{"protocolSection":{"identificationModule":{"nctId":"NCT03131687","orgStudyIdInfo":{"id":"16335"},"secondaryIdInfos":[{"id":"I8F-MC-GPGB","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2016-004179-33","type":"EUDRACT_NUMBER"},{"id":"2016","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2016"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus","officialTitle":"A Phase 2 Study of Once-Weekly LY3298176 Compared With Placebo and Dulaglutide in Patients With Type 2 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2019-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-05-24","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-08-01","type":"ACTUAL"},"completionDateStruct":{"date":"2018-08-01","type":"ACTUAL"},"studyFirstSubmitDate":"2017-04-24","studyFirstSubmitQcDate":"2017-04-24","studyFirstPostDateStruct":{"date":"2017-04-27","type":"ACTUAL"},"resultsFirstSubmitDate":"2019-07-31","resultsFirstSubmitQcDate":"2019-07-31","resultsFirstPostDateStruct":{"date":"2019-08-20","type":"ACTUAL"},"dispFirstSubmitDate":"2019-03-09","dispFirstSubmitQcDate":"2019-03-09","dispFirstPostDateStruct":{"date":"2019-03-12","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-07-31","lastUpdatePostDateStruct":{"date":"2019-08-20","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the efficacy of the study drug tirzepatide in participants with type 2 diabetes mellitus."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":318,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.","interventionNames":["Drug: Placebo"]},{"label":"1 mg Tirzepatide","type":"EXPERIMENTAL","description":"1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.","interventionNames":["Drug: tirzepatide","Drug: Placebo"]},{"label":"5 mg Tirzepatide","type":"EXPERIMENTAL","description":"5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.","interventionNames":["Drug: tirzepatide","Drug: Placebo"]},{"label":"10 mg Tirzepatide","type":"EXPERIMENTAL","description":"10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.","interventionNames":["Drug: tirzepatide","Drug: Placebo"]},{"label":"15 mg Tirzepatide","type":"EXPERIMENTAL","description":"15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.","interventionNames":["Drug: tirzepatide","Drug: Placebo"]},{"label":"1.5 mg Dulaglutide","type":"ACTIVE_COMPARATOR","description":"1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.","interventionNames":["Drug: Dulaglutide","Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"tirzepatide","description":"Administered SC","armGroupLabels":["1 mg Tirzepatide","10 mg Tirzepatide","15 mg Tirzepatide","5 mg Tirzepatide"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"Dulaglutide","description":"Administered SC","armGroupLabels":["1.5 mg Dulaglutide"],"otherNames":["LY2189265"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["1 mg Tirzepatide","1.5 mg Dulaglutide","10 mg Tirzepatide","15 mg Tirzepatide","5 mg Tirzepatide","Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response","description":"HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline.\n\nThe Least Squares Mean is Posterior mean.","timeFrame":"Baseline, Week 26"}],"secondaryOutcomes":[{"measure":"Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response","description":"HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline.\n\nThe Least Squares Mean is Posterior mean.","timeFrame":"Baseline, Week 12"},{"measure":"Change From Baseline to Week 26 in HbA1c","description":"HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\\*Time.","timeFrame":"Baseline, Week 26"},{"measure":"Change From Baseline to Week 12 in HbA1c","description":"HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\\*Time.","timeFrame":"Baseline, Week 12"},{"measure":"Change From Baseline in Body Weight","description":"Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\\*Time.","timeFrame":"Baseline, Week 26"},{"measure":"Percentage of Participants With 5% or Greater Body Weight Loss From Baseline","description":"Percentage of participants with 5% or greater body weight loss from baseline last observation carried forward (LOCF) analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.","timeFrame":"Week 26"},{"measure":"Percentage of Participants With 10% or Greater Body Weight Loss From Baseline","description":"Percentage of participants with 10% or greater body weight loss from baseline LOCF analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.","timeFrame":"Week 26"},{"measure":"Percentage of Participants Reaching the HbA1c Target of ≤6.5%","description":"Percentage of participants with HbA1c ≤6.5% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.","timeFrame":"Week 26"},{"measure":"Percentage of Participants Reaching the HbA1c Target of <7.0%","description":"Percentage of participants with HbA1c \\<7.0% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.","timeFrame":"Week 26"},{"measure":"Change From Baseline in Fasting Blood Glucose","description":"Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\\*Time.","timeFrame":"Baseline, Week 26"},{"measure":"Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)","description":"LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag,Treatment, time, treatment\\*time.","timeFrame":"Baseline, Week 26"},{"measure":"Change From Baseline in Total Cholesterol","description":"LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\\*Time.","timeFrame":"Baseline, Week 26"},{"measure":"Change From Baseline in Triglycerides","description":"LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\\*Time.","timeFrame":"Baseline, Week 26"},{"measure":"Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)","description":"LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\\*Time.","timeFrame":"Baseline, Week 26"},{"measure":"Change From Baseline in Waist Circumference","description":"LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\\*Time.","timeFrame":"Baseline, Week 26"},{"measure":"Number of Participants With Anti-Drug Antibodies","description":"Number of Participants With Anti-Drug Antibodies.","timeFrame":"Baseline through Week 30"},{"measure":"Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide","description":"Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide","timeFrame":"Predose: Week 1,8,12 and 26; Postdose: Week 1,2,4 and 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification.\n* Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.\n* If on metformin, have been treated with stable doses of metformin for at least 3 months.\n* Have a body mass index (BMI) ≥23 and \\<50 kilograms per square meter.\n\nExclusion Criteria:\n\n* Have type 1 diabetes (T1D).\n* Have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past.\n* Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke).\n* Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \\>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.\n* Have had chronic or acute pancreatitis any time prior to study entry.\n* Have an estimated glomerular filtration rate (eGFR) \\<45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.\n* Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry.\n* Have any condition that is a contraindication for use of the GLP-1 RA class (per country-specific labels) at study entry or develop such condition between study entry and randomization.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 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":"Internal Medicine Center LLC","city":"Mobile","state":"Alabama","zip":"36608","country":"United States","geoPoint":{"lat":30.69436,"lon":-88.04305}},{"facility":"Anaheim Clinical Trails","city":"Anaheim","state":"California","zip":"92801","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"Valley 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physician.","city":"Katowice","zip":"40-772","country":"Poland","geoPoint":{"lat":50.2597,"lon":19.02173}},{"facility":"Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA","city":"Lodz","zip":"90-242","country":"Poland","geoPoint":{"lat":51.77058,"lon":19.47395}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.","city":"Szczecin","zip":"70-506","country":"Poland","geoPoint":{"lat":53.42894,"lon":14.55302}},{"facility":"Manati Center for Clinical Research","city":"Manati","state":"PR","zip":"00674","country":"Puerto Rico","geoPoint":{"lat":18.42745,"lon":-66.49212}},{"facility":"Clinical Research Puerto Rico. Inc","city":"San Juan","zip":"00909","country":"Puerto Rico","geoPoint":{"lat":18.46633,"lon":-66.10572}},{"facility":"GCM Medical Group PSC","city":"San Juan","zip":"00909","country":"Puerto Rico","geoPoint":{"lat":18.46633,"lon":-66.10572}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Košice","zip":"04012","country":"Slovakia","geoPoint":{"lat":48.71441,"lon":21.25802}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Malacky","zip":"90101","country":"Slovakia","geoPoint":{"lat":48.43604,"lon":17.02188}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Púchov","zip":"02001","country":"Slovakia","geoPoint":{"lat":49.12494,"lon":18.32597}},{"facility":"\"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.\"","city":"Trenčín","zip":"91101","country":"Slovakia","geoPoint":{"lat":48.89452,"lon":18.04436}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.","city":"Trenčín","zip":"91101","country":"Slovakia","geoPoint":{"lat":48.89452,"lon":18.04436}}]},"referencesModule":{"references":[{"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":"34608929","type":"DERIVED","citation":"Pirro V, Roth KD, Lin Y, Willency JA, Milligan PL, Wilson JM, Ruotolo G, Haupt A, Newgard CB, Duffin KL. Effects of Tirzepatide, a Dual GIP and GLP-1 RA, on Lipid and Metabolite Profiles in Subjects With Type 2 Diabetes. J Clin Endocrinol Metab. 2022 Jan 18;107(2):363-378. doi: 10.1210/clinem/dgab722."},{"pmid":"32291277","type":"DERIVED","citation":"Hartman ML, Sanyal AJ, Loomba R, Wilson JM, Nikooienejad A, Bray R, Karanikas CA, Duffin KL, Robins DA, Haupt A. Effects of Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide on Biomarkers of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes. Diabetes Care. 2020 Jun;43(6):1352-1355. doi: 10.2337/dc19-1892. Epub 2020 Apr 14."},{"pmid":"30293770","type":"DERIVED","citation":"Frias JP, Nauck MA, Van J, Kutner ME, Cui X, Benson C, Urva S, Gimeno RE, Milicevic Z, Robins D, Haupt A. Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised, placebo-controlled and active comparator-controlled phase 2 trial. Lancet. 2018 Nov 17;392(10160):2180-2193. doi: 10.1016/S0140-6736(18)32260-8. Epub 2018 Oct 4."}],"seeAlsoLinks":[{"label":"A Study of tirzepatide in Participants With Type 2 Diabetes Mellitus","url":"https://www.lillytrialguide.com/en-US/studies/diabetes/GPGB#?postal="}]},"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. 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