{"protocolSection":{"identificationModule":{"nctId":"NCT04039503","orgStudyIdInfo":{"id":"16998"},"secondaryIdInfos":[{"id":"I8F-MC-GPGI","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2019-000860-99","type":"EUDRACT_NUMBER"},{"id":"2019","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2019"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin","officialTitle":"Randomized, Phase 3, Double-blind Trial Comparing the Effect of the Addition of Tirzepatide Versus Placebo in Patients With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin","acronym":"SURPASS-5"},"statusModule":{"statusVerifiedDate":"2021-12-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-08-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-12-22","type":"ACTUAL"},"completionDateStruct":{"date":"2021-01-13","type":"ACTUAL"},"studyFirstSubmitDate":"2019-07-30","studyFirstSubmitQcDate":"2019-07-30","studyFirstPostDateStruct":{"date":"2019-07-31","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-12-12","resultsFirstSubmitQcDate":"2021-12-12","resultsFirstPostDateStruct":{"date":"2022-01-12","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-12-12","lastUpdatePostDateStruct":{"date":"2022-01-12","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits."},"conditionsModule":{"conditions":["Type 2 Diabetes"],"keywords":["glucose-dependent insulinotropic polypeptide (GIP)","glucagon-like peptide-1 (GLP-1)","GIP/GLP-1 dual receptor agonist","T2DM"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":475,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"5 mg Tirzepatide","type":"EXPERIMENTAL","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.","interventionNames":["Drug: Tirzepatide"]},{"label":"10 mg Tirzepatide","type":"EXPERIMENTAL","description":"10 mg tirzepatide administered SC once a week.","interventionNames":["Drug: Tirzepatide"]},{"label":"15 mg Tirzepatide","type":"EXPERIMENTAL","description":"15 mg tirzepatide administered SC once a week.","interventionNames":["Drug: Tirzepatide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo administered SC once a week.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC as add-on to the pre-trial background medication.","armGroupLabels":["10 mg Tirzepatide","15 mg Tirzepatide","5 mg Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Placebo","description":"Administered SC as add-on to the pre-trial background medication.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)","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 + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 40"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c (5 mg)","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 + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 40"},{"measure":"Change From Baseline in Body Weight","description":"Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline HbA1c Group (\\<= 8.0%, \\>8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants Achieving an HbA1c Target Value of <7%","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.","timeFrame":"Week 40"},{"measure":"Change From Baseline in Fasting Serum Glucose","description":"Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS Mean was determined by MMRM model with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\\<= 8.0%, \\>8.0%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 40"},{"measure":"Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values","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 + Baseline HbA1c Group (\\<= 8.0%, \\>8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment (Type III sum of squares).","timeFrame":"Baseline, Week 40"},{"measure":"Percentage of Participants Who Achieved Weight Loss ≥5%","description":"Percentage of Participants who Achieved Weight Loss ≥5%.","timeFrame":"Week 40"},{"measure":"Percentage Change From Baseline in Daily Mean Insulin Glargine Dose","description":"LS mean was calculated using MMRM model with log (Baseline) + Baseline Metformin Use (Yes, No) + Pooled Country + Baseline HbA1c Group (\\<= 8.0%, \\>8.0%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 40"},{"measure":"Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia","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 Metformin Use (Yes, No) + Baseline HbA1c Group (\\<= 8.0%, \\>8.0%) + Treatment, with log (exposure in days/365.25) as an offset variable.","timeFrame":"Baseline through Safety Follow-Up (Up to Week 44)"},{"measure":"Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide","description":"AUC is a combined measure obtained from Week 7, 15, 23 and 39 and a single averaged measure of AUC was reported.","timeFrame":"Week 7, 15, 23 and 39 post dose"},{"measure":"Percentage of Participants Achieving an HbA1c Target Value of <5.7%","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.","timeFrame":"Week 40"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with insulin glargine (U100), once daily with or without metformin ≥3 months prior to screening visit.\n* Have HbA1c between ≥7.0% and ≤10.5%.\n* Have a stable weight (± 5%) for at least 3 months before screening.\n* Have a body mass index (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 \\[for participants on metformin, estimated glomerular filtration rate \\<45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\\]\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.","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":"Valley Endocrine, Fresno","city":"Fresno","state":"California","zip":"93720","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"Sun Coast Clinical Research, Inc","city":"New Port Richey","state":"Florida","zip":"34652","country":"United States","geoPoint":{"lat":28.24418,"lon":-82.71927}},{"facility":"Southern New Hampshire Diabetes and Endocrinology","city":"Nashua","state":"New Hampshire","zip":"03063","country":"United States","geoPoint":{"lat":42.76537,"lon":-71.46757}},{"facility":"Manhattan Medical Research","city":"New York","state":"New York","zip":"10016","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Intend Research","city":"Norman","state":"Oklahoma","zip":"73069","country":"United States","geoPoint":{"lat":35.22257,"lon":-97.43948}},{"facility":"Milan Kvapil s.r.o.","city":"Příbram","state":"Central Bohemia","zip":"26201","country":"Czechia","geoPoint":{"lat":49.68988,"lon":14.01043}},{"facility":"Diacentrum Brandys n.L. s.r.o.","city":"Brandys Nad Labem-Stara Bolesl","zip":"25001","country":"Czechia"},{"facility":"Diabetologicka ordinace pro dospele","city":"Krnov","zip":"79401","country":"Czechia","geoPoint":{"lat":50.08967,"lon":17.70385}},{"facility":"Diahelp s.r.o., Interni a diabetologicka ambulance","city":"Pardubice","zip":"53002","country":"Czechia","geoPoint":{"lat":50.04075,"lon":15.77659}},{"facility":"Lekarna Dr. Max","city":"Prague","zip":"11000","country":"Czechia","geoPoint":{"lat":50.08804,"lon":14.42076}},{"facility":"Milan Kvapil s.r.o.","city":"Prague","zip":"149 00","country":"Czechia","geoPoint":{"lat":50.08804,"lon":14.42076}},{"facility":"RESTRIAL s.r.o.","city":"Prague","zip":"181 00","country":"Czechia","geoPoint":{"lat":50.08804,"lon":14.42076}},{"facility":"Praxis Dr. Jörg Lüdemann","city":"Falkensee","state":"Brandenburg","zip":"14612","country":"Germany","geoPoint":{"lat":52.56014,"lon":13.0927}},{"facility":"Arztpraxis Dr. Cornelia Marck","city":"Pohlheim","state":"Hesse","zip":"35415","country":"Germany"},{"facility":"InnoDiab Forschung GmbH","city":"Essen","state":"North Rhine-Westphalia","zip":"45136","country":"Germany","geoPoint":{"lat":51.45657,"lon":7.01228}},{"facility":"Institut für Diabetesforschung Münster GmbH","city":"Münster","state":"North Rhine-Westphalia","zip":"48145","country":"Germany","geoPoint":{"lat":51.96236,"lon":7.62571}},{"facility":"Praxis Dr. Kempe - Dr. Stemler","city":"Ludwigshafen am Rhein","state":"Rhineland-Palatinate","zip":"67059","country":"Germany","geoPoint":{"lat":49.48121,"lon":8.44641}},{"facility":"Schwerpunktpraxis Diabetes","city":"Saint Ingbert-Oberwürzbach","state":"Saarland","zip":"66386","country":"Germany"},{"facility":"SMO.MD GmbH","city":"Magdeburg","state":"Saxony-Anhalt","zip":"39112","country":"Germany","geoPoint":{"lat":52.13129,"lon":11.63189}},{"facility":"RED-Institut GmbH","city":"Oldenburg in Holstein","state":"Schleswig-Holstein","zip":"23758","country":"Germany","geoPoint":{"lat":54.29498,"lon":10.89043}},{"facility":"Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen","city":"Hamburg","zip":"21073","country":"Germany","geoPoint":{"lat":53.55073,"lon":9.99302}},{"facility":"Gemeinschaftspraxis für innere Medizin und Diabetologie","city":"Hamburg","zip":"22607","country":"Germany","geoPoint":{"lat":53.55073,"lon":9.99302}},{"facility":"Kashiwa hospital","city":"Kashiwa","state":"Chiba","zip":"277-0825","country":"Japan","geoPoint":{"lat":35.86224,"lon":139.97732}},{"facility":"Manda Hospital","city":"Sapporo","state":"Hokkaido","zip":"060-0062","country":"Japan","geoPoint":{"lat":43.06667,"lon":141.35}},{"facility":"Takai Naika Clinic","city":"Kamakura","state":"Kanagawa","zip":"247-0056","country":"Japan","geoPoint":{"lat":35.31085,"lon":139.54698}},{"facility":"Takatsuki Red Cross Hospital","city":"Takatsuki","state":"Osaka","zip":"569-1096","country":"Japan","geoPoint":{"lat":34.84833,"lon":135.61678}},{"facility":"Tokyo-Eki Center-building Clinic","city":"Chuo-ku","state":"Tokyo","zip":"103-0027","country":"Japan"},{"facility":"Tokyo Center Clinic","city":"Chuo-ku","state":"Tokyo","zip":"103-0028","country":"Japan"},{"facility":"Tokyo Clinical Trial Centre Fukuwa Clinic","city":"Chuo-ku","state":"Tokyo","zip":"104-0031","country":"Japan"},{"facility":"The Institute for Adult Diseases, Asahi Life Foundation","city":"Chuou-ku","state":"Tokyo","zip":"1030002","country":"Japan"},{"facility":"Sato Naika Clinic","city":"Ōta-ku","state":"Tokyo","zip":"143-0015","country":"Japan","geoPoint":{"lat":35.56126,"lon":139.71605}},{"facility":"Jinnouchi Hospital","city":"Kumamoto","zip":"862-0976","country":"Japan","geoPoint":{"lat":32.80589,"lon":130.69181}},{"facility":"Centrum Medyczne AMED","city":"Warsaw","state":"Masovian Voivodeship","zip":"01-518","country":"Poland","geoPoint":{"lat":52.22977,"lon":21.01178}},{"facility":"NZOZ ZDROWIE Osteo-Medic","city":"Bialystok","state":"Podlaskie Voivodeship","zip":"15-351","country":"Poland","geoPoint":{"lat":53.13333,"lon":23.16433}},{"facility":"Centrum Badan Klinicznych, PI House","city":"Gdansk","state":"Pomeranian Voivodeship","zip":"80-546","country":"Poland","geoPoint":{"lat":54.35227,"lon":18.64912}},{"facility":"NZOZ Przychodnia Specjalistyczna MEDICA","city":"Lublin","zip":"20-538","country":"Poland","geoPoint":{"lat":51.25058,"lon":22.57009}},{"facility":"Centro de Endocrinologia y Nutricion del Turabo","city":"Caguas","state":"PR","zip":"00725","country":"Puerto Rico","geoPoint":{"lat":18.23412,"lon":-66.0485}},{"facility":"Manati Center for Clinical Research Inc","city":"Manati","state":"PR","zip":"00674","country":"Puerto Rico","geoPoint":{"lat":18.42745,"lon":-66.49212}},{"facility":"Ambulancia vnútorného lekárstva Hnúša (Diabetes care)","city":"Hnúšťa","zip":"98101","country":"Slovakia","geoPoint":{"lat":48.57257,"lon":19.95395}},{"facility":"Sin Azucar","city":"Malacky","zip":"901 01","country":"Slovakia","geoPoint":{"lat":48.43604,"lon":17.02188}},{"facility":"Dia-Clarus.s.r.o.","city":"Prievidza","zip":"971 01","country":"Slovakia","geoPoint":{"lat":48.77446,"lon":18.6275}},{"facility":"JAL","city":"Trnava","zip":"917 01","country":"Slovakia","geoPoint":{"lat":48.37773,"lon":17.58603}},{"facility":"Medivasa, s.r.o.","city":"Žilina","zip":"01001","country":"Slovakia","geoPoint":{"lat":49.22315,"lon":18.73941}},{"facility":"Hospital Clinico Universitario Virgen de la Victoria","city":"Málaga","state":"Andalusia","zip":"29010","country":"Spain","geoPoint":{"lat":36.72016,"lon":-4.42034}},{"facility":"Hospital de la Ribera","city":"Alzira","state":"Valencia","zip":"46600","country":"Spain","geoPoint":{"lat":39.15,"lon":-0.43333}},{"facility":"Hospital Universitario Virgen Macarena","city":"Seville","zip":"41009","country":"Spain","geoPoint":{"lat":37.38283,"lon":-5.97317}},{"facility":"Hospital Infanta Luisa","city":"Seville","zip":"41010","country":"Spain","geoPoint":{"lat":37.38283,"lon":-5.97317}},{"facility":"Hospital Universitari i Politecnic La Fe-ENDO","city":"Valencia","zip":"46026","country":"Spain","geoPoint":{"lat":39.47391,"lon":-0.37966}}]},"referencesModule":{"references":[{"pmid":"41961454","type":"DERIVED","citation":"Bajaj HS, Billings LK, Sharma P, Levine JA, Rodriguez A, Patel H. Tirzepatide as an Add-on for Participants with Inadequate Glycemic Control Using Basal Insulin: Pooled Subgroup Analysis of SURPASS-5 and -6. Diabetes Ther. 2026 May;17(5):787-797. doi: 10.1007/s13300-026-01859-3. Epub 2026 Apr 10."},{"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":"35133415","type":"DERIVED","citation":"Dahl D, Onishi Y, Norwood P, Huh R, Bray R, Patel H, Rodriguez A. Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial. JAMA. 2022 Feb 8;327(6):534-545. doi: 10.1001/jama.2022.0078."}],"seeAlsoLinks":[{"label":"A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin","url":"https://trials.lillytrialguide.com/en-US/trial/33Mn9pqfndRwZEPVvpNxDR"}]},"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 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 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"FG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"FG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"FG003","title":"Placebo","description":"Placebo administered SC once a week."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"116"},{"groupId":"FG001","numSubjects":"119"},{"groupId":"FG002","numSubjects":"120"},{"groupId":"FG003","numSubjects":"120"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"116"},{"groupId":"FG001","numSubjects":"119"},{"groupId":"FG002","numSubjects":"120"},{"groupId":"FG003","numSubjects":"120"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"109"},{"groupId":"FG001","numSubjects":"115"},{"groupId":"FG002","numSubjects":"110"},{"groupId":"FG003","numSubjects":"117"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"BG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"BG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"BG003","title":"Placebo","description":"Placebo administered SC once a week."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"116"},{"groupId":"BG001","value":"119"},{"groupId":"BG002","value":"120"},{"groupId":"BG003","value":"120"},{"groupId":"BG004","value":"475"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"61.50","spread":"9.81"},{"groupId":"BG001","value":"60.40","spread":"10.24"},{"groupId":"BG002","value":"60.50","spread":"9.92"},{"groupId":"BG003","value":"60.00","spread":"9.63"},{"groupId":"BG004","value":"60.60","spread":"9.88"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"55"},{"groupId":"BG001","value":"47"},{"groupId":"BG002","value":"55"},{"groupId":"BG003","value":"54"},{"groupId":"BG004","value":"211"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"61"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"65"},{"groupId":"BG003","value":"66"},{"groupId":"BG004","value":"264"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"22"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"94"},{"groupId":"BG001","value":"95"},{"groupId":"BG002","value":"93"},{"groupId":"BG003","value":"98"},{"groupId":"BG004","value":"380"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"17"},{"groupId":"BG004","value":"73"}]}]}]},{"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":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"2"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"22"},{"groupId":"BG004","value":"85"}]},{"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":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"6"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"95"},{"groupId":"BG001","value":"94"},{"groupId":"BG002","value":"94"},{"groupId":"BG003","value":"97"},{"groupId":"BG004","value":"380"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"2"}]},{"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":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"Czechia","categories":[{"measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"23"},{"groupId":"BG003","value":"23"},{"groupId":"BG004","value":"94"}]}]},{"title":"Germany","categories":[{"measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"33"},{"groupId":"BG003","value":"32"},{"groupId":"BG004","value":"129"}]}]},{"title":"Japan","categories":[{"measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"20"},{"groupId":"BG003","value":"22"},{"groupId":"BG004","value":"82"}]}]},{"title":"Poland","categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"36"}]}]},{"title":"Puerto Rico","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"12"}]}]},{"title":"Slovakia","categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"31"}]}]},{"title":"Spain","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"14"},{"groupId":"BG004","value":"57"}]}]},{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"34"}]}]}]},{"title":"Hemoglobin A1c","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.30","spread":"0.88"},{"groupId":"BG001","value":"8.36","spread":"0.83"},{"groupId":"BG002","value":"8.23","spread":"0.86"},{"groupId":"BG003","value":"8.37","spread":"0.84"},{"groupId":"BG004","value":"8.31","spread":"0.85"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)","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 + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants from who received at least 1 dose 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.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Percentage of HbA1c","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG001","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"Placebo","description":"Placebo administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.59","spread":"0.081"},{"groupId":"OG001","value":"-2.59","spread":"0.083"},{"groupId":"OG002","value":"-0.93","spread":"0.079"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.66","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.88","ciUpperLimit":"-1.43"},{"groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.65","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.88","ciUpperLimit":"-1.43"}]},{"type":"SECONDARY","title":"Change From Baseline in HbA1c (5 mg)","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 + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomized participants who received at least one dose of 5 mg tirzepatide, placebo 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.","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":"5 mg tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"Placebo","description":"Placebo administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.23","spread":"0.081"},{"groupId":"OG001","value":"-0.93","spread":"0.079"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-1.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.52","ciUpperLimit":"-1.07"}]},{"type":"SECONDARY","title":"Change From Baseline in Body Weight","description":"Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Baseline HbA1c Group (\\<= 8.0%, \\>8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\\*Time (Type III sum of squares).","populationDescription":"All randomly assigned participants who took 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.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Kilograms (kg)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Placebo","description":"Placebo administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"113"},{"groupId":"OG002","value":"117"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.2","spread":"0.58"},{"groupId":"OG001","value":"-8.2","spread":"0.58"},{"groupId":"OG002","value":"-10.9","spread":"0.59"},{"groupId":"OG003","value":"1.7","spread":"0.57"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-7.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-9.4","ciUpperLimit":"-6.3"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-9.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.5","ciUpperLimit":"-8.3"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-12.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-14.2","ciUpperLimit":"-11.0"}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving an HbA1c Target Value of <7%","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.","populationDescription":"All randomly assigned participants who took 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.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Placebo","description":"Placebo administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"113"},{"groupId":"OG002","value":"117"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"93.04"},{"groupId":"OG001","value":"97.35"},{"groupId":"OG002","value":"94.02"},{"groupId":"OG003","value":"33.90"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"37.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"15.23","ciUpperLimit":"93.70"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"100.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"30.02","ciUpperLimit":"333.62"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"43.31","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"16.92","ciUpperLimit":"110.83"}]},{"type":"SECONDARY","title":"Change From Baseline in Fasting Serum Glucose","description":"Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS Mean was determined by MMRM model with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\\<= 8.0%, \\>8.0%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.","populationDescription":"All randomly assigned participants who took 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.","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":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Placebo","description":"Placebo administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"116"},{"groupId":"OG002","value":"118"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-61.4","spread":"2.55"},{"groupId":"OG001","value":"-67.9","spread":"2.55"},{"groupId":"OG002","value":"-67.7","spread":"2.64"},{"groupId":"OG003","value":"-38.9","spread":"2.49"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-22.5","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-29.5","ciUpperLimit":"-15.4"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-29.0","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-36.0","ciUpperLimit":"-22.0"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"-28.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-35.9","ciUpperLimit":"-21.6"}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values","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 + Baseline HbA1c Group (\\<= 8.0%, \\>8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment (Type III sum of squares).","populationDescription":"All randomly assigned participants who took 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.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Placebo","description":"Placebo administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"99"},{"groupId":"OG002","value":"94"},{"groupId":"OG003","value":"97"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-67.1","spread":"2.05"},{"groupId":"OG001","value":"-71.7","spread":"2.04"},{"groupId":"OG002","value":"-73.7","spread":"2.10"},{"groupId":"OG003","value":"-39.4","spread":"2.07"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieved Weight Loss ≥5%","description":"Percentage of Participants who Achieved Weight Loss ≥5%.","populationDescription":"All randomly assigned participants who took 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.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Placebo","description":"Placebo administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"113"},{"groupId":"OG002","value":"117"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"53.91"},{"groupId":"OG001","value":"64.60"},{"groupId":"OG002","value":"84.62"},{"groupId":"OG003","value":"5.93"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"17.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"7.55","ciUpperLimit":"38.93"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"27.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"11.87","ciUpperLimit":"62.55"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"79.61","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"32.76","ciUpperLimit":"193.44"}]},{"type":"SECONDARY","title":"Percentage Change From Baseline in Daily Mean Insulin Glargine Dose","description":"LS mean was calculated using MMRM model with log (Baseline) + Baseline Metformin Use (Yes, No) + Pooled Country + Baseline HbA1c Group (\\<= 8.0%, \\>8.0%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.","populationDescription":"All randomly assigned participants who took 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.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"International Units (IU)","timeFrame":"Baseline, Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Placebo","description":"Placebo administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"105"},{"groupId":"OG001","value":"103"},{"groupId":"OG002","value":"96"},{"groupId":"OG003","value":"111"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13.0","spread":"7.34"},{"groupId":"OG001","value":"8.1","spread":"7.03"},{"groupId":"OG002","value":"-11.4","spread":"5.85"},{"groupId":"OG003","value":"75.0","spread":"11.11"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Estimate Difference","paramValue":"-35.4","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-46.0","ciUpperLimit":"-22.8"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","paramType":"Estimate Difference","paramValue":"-38.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-48.3","ciUpperLimit":"-26.1"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","paramType":"Estimate Difference","paramValue":"-49.3","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-57.7","ciUpperLimit":"-39.4"}]},{"type":"SECONDARY","title":"Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia","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 Metformin Use (Yes, No) + Baseline HbA1c Group (\\<= 8.0%, \\>8.0%) + Treatment, with log (exposure in days/365.25) as an offset variable.","populationDescription":"All randomly assigned participants who took at least 1 dose of study drug.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Episodes/participant/365.25 days","timeFrame":"Baseline through Safety Follow-Up (Up to Week 44)","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Placebo","description":"Placebo administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"116"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"120"},{"groupId":"OG003","value":"120"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.49","spread":"0.141"},{"groupId":"OG001","value":"0.66","spread":"0.169"},{"groupId":"OG002","value":"0.38","spread":"0.099"},{"groupId":"OG003","value":"0.51","spread":"0.149"}]}]}]},{"type":"SECONDARY","title":"Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide","description":"AUC is a combined measure obtained from Week 7, 15, 23 and 39 and a single averaged measure of AUC was reported.","populationDescription":"All randomized participants who received at least one dose and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram*hour per milliliter (ng*h/mL)","timeFrame":"Week 7, 15, 23 and 39 post dose","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"116"},{"groupId":"OG002","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"79700","spread":"24.5"},{"groupId":"OG001","value":"164000","spread":"26.7"},{"groupId":"OG002","value":"246000","spread":"26.4"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving an HbA1c Target Value of <5.7%","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.","populationDescription":"All randomly assigned participants who took 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","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"Week 40","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week."},{"id":"OG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week."},{"id":"OG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week."},{"id":"OG003","title":"Placebo","description":"Placebo administered SC once a week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"113"},{"groupId":"OG002","value":"117"},{"groupId":"OG003","value":"118"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26.09"},{"groupId":"OG001","value":"47.79"},{"groupId":"OG002","value":"62.39"},{"groupId":"OG003","value":"2.54"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"12.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.93","ciUpperLimit":"38.00"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"32.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"10.52","ciUpperLimit":"99.49"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"56.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"18.27","ciUpperLimit":"173.26"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Baseline, 17 Months","description":"All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.","eventGroups":[{"id":"EG000","title":"5 mg Tirzepatide","description":"5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.","deathsNumAffected":0,"deathsNumAtRisk":116,"seriousNumAffected":9,"seriousNumAtRisk":116,"otherNumAffected":52,"otherNumAtRisk":116},{"id":"EG001","title":"10 mg Tirzepatide","description":"10 mg tirzepatide administered SC once a week.","deathsNumAffected":0,"deathsNumAtRisk":119,"seriousNumAffected":13,"seriousNumAtRisk":119,"otherNumAffected":60,"otherNumAtRisk":119},{"id":"EG002","title":"15 mg Tirzepatide","description":"15 mg tirzepatide administered SC once a week.","deathsNumAffected":0,"deathsNumAtRisk":120,"seriousNumAffected":9,"seriousNumAtRisk":120,"otherNumAffected":67,"otherNumAtRisk":120},{"id":"EG003","title":"Placebo","description":"Placebo administered SC once a week.","deathsNumAffected":0,"deathsNumAtRisk":120,"seriousNumAffected":10,"seriousNumAtRisk":120,"otherNumAffected":58,"otherNumAtRisk":120}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Angina pectoris","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Cardiac failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Deafness unilateral","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Abdominal hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Faecaloma","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Pancreatic disorder","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Asthenia","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Impaired healing","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Cellulitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Coronavirus infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Covid-19 pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Gastroenteritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Postoperative wound infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Pyelonephritis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Urinary tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Hip fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Humerus fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Intestinal anastomosis complication","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Spinal compression fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Hypoglycaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Spinal stenosis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Synovial cyst","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Papillary renal cell carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Renal neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Transitional cell carcinoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Uterine cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":55},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":55},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":54}]},{"term":"Hypoglycaemic unconsciousness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Orthostatic intolerance","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Syncope","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Transient ischaemic attack","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Bladder disorder","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Calculus urinary","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":2,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Chronic obstructive pulmonary disease","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Dyspnoea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Pulmonary embolism","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Respiratory failure","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Sleep apnoea syndrome","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Cardiac ablation","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Pancreatic lesion excision","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Aortic stenosis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":120},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Peripheral arterial occlusive disease","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":116},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":119},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]}],"otherEvents":[{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":116},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":119},{"groupId":"EG002","numEvents":9,"numAffected":8,"numAtRisk":120},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":120}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":22,"numAffected":14,"numAtRisk":116},{"groupId":"EG001","numEvents":46,"numAffected":15,"numAtRisk":119},{"groupId":"EG002","numEvents":44,"numAffected":25,"numAtRisk":120},{"groupId":"EG003","numEvents":12,"numAffected":12,"numAtRisk":120}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":9,"numAffected":8,"numAtRisk":116},{"groupId":"EG001","numEvents":12,"numAffected":10,"numAtRisk":119},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":120},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":120}]},{"term":"Eructation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":6,"numAtRisk":116},{"groupId":"EG001","numEvents":16,"numAffected":4,"numAtRisk":119},{"groupId":"EG002","numEvents":11,"numAffected":7,"numAtRisk":120},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":120}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":116},{"groupId":"EG001","numEvents":21,"numAffected":6,"numAtRisk":119},{"groupId":"EG002","numEvents":12,"numAffected":7,"numAtRisk":120},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":120}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":26,"numAffected":15,"numAtRisk":116},{"groupId":"EG001","numEvents":43,"numAffected":21,"numAtRisk":119},{"groupId":"EG002","numEvents":44,"numAffected":22,"numAtRisk":120},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":120}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":12,"numAffected":8,"numAtRisk":116},{"groupId":"EG001","numEvents":18,"numAffected":9,"numAtRisk":119},{"groupId":"EG002","numEvents":26,"numAffected":15,"numAtRisk":120},{"groupId":"EG003","numEvents":3,"numAffected":3,"numAtRisk":120}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":23,"numAffected":18,"numAtRisk":116},{"groupId":"EG001","numEvents":11,"numAffected":8,"numAtRisk":119},{"groupId":"EG002","numEvents":19,"numAffected":15,"numAtRisk":120},{"groupId":"EG003","numEvents":27,"numAffected":23,"numAtRisk":120}]},{"term":"Lipase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":116},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":119},{"groupId":"EG002","numEvents":12,"numAffected":10,"numAtRisk":120},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":120}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":8,"numAtRisk":116},{"groupId":"EG001","numEvents":17,"numAffected":15,"numAtRisk":119},{"groupId":"EG002","numEvents":21,"numAffected":17,"numAtRisk":120},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":120}]},{"term":"Hyperglycaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":116},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":119},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":18,"numAffected":16,"numAtRisk":120}]},{"term":"Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":6,"numAtRisk":116},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":119},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":120},{"groupId":"EG003","numEvents":2,"numAffected":2,"numAtRisk":120}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":6,"numAtRisk":116},{"groupId":"EG001","numEvents":7,"numAffected":6,"numAtRisk":119},{"groupId":"EG002","numEvents":6,"numAffected":4,"numAtRisk":120},{"groupId":"EG003","numEvents":7,"numAffected":7,"numAtRisk":120}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":116},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":119},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":120},{"groupId":"EG003","numEvents":7,"numAffected":7,"numAtRisk":120}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"800-545-5979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2020-06-26","uploadDate":"2021-07-07T02:23","filename":"Prot_000.pdf","size":8822303},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2021-02-01","uploadDate":"2021-07-07T02:18","filename":"SAP_001.pdf","size":7047505}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D000098860","term":"Tirzepatide"}],"ancestors":[{"id":"D000067757","term":"Glucagon-Like Peptide-1 Receptor"},{"id":"D000067756","term":"Glucagon-Like Peptide Receptors"},{"id":"D043562","term":"Receptors, G-Protein-Coupled"},{"id":"D011956","term":"Receptors, Cell Surface"},{"id":"D008565","term":"Membrane Proteins"},{"id":"D011506","term":"Proteins"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D011964","term":"Receptors, Gastrointestinal Hormone"},{"id":"D018000","term":"Receptors, Peptide"}]}},"hasResults":true}