{"protocolSection":{"identificationModule":{"nctId":"NCT05048719","orgStudyIdInfo":{"id":"17787"},"secondaryIdInfos":[{"id":"J2A-MC-GZGE","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2021-002806-29","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus","officialTitle":"A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo and Once-Weekly Dulaglutide in Participants With Type 2 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2023-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-09-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-09-30","type":"ACTUAL"},"completionDateStruct":{"date":"2022-09-30","type":"ACTUAL"},"studyFirstSubmitDate":"2021-09-13","studyFirstSubmitQcDate":"2021-09-13","studyFirstPostDateStruct":{"date":"2021-09-17","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-09-28","resultsFirstSubmitQcDate":"2023-09-28","resultsFirstPostDateStruct":{"date":"2023-10-17","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-09-28","lastUpdatePostDateStruct":{"date":"2023-10-17","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 LY3502970 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 30 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":383,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"3 milligrams (mg) LY3502970","type":"EXPERIMENTAL","description":"Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).","interventionNames":["Drug: LY3502970"]},{"label":"12 mg LY3502970","type":"EXPERIMENTAL","description":"Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.","interventionNames":["Drug: LY3502970"]},{"label":"24 mg LY3502970","type":"EXPERIMENTAL","description":"Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.","interventionNames":["Drug: LY3502970"]},{"label":"36 mg LY3502970 - 1","type":"EXPERIMENTAL","description":"Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.","interventionNames":["Drug: LY3502970"]},{"label":"36 mg LY3502970 - 2","type":"EXPERIMENTAL","description":"Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.","interventionNames":["Drug: LY3502970"]},{"label":"45 mg LY3502970 - 1","type":"EXPERIMENTAL","description":"Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.","interventionNames":["Drug: LY3502970"]},{"label":"45 mg LY3502970 - 2","type":"EXPERIMENTAL","description":"Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.","interventionNames":["Drug: LY3502970"]},{"label":"1.5 mg Dulaglutide","type":"ACTIVE_COMPARATOR","description":"Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).","interventionNames":["Drug: Dulaglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received matching placebo.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"LY3502970","description":"Administered orally","armGroupLabels":["12 mg LY3502970","24 mg LY3502970","3 milligrams (mg) LY3502970","36 mg LY3502970 - 1","36 mg LY3502970 - 2","45 mg LY3502970 - 1","45 mg LY3502970 - 2"]},{"type":"DRUG","name":"Dulaglutide","description":"Administered subcutaneously","armGroupLabels":["1.5 mg Dulaglutide"]},{"type":"DRUG","name":"Placebo","description":"Administered orally","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Placebo","description":"Administered subcutaneously","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in HbA1c in LY3502970 as Compared to Placebo","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured 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 + Country + Baseline HbA1c Group (\\<=8.0%, \\>8.0%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 26"}],"secondaryOutcomes":[{"measure":"Change From Baseline in HbA1c in LY3502970 as Compared to Dulaglutide","description":"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured 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 + Country + Baseline HbA1c Group (\\<=8.0%, \\>8.0%) + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.","timeFrame":"Baseline, Week 26"},{"measure":"Percentage of Participants With HbA1c ≤ 6.5%","description":"Percentage of Participants with HbA1c ≤ 6.5%. Odds ratio was calculated using logistic regression model.","timeFrame":"Week 26"},{"measure":"Percentage of Participants With HbA1c <7.0%","description":"Percentage of Participants with HbA1c \\<7.0%. Odds ratio was calculated using logistic regression model.","timeFrame":"Week 26"},{"measure":"Change From Baseline in Fasting Serum Glucose","description":"Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. 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Treatment with orforglipron, an oral glucagon like peptide-1 receptor agonist, is associated with improvements of CV risk biomarkers in participants with type 2 diabetes or obesity without diabetes. Cardiovasc Diabetol. 2025 Jun 6;24(1):240. doi: 10.1186/s12933-025-02781-x."},{"pmid":"37369232","type":"DERIVED","citation":"Frias JP, Hsia S, Eyde S, Liu R, Ma X, Konig M, Kazda C, Mather KJ, Haupt A, Pratt E, Robins D. Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. Lancet. 2023 Aug 5;402(10400):472-483. doi: 10.1016/S0140-6736(23)01302-8. Epub 2023 Jun 24."}]},"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":{"preAssignmentDetails":"For maintenance doses of LY3502970: 3, 12, 24, 36, and 45 milligrams (mg), the initial dose will be 2 or 3 mg followed by additional escalation steps as appropriate. The dose escalation varied by dose group where the target maintenance dose was achieved between Weeks 4 and 12.","groups":[{"id":"FG000","title":"Placebo","description":"Participants received matching placebo."},{"id":"FG001","title":"3 mg LY3502970","description":"Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD)."},{"id":"FG002","title":"12 mg LY3502970","description":"Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD."},{"id":"FG003","title":"24 mg LY3502970","description":"Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD."},{"id":"FG004","title":"36 mg LY3502970 - 1","description":"Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD."},{"id":"FG005","title":"36 mg LY3502970 - 2","description":"Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD."},{"id":"FG006","title":"45 mg LY3502970 - 1","description":"Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD."},{"id":"FG007","title":"45 mg LY3502970 - 2","description":"Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD."},{"id":"FG008","title":"1.5 mg Dulaglutide","description":"Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW)."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"55"},{"groupId":"FG001","numSubjects":"51"},{"groupId":"FG002","numSubjects":"56"},{"groupId":"FG003","numSubjects":"47"},{"groupId":"FG004","numSubjects":"27"},{"groupId":"FG005","numSubjects":"34"},{"groupId":"FG006","numSubjects":"31"},{"groupId":"FG007","numSubjects":"32"},{"groupId":"FG008","numSubjects":"50"}]},{"type":"Received At Least One Dose of Study 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COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"4"},{"groupId":"FG006","numSubjects":"2"},{"groupId":"FG007","numSubjects":"3"},{"groupId":"FG008","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"0"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"},{"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":"0"},{"groupId":"FG008","numSubjects":"0"}]},{"type":"Adverse 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