', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '15.2', 'spread': '1.03', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.9', 'ciLowerLimit': '4.1', 'ciUpperLimit': '9.7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSMean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '5.0', 'ciUpperLimit': '10.7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'The IWQOL-Lite-CT is a 20-item, obesity-specific patient reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data was imputed using Last Observation Carried Forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.'}, {'id': 'OG001', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.'}], 'classes': [{'categories': [{'measurements': [{'value': '153000', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '234000', 'spread': '19.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 8, 16, 36: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose', 'description': 'Each participant was assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose. The steady state AUC was evaluated using Population PK modeling.', 'unitOfMeasure': 'nanograms*hour per milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered subcutaneously (SC) once weekly (QW).'}, {'id': 'FG001', 'title': '10 Milligrams (mg) Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW'}, {'id': 'FG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '315'}, {'groupId': 'FG001', 'numSubjects': '312'}, {'groupId': 'FG002', 'numSubjects': '311'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '315'}, {'groupId': 'FG001', 'numSubjects': '312'}, {'groupId': 'FG002', 'numSubjects': '311'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '281'}, {'groupId': 'FG001', 'numSubjects': '296'}, {'groupId': 'FG002', 'numSubjects': '282'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Other - As Reported by Investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}, {'value': '938', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received Placebo administered SC QW.'}, {'id': 'BG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10 mg Tirzepatide administered SC QW.'}, {'id': 'BG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15 mg Tirzepatide administered SC QW.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '54.3', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '53.6', 'spread': '10.6', 'groupId': 'BG002'}, {'value': '54.2', 'spread': '10.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}, {'value': '476', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '462', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}, {'value': '561', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '358', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '19', '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': '39', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '710', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '23', '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': 'Argentina', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '346', 'groupId': 'BG003'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '342', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '101.65', 'spread': '22.26', 'groupId': 'BG000'}, {'value': '100.86', 'spread': '20.93', 'groupId': 'BG001'}, {'value': '99.60', 'spread': '20.05', 'groupId': 'BG002'}, {'value': '100.71', 'spread': '21.10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-23', 'size': 2568318, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-13T14:55', 'hasProtocol': True}, {'date': '2023-01-13', 'size': 1312438, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-13T14:55', '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': 938}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-08', 'studyFirstSubmitDate': '2020-12-01', 'resultsFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-08', 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Body Weight', 'timeFrame': 'Baseline, Week 72', 'description': 'Least Squares Mean (LSMean) calculated using Mixed Model Repeated Measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of Antihyperglycemic Medication (AHM) Used at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}, {'measure': 'Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline', 'timeFrame': 'Week 72', 'description': 'Percentage of participants who achieve ≥5% body weight reduction from baseline'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline', 'timeFrame': 'Week 72', 'description': 'Percentage of participants who achieve ≥10% body weight reduction from baseline'}, {'measure': 'Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline', 'timeFrame': 'Week 72', 'description': 'Percentage of participants who achieve ≥15% body weight reduction from baseline'}, {'measure': 'Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline', 'timeFrame': 'Week 72', 'description': 'Percentage of participants who achieve ≥20% body weight reduction from baseline'}, {'measure': 'Change From Baseline in Absolute Body Weight', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}, {'measure': 'Change From Baseline in Body Mass Index (BMI)', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}, {'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}, {'measure': 'Percentage of Participants Who Achieve HbA1c <7%', 'timeFrame': 'Week 72', 'description': 'Percentage of participants who achieve HbA1c \\<7%'}, {'measure': 'Percentage of Participants Who Achieve HbA1c ≤6.5%', 'timeFrame': 'Week 72', 'description': 'Percentage of participants who achieve HbA1c ≤6.5%'}, {'measure': 'Percentage of Participants Who Achieve HbA1c <5.7%', 'timeFrame': 'Week 72', 'description': 'Percentage of participants who achieve HbA1c \\<5.7%'}, {'measure': 'Change From Baseline in Fasting Glucose', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}, {'measure': 'Change From Baseline in Waist Circumference', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}, {'measure': 'Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and standard error (SE) from MMRM analysis using log transformation.'}, {'measure': 'Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.'}, {'measure': 'Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.'}, {'measure': 'Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.'}, {'measure': 'Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.'}, {'measure': 'Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.'}, {'measure': 'Percent Change From Baseline in Free Fatty Acids (Pooled Doses of 10 mg and 15 mg Tirzepatide)', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}, {'measure': 'Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)', 'timeFrame': 'Baseline, Week 72', 'description': 'LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}, {'measure': 'Percent Change From Baseline in Fasting Insulin', 'timeFrame': 'Baseline, Week 72', 'description': 'Results are reported as model-based estimates and SE from MMRM analysis using log transformation.'}, {'measure': 'Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score', 'timeFrame': 'Baseline, Week 72', 'description': 'The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.'}, {'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 is a 20-item, obesity-specific patient reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (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.'}, {'measure': 'Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide', 'timeFrame': 'Week 8, 16, 36: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose', 'description': 'Each participant was assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose. The steady state AUC was evaluated using Population PK modeling.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolism and Nutrition Disorder'], 'conditions': ['Type 2 Diabetes', 'Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '40512543', 'type': 'DERIVED', 'citation': 'Heerspink HJL, Friedman AN, Bjornstad P, van Raalte DH, Cherney D, Cao D, Garcia-Perez LE, Stefanski A, Turfanda I, Bunck MC, Benabbad I, Griffin R, Piras de Oliveira C. Kidney Parameters with Tirzepatide in Obesity with or without Type 2 Diabetes. J Am Soc Nephrol. 2025 Nov 1;36(11):2190-2200. doi: 10.1681/ASN.0000000764. Epub 2025 Jun 13.'}, {'pmid': '40120035', 'type': 'DERIVED', 'citation': 'Hunter Gibble T, Cao D, Zhang XM, Xavier NA, Poon JL, Fitch A. Tirzepatide Was Associated with Improved Health-Related Quality of Life in Adults with Obesity or Overweight and Type 2 Diabetes: Results from the Phase 3 SURMOUNT-2 Trial. Diabetes Ther. 2025 May;16(5):977-991. doi: 10.1007/s13300-025-01723-w. Epub 2025 Mar 22.'}, {'pmid': '37385275', 'type': 'DERIVED', 'citation': 'Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad NN, Bunck MC, Benabbad I, Zhang XM; SURMOUNT-2 investigators. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023 Aug 19;402(10402):613-626. doi: 10.1016/S0140-6736(23)01200-X. Epub 2023 Jun 26.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/6Lso9L1WmsU8ly9DkEFiaU', 'label': 'A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight (SURMOUNT-2)'}]}, 'descriptionModule': {'briefSummary': 'This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)\n* Have a BMI of ≥27 kg/m²\n* Are overweight or have obesity\n* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight\n* Are at least 18 years of age and age of majority per local laws and regulations\n\nExclusion Criteria:\n\n* Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM\n* Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values \\>270 mg/dL(on 2 nonconsecutive days) prior to Visit 3\n* Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment\n* Have self-reported change in body weight \\>5kg within 3 months prior to screening\n* Have had a history of chronic or acute pancreatitis\n* Change in body weight greater than 5 kg within 3 months prior to starting study\n* Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity\n* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)\n* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years\n* Any lifetime history of a suicide attempt'}, 'identificationModule': {'nctId': 'NCT04657003', 'acronym': 'SURMOUNT-2', 'briefTitle': 'A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Efficacy and Safety of Tirzepatide Once Weekly in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-2)', 'orgStudyIdInfo': {'id': '17245'}, 'secondaryIdInfos': [{'id': 'I8F-MC-GPHL', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 milligrams (mg) Tirzepatide', 'description': '10 mg Tirzepatide administered subcutaneously (SC) once weekly (QW)', 'interventionNames': ['Drug: Tirzepatide']}, {'type': 'EXPERIMENTAL', 'label': '15 mg Tirzepatide', 'description': '15 mg Tirzepatide administered SC QW', 'interventionNames': ['Drug: Tirzepatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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': 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