{"protocolSection":{"identificationModule":{"nctId":"NCT05051579","orgStudyIdInfo":{"id":"18210"},"secondaryIdInfos":[{"id":"J2A-MC-GZGI","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"2021-002805-88","type":"EUDRACT_NUMBER"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities","officialTitle":"A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities"},"statusModule":{"statusVerifiedDate":"2023-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-09-29","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-08-25","type":"ACTUAL"},"completionDateStruct":{"date":"2022-11-22","type":"ACTUAL"},"studyFirstSubmitDate":"2021-09-17","studyFirstSubmitQcDate":"2021-09-17","studyFirstPostDateStruct":{"date":"2021-09-21","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-08-23","resultsFirstSubmitQcDate":"2023-08-23","resultsFirstPostDateStruct":{"date":"2023-09-13","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-08-23","lastUpdatePostDateStruct":{"date":"2023-09-13","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 the study was to assess the effect of LY3502970 in participants who have obesity or are overweight."},"conditionsModule":{"conditions":["Obesity","Overweight and Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":272,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"12 milligram (mg) LY3502970","type":"EXPERIMENTAL","description":"Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.","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 once daily until 36 weeks.","interventionNames":["Drug: LY3502970"]},{"label":"36 mg-1 LY3502970","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 once daily until 36 weeks.","interventionNames":["Drug: LY3502970"]},{"label":"36 mg-2 LY3502970","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 once daily until 36 weeks.","interventionNames":["Drug: LY3502970"]},{"label":"45 mg-1 LY3502970","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 once daily until 36 weeks.","interventionNames":["Drug: LY3502970"]},{"label":"45 mg-2 LY3502970","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 once daily until 36 weeks.","interventionNames":["Drug: LY3502970"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants received placebo administered orally once daily until 36 weeks.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"LY3502970","description":"Administered orally","armGroupLabels":["12 milligram (mg) LY3502970","24 mg LY3502970","36 mg-1 LY3502970","36 mg-2 LY3502970","45 mg-1 LY3502970","45 mg-2 LY3502970"]},{"type":"DRUG","name":"Placebo","description":"Administered orally","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percent Change From Baseline in Body Weight in LY3502970 and Placebo","description":"Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables. 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Variance-Covariance structure (Percent Change from Baseline) = Unstructured.","timeFrame":"Baseline, Week 26"},{"measure":"Change From Baseline in Body Weight in LY3502970 and Placebo","description":"LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.","timeFrame":"Baseline, Week 36"},{"measure":"Change From Baseline in Waist Circumference in LY3502970 and Placebo","description":"LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. 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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":"37351564","type":"DERIVED","citation":"Wharton S, Blevins T, Connery L, Rosenstock J, Raha S, Liu R, Ma X, Mather KJ, Haupt A, Robins D, Pratt E, Kazda C, Konig M; GZGI Investigators. Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. N Engl J Med. 2023 Sep 7;389(10):877-888. doi: 10.1056/NEJMoa2302392. Epub 2023 Jun 23."}],"seeAlsoLinks":[{"label":"A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities","url":"https://trials.lillytrialguide.com/en-US/trial/1R7BP1Yw5t6roV3ZWFGzYQ"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"https://vivli.org/"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"For maintenance doses of LY3502970: 12, 24, 36, and 45 milligram (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 5 and 16.","groups":[{"id":"FG000","title":"12 mg LY3502970","description":"Participants received maintenance dose 12 mg with dose escalation starting from 3 mg, 6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks."},{"id":"FG001","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 once daily until 36 weeks."},{"id":"FG002","title":"36 mg -1 LY3502970","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 once daily until 36 weeks."},{"id":"FG003","title":"36 mg -2 LY3502970","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 once daily until 36 weeks."},{"id":"FG004","title":"45 mg -1 LY3502970","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 once daily until 36 weeks."},{"id":"FG005","title":"45 mg -2 LY3502970","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 once daily until 36 weeks."},{"id":"FG006","title":"Placebo","description":"Participants received placebo administered orally once daily until 36 weeks."}],"periods":[{"title":"Overall 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