Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-29 @ 10:41 AM
Study NCT ID:
NCT03954834
Status:
COMPLETED
Last Update Posted:
2021-10-20
First Post:
2019-05-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
Sponsor:
Organization:
Raw JSON
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'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 to end of Safety follow-up (up to 44 weeks)', 'description': 'All randomized participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg of Tirzepatide as subcutaneous injection, once weekly.', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 50, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, 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'EG001', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 15, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 31, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 82, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 50, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 31, 'numAffected': 31}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo as subcutaneous injection once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.87', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '-1.89', 'spread': '0.096', 'groupId': 'OG001'}, {'value': '-2.07', 'spread': '0.098', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.105', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.91', 'ciLowerLimit': '-2.18', 'ciUpperLimit': '-1.63', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.93', 'ciLowerLimit': '-2.21', 'ciUpperLimit': '-1.65', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.11', 'ciLowerLimit': '-2.39', 'ciUpperLimit': '-1.83', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 40', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Prior Use of oral antihyperglycemic medication (OAM) (Yes, No) + 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 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo as subcutaneous injection once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.0', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '-9.5', 'spread': '0.54', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.57', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.3', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '-4.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.1', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '-5.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.8', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '-7.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 40', 'description': 'Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Prior Use of OAM (Yes, No) + 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 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c Target Value of <7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo as subcutaneous injection once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.78', 'groupId': 'OG000'}, {'value': '91.53', 'groupId': 'OG001'}, {'value': '87.93', 'groupId': 'OG002'}, {'value': '19.64', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.00', 'ciLowerLimit': '21.12', 'ciUpperLimit': '113.67', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '80.39', 'ciLowerLimit': '31.80', 'ciUpperLimit': '203.19', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '52.95', 'ciLowerLimit': '22.30', 'ciUpperLimit': '125.73', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40', 'description': 'Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Serum Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo as subcutaneous injection once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.6', 'spread': '3.40', 'groupId': 'OG000'}, {'value': '-45.9', 'spread': '3.45', 'groupId': 'OG001'}, {'value': '-49.3', 'spread': '3.62', 'groupId': 'OG002'}, {'value': '12.9', 'spread': '4.00', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.776', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-11.9', 'ciUpperLimit': '8.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.622', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-13.0', 'ciUpperLimit': '7.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.908', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-11.1', 'ciUpperLimit': '9.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 40', 'description': 'Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).', 'unitOfMeasure': 'milligram per Deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c Target Value of <5.7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo as subcutaneous injection once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.88', 'groupId': 'OG000'}, {'value': '30.51', 'groupId': 'OG001'}, {'value': '51.72', 'groupId': 'OG002'}, {'value': '0.89', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.28', 'ciLowerLimit': '7.74', 'ciUpperLimit': '209.71', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.12', 'ciLowerLimit': '6.53', 'ciUpperLimit': '178.19', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '85.13', 'ciLowerLimit': '16.36', 'ciUpperLimit': '443.13', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40', 'description': 'Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo as subcutaneous injection once a week.'}], 'classes': [{'title': 'Morning Premeal - Fasting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-46.9', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '-47.9', 'spread': '2.11', 'groupId': 'OG001'}, {'value': '-45.7', 'spread': '2.23', 'groupId': 'OG002'}, {'value': '-9.2', 'spread': '2.53', 'groupId': 'OG003'}]}]}, {'title': 'Morning 2-hour Postmeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-69.5', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '-61.4', 'spread': '3.44', 'groupId': 'OG001'}, {'value': '-68.9', 'spread': '3.66', 'groupId': 'OG002'}, {'value': '-11.6', 'spread': '4.12', 'groupId': 'OG003'}]}]}, {'title': 'Midday Premeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-43.5', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '-42.5', 'spread': '2.82', 'groupId': 'OG001'}, {'value': '-42.7', 'spread': '3.00', 'groupId': 'OG002'}, {'value': '-2.6', 'spread': '3.42', 'groupId': 'OG003'}]}]}, {'title': 'Midday 2-hour Postmeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-64.2', 'spread': '3.60', 'groupId': 'OG000'}, {'value': '-60.0', 'spread': '3.63', 'groupId': 'OG001'}, {'value': '-63.4', 'spread': '3.84', 'groupId': 'OG002'}, {'value': '-12.7', 'spread': '4.33', 'groupId': 'OG003'}]}]}, {'title': 'Evening Premeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-44.8', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '-45.1', 'spread': '2.82', 'groupId': 'OG001'}, {'value': '-42.3', 'spread': '3.02', 'groupId': 'OG002'}, {'value': '-5.8', 'spread': '3.38', 'groupId': 'OG003'}]}]}, {'title': 'Evening 2-hour Postmeal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-61.9', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '-62.8', 'spread': '3.81', 'groupId': 'OG001'}, {'value': '-63.5', 'spread': '4.03', 'groupId': 'OG002'}, {'value': '-10.3', 'spread': '4.52', 'groupId': 'OG003'}]}]}, {'title': 'Bedtime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-57.0', 'spread': '3.49', 'groupId': 'OG000'}, {'value': '-59.8', 'spread': '3.52', 'groupId': 'OG001'}, {'value': '-60.8', 'spread': '3.66', 'groupId': 'OG002'}, {'value': '-9.1', 'spread': '4.10', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.7', 'ciLowerLimit': '-44.1', 'ciUpperLimit': '-31.2', 'groupDescription': 'Morning Premeal - Fasting', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.6', 'ciLowerLimit': '-45.1', 'ciUpperLimit': '-32.2', 'groupDescription': 'Morning Premeal - Fasting', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.5', 'ciLowerLimit': '-43.1', 'ciUpperLimit': '-29.8', 'groupDescription': 'Morning Premeal - Fasting', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-57.9', 'ciLowerLimit': '-68.4', 'ciUpperLimit': '-47.4', 'groupDescription': 'Morning 2-hour Postmeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.7', 'ciLowerLimit': '-60.3', 'ciUpperLimit': '-39.2', 'groupDescription': 'Morning 2-hour Postmeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-57.3', 'ciLowerLimit': '-68.1', 'ciUpperLimit': '-46.4', 'groupDescription': 'Morning 2-hour Postmeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.9', 'ciLowerLimit': '-49.6', 'ciUpperLimit': '-32.2', 'groupDescription': 'Midday Premeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.9', 'ciLowerLimit': '-48.6', 'ciUpperLimit': '-31.2', 'groupDescription': 'Midday Premeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.0', 'ciLowerLimit': '-49.0', 'ciUpperLimit': '-31.1', 'groupDescription': 'Midday Premeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-51.4', 'ciLowerLimit': '-62.5', 'ciUpperLimit': '-40.4', 'groupDescription': 'Midday 2-hour Postmeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.3', 'ciLowerLimit': '-58.4', 'ciUpperLimit': '-36.2', 'groupDescription': 'Midday 2-hour Postmeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.7', 'ciLowerLimit': '-62.1', 'ciUpperLimit': '-39.3', 'groupDescription': 'Midday 2-hour Postmeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.0', 'ciLowerLimit': '-47.6', 'ciUpperLimit': '-30.4', 'groupDescription': 'Evening Premeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.2', 'ciLowerLimit': '-47.9', 'ciUpperLimit': '-30.6', 'groupDescription': 'Evening Premeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.4', 'ciLowerLimit': '-45.3', 'ciUpperLimit': '-27.5', 'groupDescription': 'Evening Premeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-51.7', 'ciLowerLimit': '-63.2', 'ciUpperLimit': '-40.1', 'groupDescription': 'Evening 2-hour Postmeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.5', 'ciLowerLimit': '-64.1', 'ciUpperLimit': '-40.9', 'groupDescription': 'Evening 2-hour Postmeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-53.2', 'ciLowerLimit': '-65.1', 'ciUpperLimit': '-41.3', 'groupDescription': 'Evening 2-hour Postmeal', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-48.0', 'ciLowerLimit': '-58.6', 'ciUpperLimit': '-37.4', 'groupDescription': 'Bedtime', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.7', 'ciLowerLimit': '-61.3', 'ciUpperLimit': '-40.1', 'groupDescription': 'Bedtime', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-51.7', 'ciLowerLimit': '-62.6', 'ciUpperLimit': '-40.9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 40', 'description': 'The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Weight Loss ≥5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo as subcutaneous injection once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.94', 'groupId': 'OG000'}, {'value': '77.97', 'groupId': 'OG001'}, {'value': '76.72', 'groupId': 'OG002'}, {'value': '14.29', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.40', 'ciLowerLimit': '6.43', 'ciUpperLimit': '23.94', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.13', 'ciLowerLimit': '10.59', 'ciUpperLimit': '42.18', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.10', 'ciLowerLimit': '10.09', 'ciUpperLimit': '40.04', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 40', 'description': 'Percentage of Participants who Achieved Weight Loss ≥5%.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.'}, {'type': 'SECONDARY', 'title': 'Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo as subcutaneous injection once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.002', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.002', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.002', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.028', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through end of safety follow-up (up to week 44)', 'description': 'The hypoglycemia events were defined by participant reported events with blood glucose \\<54mg/dL) (\\<3.0 mmol/L\\] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Prior Use of OAM (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable.', 'unitOfMeasure': 'Episodes/participant/365.25 days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'OG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15mg of tirzepatide as subcutaneous injection once a week.'}], 'classes': [{'categories': [{'measurements': [{'value': '86900', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '171000', 'spread': '26.2', 'groupId': 'OG001'}, {'value': '252000', 'spread': '23.3', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 7, 15 and 23', 'description': 'Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide. AUC is a combined measure obtained from Week 7, 15 and 23, and a single averaged measure of AUC was reported.', 'unitOfMeasure': 'nanograms*hours per milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'FG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'FG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received placebo as subcutaneous injection once a week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '121'}, {'groupId': 'FG002', 'numSubjects': '121'}, {'groupId': 'FG003', 'numSubjects': '115'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '121'}, {'groupId': 'FG002', 'numSubjects': '121'}, {'groupId': 'FG003', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '112'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Participant left the country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '478', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'BG001', 'title': '10 mg Tirzepatide', 'description': 'Participants received 10mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'BG002', 'title': '15 mg Tirzepatide', 'description': 'Participants received 15mg of tirzepatide as subcutaneous injection once a week.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received placebo as subcutaneous injection once a week.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.10', 'spread': '11.88', 'groupId': 'BG000'}, {'value': '55.80', 'spread': '10.35', 'groupId': 'BG001'}, {'value': '52.90', 'spread': '12.34', 'groupId': 'BG002'}, {'value': '53.60', 'spread': '12.79', 'groupId': 'BG003'}, {'value': '54.10', 'spread': '11.88', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '231', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '247', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '207', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '184', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '168', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '170', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'India', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '89', 'groupId': 'BG004'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '164', 'groupId': 'BG004'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '140', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '7.97', 'spread': '0.841', 'groupId': 'BG000'}, {'value': '7.90', 'spread': '0.78', 'groupId': 'BG001'}, {'value': '7.85', 'spread': '1.02', 'groupId': 'BG002'}, {'value': '8.05', 'spread': '0.80', 'groupId': 'BG003'}, {'value': '7.94', 'spread': '0.87', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-15', 'size': 8331883, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-14T00:31', 'hasProtocol': True}, {'date': '2020-11-20', 'size': 6256274, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-14T00:30', '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': 478}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-18', 'studyFirstSubmitDate': '2019-05-15', 'resultsFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-18', 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, Week 40', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Prior Use of oral antihyperglycemic medication (OAM) (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline, Week 40', 'description': 'Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}, {'measure': 'Percentage of Participants With HbA1c Target Value of <7%', 'timeFrame': 'Week 40', 'description': 'Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.'}, {'measure': 'Change From Baseline in Fasting Serum Glucose', 'timeFrame': 'Baseline, Week 40', 'description': 'Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}, {'measure': 'Percentage of Participants With HbA1c Target Value of <5.7%', 'timeFrame': 'Week 40', 'description': 'Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.'}, {'measure': 'Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values', 'timeFrame': 'Baseline, Week 40', 'description': 'The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment\\*Time (Type III sum of squares).'}, {'measure': 'Percentage of Participants Who Achieved Weight Loss ≥5%', 'timeFrame': 'Week 40', 'description': 'Percentage of Participants who Achieved Weight Loss ≥5%.'}, {'measure': 'Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia', 'timeFrame': 'Baseline through end of safety follow-up (up to week 44)', 'description': 'The hypoglycemia events were defined by participant reported events with blood glucose \\<54mg/dL) (\\<3.0 mmol/L\\] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Prior Use of OAM (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable.'}, {'measure': 'Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide', 'timeFrame': 'Week 7, 15 and 23', 'description': 'Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide. AUC is a combined measure obtained from Week 7, 15 and 23, and a single averaged measure of AUC was reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glucose-dependent insulinotropic polypeptide (GIP)', 'glucagon-like peptide-1 (GLP-1)', 'GIP/GLP-1 dual receptor agonist', 'T2DM'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '39531161', 'type': 'DERIVED', 'citation': 'De Block C, Peleshok J, Wilding JPH, Kwan AYM, Rasouli N, Maldonado JM, Wysham C, Liu M, Aleppo G, Benneyworth BD. Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics. Diabetes Ther. 2025 Jan;16(1):43-71. doi: 10.1007/s13300-024-01660-0. Epub 2024 Nov 12.'}, {'pmid': '37668888', 'type': 'DERIVED', 'citation': 'Boye KS, Sapin H, Dong W, Williamson S, Lee CJ, Thieu VT. Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide. Diabetes Ther. 2023 Nov;14(11):1867-1887. doi: 10.1007/s13300-023-01457-7. Epub 2023 Sep 5.'}, {'pmid': '37526908', 'type': 'DERIVED', 'citation': 'Boye KS, Thieu VT, Sapin H, Lee CJ, Lando LF, Brown K, Bray R, Wiese RJ, Patel H, Rodriguez A, Yu M. Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Diabetes Ther. 2023 Nov;14(11):1833-1852. doi: 10.1007/s13300-023-01451-z. Epub 2023 Aug 1.'}, {'pmid': '35210595', 'type': 'DERIVED', 'citation': 'Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.'}, {'pmid': '34186022', 'type': 'DERIVED', 'citation': 'Rosenstock J, Wysham C, Frias JP, Kaneko S, Lee CJ, Fernandez Lando L, Mao H, Cui X, Karanikas CA, Thieu VT. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021 Jul 10;398(10295):143-155. doi: 10.1016/S0140-6736(21)01324-6. Epub 2021 Jun 27.'}], 'seeAlsoLinks': [{'url': 'https://www.lillytrialguide.com/en-US/studies/adult-type-2-diabetes/GPGK#?postal=', 'label': 'A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone (SURPASS-1)'}]}, 'descriptionModule': {'briefSummary': 'The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been diagnosed with type 2 diabetes mellitus (T2DM).\n* Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.\n* Have HbA1c between ≥7.0% and ≤9.5%.\n* Be of stable weight (± 5%) for at least 3 months before screening.\n* Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.\n\nExclusion Criteria:\n\n* Have type 1 diabetes mellitus.\n* Have had chronic or acute pancreatitis any time prior to study entry.\n* Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.\n* Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.\n* Have an estimated glomerular filtration rate \\<30 mL/minute/1.73 m².\n* Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.\n* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.\n* Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.'}, 'identificationModule': {'nctId': 'NCT03954834', 'acronym': 'SURPASS-1', 'briefTitle': 'A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Three Tirzepatide Doses Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone', 'orgStudyIdInfo': {'id': '17000'}, 'secondaryIdInfos': [{'id': 'I8F-MC-GPGK', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5 mg Tirzepatide', 'description': 'Participants received 5 milligrams (mg) of tirzepatide as subcutaneous injection once a week.', 'interventionNames': ['Drug: Tirzepatide']}, {'type': 'EXPERIMENTAL', 'label': '10 mg Tirzepatide', 'description': 'Participants received 10mg of tirzepatide as subcutaneous injection once a week.', 'interventionNames': ['Drug: Tirzepatide']}, {'type': 'EXPERIMENTAL', 'label': '15 mg Tirzepatide', 'description': 'Participants received 15mg of tirzepatide as subcutaneous injection once a week.', 'interventionNames': ['Drug: Tirzepatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo as subcutaneous injection once a week.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tirzepatide', 'type': 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