{"protocolSection":{"identificationModule":{"nctId":"NCT05963022","orgStudyIdInfo":{"id":"18746"},"secondaryIdInfos":[{"id":"I8F-MC-GPIU","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)","officialTitle":"A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Tirzepatide Monotherapy Compared With Placebo in Chinese Participants With Type 2 Diabetes"},"statusModule":{"statusVerifiedDate":"2025-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-08-21","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-10-09","type":"ACTUAL"},"completionDateStruct":{"date":"2024-10-09","type":"ACTUAL"},"studyFirstSubmitDate":"2023-07-19","studyFirstSubmitQcDate":"2023-07-19","studyFirstPostDateStruct":{"date":"2023-07-27","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-10-07","resultsFirstSubmitQcDate":"2025-10-07","resultsFirstPostDateStruct":{"date":"2025-10-21","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-10-07","lastUpdatePostDateStruct":{"date":"2025-10-21","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants with Type 2 Diabetes."},"conditionsModule":{"conditions":["Type 2 Diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":206,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"5 Milligram (mg) Tirzepatide","type":"EXPERIMENTAL","description":"Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.","interventionNames":["Drug: Tirzepatide"]},{"label":"10 mg Tirzepatide","type":"EXPERIMENTAL","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.","interventionNames":["Drug: Tirzepatide"]},{"label":"15 mg Tirzepatide","type":"EXPERIMENTAL","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.","interventionNames":["Drug: Tirzepatide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["10 mg Tirzepatide","15 mg Tirzepatide","5 Milligram (mg) Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c)","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 calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Treatment (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 40"}],"secondaryOutcomes":[{"measure":"Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c \\<7.0% (\\<53 mmol/mol) is reported here.","timeFrame":"Week 40"},{"measure":"Change From Baseline in Fasting Serum Glucose","description":"LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c ≤6.5% (≤48 mmol/Mol) is reported here.","timeFrame":"Week 40"},{"measure":"Change From Baseline in Body Weight","description":"LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c \\<5.7% (\\<39 mmol/mol) is reported here.","timeFrame":"Week 40"},{"measure":"Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)","description":"The SMBG data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS Mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Baseline HbA1c (\\<=8.5%, \\>8.5%) + Prior Antihyperglycemic Use + Treatment + Time + Treatment\\*Time(Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants Who Achieved Weight Loss of ≥5%","description":"Percentage of Participants who Achieved Weight Loss ≥5% is reported here.","timeFrame":"Week 40"},{"measure":"Percentage of Participants Who Achieved Weight Loss of ≥10%","description":"Percentage of Participants who Achieved Weight Loss ≥10% is reported here.","timeFrame":"Week 40"},{"measure":"Percentage of Participants Who Achieved Weight Loss of ≥15%","description":"Percentage of Participants who Achieved Weight Loss ≥15% is reported here.","timeFrame":"Week 40"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have Type 2 Diabetes\n* Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol) despite diet and exercise treatment\n* Are of stable weight 5%) during the 90 days preceding screening and agree not to initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment\n* Have Body Mass Index (BMI) ≥23.0 kilogram per square meter (kg/m²)\n\nExclusion Criteria:\n\n* Have Type 1 Diabetes\n* Have a history of chronic or acute pancreatitis any time prior to study entry\n* Are currently receiving treatment for diabetic retinopathy and/or macular edema\n* Have a history of ketoacidosis or hyperosmolar state/coma\n* Have a history of New York Heart Association Functional Classification IV congestive heart failure (CHF)\n* Have acute or chronic hepatitis including a history of autoimmune hepatitis\n* Use of insulin 1-year preceding screening and between screening and baseline; use of any antihyperglycemic medication 90 days preceding screening and between screening and baseline.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Chinese PLA General Hospital","city":"Beijing","state":"Beijing Municipality","zip":"100853","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"Shunde Hospital of Southern Medical Univesity","city":"Foshan","state":"Guangdong","zip":"528399","country":"China","geoPoint":{"lat":23.02677,"lon":113.13148}},{"facility":"Huizhou Municipal Central Hospital","city":"Huizhou","state":"Guangdong","zip":"516001","country":"China","geoPoint":{"lat":23.11147,"lon":114.41523}},{"facility":"Zunyi First People's Hospital","city":"Zunyi","state":"Guizhou","zip":"563002","country":"China","geoPoint":{"lat":27.68667,"lon":106.90722}},{"facility":"Hainan General Hospital","city":"Haikou","state":"Hainan","zip":"570311","country":"China","geoPoint":{"lat":20.03421,"lon":110.34651}},{"facility":"The Fourth Affiliated Hospital of Harbin Medical University","city":"Harbin","state":"Heilongjiang","zip":"150001","country":"China","geoPoint":{"lat":45.75,"lon":126.65}},{"facility":"The First Affiliated Hospital of Henan University of Science &Technology","city":"Luoyang Shi","state":"Henan","zip":"471003","country":"China"},{"facility":"The First Affiliated Hospital of Nanyang Medical College","city":"Nanyang","state":"Henan","zip":"473007","country":"China","geoPoint":{"lat":33.00524,"lon":112.54659}},{"facility":"The Second Affiliated Hospital of Zhengzhou University","city":"Zhengzhou","state":"Henan","zip":"450014","country":"China","geoPoint":{"lat":34.75778,"lon":113.64861}},{"facility":"Yichang Central People's Hospital","city":"Yichang","state":"Hubei","zip":"443003","country":"China","geoPoint":{"lat":30.71444,"lon":111.28472}},{"facility":"The First People's Hospital of Changde City","city":"Changde","state":"Hunan","zip":"415003","country":"China","geoPoint":{"lat":29.03205,"lon":111.69844}},{"facility":"The Second Affiliated Hospital of Nanjing Medical University","city":"Nanjing","state":"Jiangsu","zip":"210011","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"Nanjing First Hospital","city":"Nanjing","state":"Jiangsu","zip":"210012","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"Nanjing Medical University - Nanjing Jiangning Hospital","city":"Nanjing","state":"Jiangsu","zip":"211100","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"The First Affiliated Hospital of Soochow University","city":"Suzhou","state":"Jiangsu","zip":"215006","country":"China","geoPoint":{"lat":31.30408,"lon":120.59538}},{"facility":"Affiliated Hospital of Jiangsu University","city":"Zhenjiang","state":"Jiangsu","zip":"212000","country":"China","geoPoint":{"lat":32.21086,"lon":119.45508}},{"facility":"Jiangxi Pingxiang People's Hospital","city":"Pingxiang","state":"Jiangxi","zip":"337055","country":"China","geoPoint":{"lat":27.61672,"lon":113.85353}},{"facility":"Dalian University - The Affiliated Zhongshan Hospital","city":"Dalian","state":"Liaoning","zip":"116001","country":"China","geoPoint":{"lat":38.91222,"lon":121.60222}},{"facility":"Dalian Municipal Central Hospital Affiliated of Dalian Medical University","city":"Dalian","state":"Liaoning","zip":"116033","country":"China","geoPoint":{"lat":38.91222,"lon":121.60222}},{"facility":"Panjin Liaoyou Baoshihua Hospital","city":"Liaoyou","state":"Liaoning","zip":"124009","country":"China"},{"facility":"The First Affiliated Hospital of Xi'an Medical University","city":"Xi'an","state":"Shaanxi","zip":"710077","country":"China","geoPoint":{"lat":34.25833,"lon":108.92861}},{"facility":"Jinan Central Hospital","city":"Jinan","state":"Shandong","zip":"250013","country":"China","geoPoint":{"lat":36.66833,"lon":116.99722}},{"facility":"Pudong New Area People's Hospital Shanghai","city":"Shanghai","state":"Shanghai Municipality","zip":"201200","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"facility":"Jiading District Central Hospital","city":"Shanghai","state":"Shanghai Municipality","zip":"201800","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"facility":"West China Hospital of Sichuan University","city":"Chengdu","state":"Sichuan","zip":"610041","country":"China","geoPoint":{"lat":30.66667,"lon":104.06667}},{"facility":"Chengdu Fifth People's Hospital","city":"Chengdu","state":"Sichuan","zip":"611130","country":"China","geoPoint":{"lat":30.66667,"lon":104.06667}},{"facility":"Tianjin Medical University General Hospital","city":"Tianjin","state":"Tianjin Municipality","zip":"300052","country":"China","geoPoint":{"lat":39.14222,"lon":117.17667}},{"facility":"Huzhou Central Hospital","city":"Huzhou","state":"Zhejiang","zip":"313000","country":"China","geoPoint":{"lat":30.8703,"lon":120.0933}}]},"referencesModule":{"references":[{"pmid":"42296968","type":"DERIVED","citation":"Yin Y, Ma J, Liu D, Duan W, Cheng Z, Jiang H, Zhang Y, Wu G, Zhuang H, Gu W, Mu Y. Tirzepatide monotherapy in Chinese patients with early type 2 diabetes: A randomized, double-blind, placebo-controlled phase 3 trial (SURPASS-CN-MONO). Med. 2026 Jul 10;7(7):101183. doi: 10.1016/j.medj.2026.101183. Epub 2026 Jun 15."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"http://vivli.org/"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"5 Milligram (mg) Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached."},{"id":"FG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"FG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"FG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"51"},{"groupId":"FG002","numSubjects":"52"},{"groupId":"FG003","numSubjects":"51"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"51"},{"groupId":"FG002","numSubjects":"52"},{"groupId":"FG003","numSubjects":"51"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"46"},{"groupId":"FG002","numSubjects":"48"},{"groupId":"FG003","numSubjects":"47"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Subject Required long-term Initiation of Rescue Antihyperglycemic Medication","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached"},{"id":"BG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"BG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"BG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"51"},{"groupId":"BG002","value":"52"},{"groupId":"BG003","value":"51"},{"groupId":"BG004","value":"206"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.30","spread":"11.37"},{"groupId":"BG001","value":"50.70","spread":"10.79"},{"groupId":"BG002","value":"50.60","spread":"12.11"},{"groupId":"BG003","value":"47.60","spread":"11.56"},{"groupId":"BG004","value":"48.80","spread":"11.54"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"22"},{"groupId":"BG004","value":"90"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"27"},{"groupId":"BG003","value":"29"},{"groupId":"BG004","value":"116"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"51"},{"groupId":"BG002","value":"52"},{"groupId":"BG003","value":"51"},{"groupId":"BG004","value":"206"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"51"},{"groupId":"BG002","value":"52"},{"groupId":"BG003","value":"51"},{"groupId":"BG004","value":"206"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"China","categories":[{"measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"51"},{"groupId":"BG002","value":"52"},{"groupId":"BG003","value":"51"},{"groupId":"BG004","value":"206"}]}]}]},{"title":"Percentage of Hemoglobin A1c (HbA1c) at Baseline","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.07","spread":"0.77"},{"groupId":"BG001","value":"8.13","spread":"0.78"},{"groupId":"BG002","value":"7.97","spread":"0.81"},{"groupId":"BG003","value":"7.92","spread":"0.67"},{"groupId":"BG004","value":"8.02","spread":"0.76"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Hemoglobin A1c (HbA1c)","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 calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Treatment (Type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome, regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached"},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.19","spread":"0.121"},{"groupId":"OG001","value":"-1.75","spread":"0.131"},{"groupId":"OG002","value":"-2.03","spread":"0.124"},{"groupId":"OG003","value":"-0.77","spread":"0.126"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-1.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.76","ciUpperLimit":"-1.07"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-0.98","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.34","ciUpperLimit":"-0.63"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-1.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.61","ciUpperLimit":"-0.92"}]},{"type":"SECONDARY","title":"Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c \\<7.0% (\\<53 mmol/mol) is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached"},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"90.38"},{"groupId":"OG001","value":"86.36"},{"groupId":"OG002","value":"83.33"},{"groupId":"OG003","value":"38.30"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"17.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"5.62","ciUpperLimit":"51.73"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"7.51","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.77","ciUpperLimit":"20.37"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"7.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.74","ciUpperLimit":"19.14"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Serum Glucose","description":"LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment (Type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome, regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligram per deciliter (mg/dL)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached"},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-55.0","spread":"3.00"},{"groupId":"OG001","value":"-54.8","spread":"3.16"},{"groupId":"OG002","value":"-55.4","spread":"3.06"},{"groupId":"OG003","value":"-30.2","spread":"3.07"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-24.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-33.3","ciUpperLimit":"-16.3"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-24.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-33.2","ciUpperLimit":"-15.9"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-25.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-33.7","ciUpperLimit":"-16.7"}]},{"type":"SECONDARY","title":"Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c ≤6.5% (≤48 mmol/Mol) is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached"},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"88.46"},{"groupId":"OG001","value":"75.00"},{"groupId":"OG002","value":"81.25"},{"groupId":"OG003","value":"23.40"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"25.61","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"8.70","ciUpperLimit":"75.36"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"7.25","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.88","ciUpperLimit":"18.25"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"10.95","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.23","ciUpperLimit":"28.34"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (\\<=8.5%, \\>8.5%) + Treatment (Type III sum of squares) as variables.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome, regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms (kg)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached"},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.1","spread":"0.68"},{"groupId":"OG001","value":"-5.5","spread":"0.71"},{"groupId":"OG002","value":"-8.7","spread":"0.69"},{"groupId":"OG003","value":"-1.3","spread":"0.70"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-4.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.7","ciUpperLimit":"-2.9"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-4.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.2","ciUpperLimit":"-2.3"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference","paramValue":"-7.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.3","ciUpperLimit":"-5.4"}]},{"type":"SECONDARY","title":"Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c \\<5.7% (\\<39 mmol/mol) is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached"},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"40.38"},{"groupId":"OG001","value":"34.09"},{"groupId":"OG002","value":"56.25"},{"groupId":"OG003","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.003","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"76.62","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.40","ciUpperLimit":"1333.29"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"49.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.80","ciUpperLimit":"868.67"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"118.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"6.80","ciUpperLimit":"2055.04"}]},{"type":"SECONDARY","title":"Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)","description":"The SMBG data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS Mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Baseline HbA1c (\\<=8.5%, \\>8.5%) + Prior Antihyperglycemic Use + Treatment + Time + Treatment\\*Time(Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome regardless of adherence to study drug or initiation of rescue antihyperglycemic medication.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligram per deciliter (mg/dL)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached"},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"45"},{"groupId":"OG002","value":"43"},{"groupId":"OG003","value":"27"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-78.4","spread":"3.959"},{"groupId":"OG001","value":"-78.3","spread":"4.185"},{"groupId":"OG002","value":"-80.8","spread":"4.186"},{"groupId":"OG003","value":"-33.9","spread":"5.223"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-44.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-57.5","ciUpperLimit":"-31.5"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-44.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-57.6","ciUpperLimit":"-31.1"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-46.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-60.1","ciUpperLimit":"-33.7"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss of ≥5%","description":"Percentage of Participants who Achieved Weight Loss ≥5% is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached"},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"45"},{"groupId":"OG002","value":"43"},{"groupId":"OG003","value":"27"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"54.90"},{"groupId":"OG001","value":"66.67"},{"groupId":"OG002","value":"88.37"},{"groupId":"OG003","value":"7.41"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"18.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"5.27","ciUpperLimit":"62.73"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"30.96","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"8.87","ciUpperLimit":"108.05"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"73.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"19.36","ciUpperLimit":"278.40"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss of ≥10%","description":"Percentage of Participants who Achieved Weight Loss ≥10% is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached"},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"45"},{"groupId":"OG002","value":"43"},{"groupId":"OG003","value":"27"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27.45"},{"groupId":"OG001","value":"33.33"},{"groupId":"OG002","value":"58.14"},{"groupId":"OG003","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.011","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"39.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.29","ciUpperLimit":"664.36"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.005","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"56.34","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.34","ciUpperLimit":"949.59"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"127.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"7.58","ciUpperLimit":"2145.42"}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss of ≥15%","description":"Percentage of Participants who Achieved Weight Loss ≥15% is reported here.","populationDescription":"All randomized participants who received at least one dose of study drug and had evaluable data for this outcome.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached"},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.\n\nThe starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached."},{"id":"OG003","title":"Placebo","description":"Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"45"},{"groupId":"OG002","value":"43"},{"groupId":"OG003","value":"27"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.80"},{"groupId":"OG001","value":"13.33"},{"groupId":"OG002","value":"37.21"},{"groupId":"OG003","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.077","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"13.86","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.75","ciUpperLimit":"254.78"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.062","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio 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