{"protocolSection":{"identificationModule":{"nctId":"NCT04867785","orgStudyIdInfo":{"id":"17774"},"secondaryIdInfos":[{"id":"J1I-MC-GZBD","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of LY3437943 in Participants With Type 2 Diabetes","officialTitle":"A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes"},"statusModule":{"statusVerifiedDate":"2023-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-05-13","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-07-08","type":"ACTUAL"},"completionDateStruct":{"date":"2022-10-27","type":"ACTUAL"},"studyFirstSubmitDate":"2021-04-29","studyFirstSubmitQcDate":"2021-04-29","studyFirstPostDateStruct":{"date":"2021-04-30","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-06-08","resultsFirstSubmitQcDate":"2023-06-08","resultsFirstPostDateStruct":{"date":"2023-07-03","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-06-08","lastUpdatePostDateStruct":{"date":"2023-07-03","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 43 weeks."},"conditionsModule":{"conditions":["Type 2 Diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":281,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"0.5 milligrams (mg) LY3437943","type":"EXPERIMENTAL","description":"Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).","interventionNames":["Drug: LY3437943"]},{"label":"4 mg LY3437943 (2 mg)","type":"EXPERIMENTAL","description":"Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.","interventionNames":["Drug: LY3437943"]},{"label":"4 mg LY3437943 (4 mg)","type":"EXPERIMENTAL","description":"Participants received 4 mg LY3437943 administered as SC injection QW.","interventionNames":["Drug: LY3437943"]},{"label":"8 mg LY3437943 (2 mg)","type":"EXPERIMENTAL","description":"Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.","interventionNames":["Drug: LY3437943"]},{"label":"8 mg LY3437943 (4 mg)","type":"EXPERIMENTAL","description":"Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.","interventionNames":["Drug: LY3437943"]},{"label":"12 mg LY3437943 (2 mg)","type":"EXPERIMENTAL","description":"Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as a SC injection QW.","interventionNames":["Drug: LY3437943"]},{"label":"1.5 mg Dulaglutide","type":"ACTIVE_COMPARATOR","description":"Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.","interventionNames":["Drug: Dulaglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received placebo administered as SC injection QW.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"LY3437943","description":"Administered SC","armGroupLabels":["0.5 milligrams (mg) LY3437943","12 mg LY3437943 (2 mg)","4 mg LY3437943 (2 mg)","4 mg LY3437943 (4 mg)","8 mg LY3437943 (2 mg)","8 mg LY3437943 (4 mg)"]},{"type":"DRUG","name":"Dulaglutide","description":"Administered SC","armGroupLabels":["1.5 mg Dulaglutide"]},{"type":"DRUG","name":"Placebo","description":"Administered SC","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Hemoglobin A1c (HbA1c)","description":"Change in HbA1c (%) from baseline in LY3437943 relative to placebo. HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Treatment\\*Time + Strata\\*Time + Baseline\\*Time.","timeFrame":"Baseline, 24 Weeks"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c","description":"Change in HbA1c (%) from baseline in LY3437943 relative to dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\\*Time + Strata\\*Time + Baseline\\*Time.","timeFrame":"Baseline, 24 Weeks"},{"measure":"Change From Baseline in HbA1c","description":"Change in HbA1c (%) from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\\*Time + Baseline HbA1c Group (\\<=8.5%, \\>8.5%)\\*Time + Baseline Body Mass Index (BMI) Group (\\<30 kilograms/square meter (kg/m2), \\>=30 kg/m2)\\*Time + Baseline\\*Time.","timeFrame":"Baseline, 36 Weeks"},{"measure":"Percentage of Participants Reaching HbA1c <7.0%","description":"Percentage of participants reaching HbA1c \\<7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \\[\\<30 kg/m2, ≥30 kg/m2\\] as fixed effects, and baseline HbA1c value as a covariate.","timeFrame":"Week 24"},{"measure":"Percentage of Participant Reaching HbA1c <7.0%","description":"Percentage of participants reaching HbA1c \\<7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \\[\\<30 kg/m2, ≥30 kg/m2\\] as fixed effects, and baseline HbA1c value as a covariate.","timeFrame":"Week 36"},{"measure":"Change From Baseline in Fasting Blood Glucose (FBG)","description":"Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\\*Time + Strata\\*Time + Baseline\\*Time.","timeFrame":"Baseline, 24 Weeks"},{"measure":"Change From Baseline in Fasting Blood Glucose (FBG)","description":"Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\\*Time + Baseline HbA1c Group (\\<=8.5%, \\>8.5%)\\*Time + Baseline BMI Group (\\<30kg/m2, \\>=30kg/m2)\\*Time + Baseline\\*Time.","timeFrame":"Baseline, 36 Weeks"},{"measure":"Change From Baseline in Body Weight","description":"Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\\*Time + Strata\\*Time + Baseline\\*Time.","timeFrame":"Baseline, 24 Weeks"},{"measure":"Change From Baseline in Body Weight","description":"Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. 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Juan","zip":"909","country":"Puerto Rico","geoPoint":{"lat":18.46633,"lon":-66.10572}}]},"referencesModule":{"references":[{"pmid":"42608321","type":"DERIVED","citation":"Ruotolo G, Harris C, Lin Y, Wilson JM, Pirro V, Duffin KL, Thomas MK, Hartman ML, Neill CO, Coskun T, Milicevic Z, Haupt A, Sattar N, Nicholls SJ. Retatrutide-Associated Improvements in Cardiovascular Risk Biomarkers in Adults With Obesity With or Without Type 2 Diabetes. Diabetes Obes Metab. 2026 Aug 17. doi: 10.1111/dom.71200. Online ahead of print."},{"pmid":"40609566","type":"DERIVED","citation":"Coskun T, Wu Q, Schloot NC, Haupt A, Milicevic Z, Khouli C, Harris C. Effects of retatrutide on body composition in people with type 2 diabetes: a substudy of a phase 2, double-blind, parallel-group, placebo-controlled, randomised trial. Lancet Diabetes Endocrinol. 2025 Aug;13(8):674-684. doi: 10.1016/S2213-8587(25)00092-0. Epub 2025 Jun 30."},{"pmid":"37385280","type":"DERIVED","citation":"Rosenstock J, Frias J, Jastreboff AM, Du Y, Lou J, Gurbuz S, Thomas MK, Hartman ML, Haupt A, Milicevic Z, Coskun T. Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA. Lancet. 2023 Aug 12;402(10401):529-544. doi: 10.1016/S0140-6736(23)01053-X. Epub 2023 Jun 26."}],"seeAlsoLinks":[{"label":"A Study of LY3437943 in Participants With Type 2 Diabetes","url":"https://trials.lillytrialguide.com/en-US/trial/6tv02tRhvMamBP866x6OPm"}]},"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 or 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":{"preAssignmentDetails":"Four maintenance doses of LY3437943 were evaluated: 0.5 mg, 4 mg, 8 mg, and 12 mg. Dose escalation occurred in certain cohorts up to Week 12 during the 36-week treatment period. For maintenance doses equal to or greater than 4 mg, the initial dose will be 2 mg or 4 mg followed by additional escalation steps as appropriate.","groups":[{"id":"FG000","title":"Placebo","description":"Participants received placebo administered as subcutaneous (SC) injection once weekly (QW)."},{"id":"FG001","title":"1.5 Milligrams (mg) Dulaglutide","description":"Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW."},{"id":"FG002","title":"0.5 mg LY3437943","description":"Participants received 0.5 mg LY3437943 administered as SC injection QW."},{"id":"FG003","title":"4 mg LY3437943 (2 mg)","description":"Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW."},{"id":"FG004","title":"4 mg LY3437943 (4 mg)","description":"Participants received 4 mg LY3437943 administered as SC injection QW."},{"id":"FG005","title":"8 mg LY3437943 (2 mg)","description":"Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW."},{"id":"FG006","title":"8 mg LY3437943 (4 mg)","description":"Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW."},{"id":"FG007","title":"12 mg LY3437943 (2 mg)","description":"Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"46"},{"groupId":"FG002","numSubjects":"47"},{"groupId":"FG003","numSubjects":"23"},{"groupId":"FG004","numSubjects":"24"},{"groupId":"FG005","numSubjects":"26"},{"groupId":"FG006","numSubjects":"24"},{"groupId":"FG007","numSubjects":"46"}]},{"type":"Received at Least 1 Dose of Study 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COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"2"},{"groupId":"FG007","numSubjects":"11"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"2"}]},{"type":"Lost to 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Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"1"}]},{"type":"Inadvertent Enrollment","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"1"}]},{"type":"Eligibility Criteria Not 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