{"protocolSection":{"identificationModule":{"nctId":"NCT05936138","orgStudyIdInfo":{"id":"18633"},"secondaryIdInfos":[{"id":"J2A-MC-GZPC","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment.","officialTitle":"A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment"},"statusModule":{"statusVerifiedDate":"2026-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-07-13","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-04-11","type":"ACTUAL"},"completionDateStruct":{"date":"2024-04-11","type":"ACTUAL"},"studyFirstSubmitDate":"2023-06-30","studyFirstSubmitQcDate":"2023-06-30","studyFirstPostDateStruct":{"date":"2023-07-07","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-30","resultsFirstSubmitQcDate":"2026-06-08","resultsFirstPostDateStruct":{"date":"2026-06-09","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-06-08","lastUpdatePostDateStruct":{"date":"2026-06-09","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 assess the amount of study drug (LY3502970) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3502970 will also be evaluated in these participants. The study will last up to 6 weeks including screening period."},"conditionsModule":{"conditions":["Renal Insufficiency","Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":24,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"LY3502970 (Normal Renal Function)","type":"EXPERIMENTAL","description":"A single oral dose of 1 milligram (mg) LY3502970 was administered to participants with normal renal function \\[defined as an estimated glomerular filtration rate (eGFR: ≥ 90 milliliters per minute (mL/min), and without a diagnosis of type 2 diabetes mellitus (T2D)\\] on day 1.","interventionNames":["Drug: LY3502970"]},{"label":"LY3502970 (Severe Renal Impairment)","type":"EXPERIMENTAL","description":"A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function \\[defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D\\] on day 1.","interventionNames":["Drug: LY3502970"]},{"label":"LY3502970 (End-Stage Renal Disease)","type":"EXPERIMENTAL","description":"A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease \\[defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D\\] on day 1.","interventionNames":["Drug: LY3502970"]}],"interventions":[{"type":"DRUG","name":"LY3502970","description":"Administered orally.","armGroupLabels":["LY3502970 (End-Stage Renal Disease)","LY3502970 (Normal Renal Function)","LY3502970 (Severe Renal Impairment)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY3502970","description":"PK: (AUC0-∞) of LY3502970 is reported.","timeFrame":"Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose"},{"measure":"PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970","description":"PK: AUC0-tlast of LY3502970 is reported.","timeFrame":"Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose"},{"measure":"PK: Maximum Observed Concentration (Cmax) of LY3502970","description":"PK: Cmax of LY3502970 is reported.","timeFrame":"Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have a body mass index within the range 18.5 to 42.0 kilograms per meter squared (kg/m²), inclusive.\n* Men and women who agree to use highly effective or effective methods of contraception may participate in this trial.\n\nParticipants with Normal Renal Function:\n\n* Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function. Have estimated glomerular filtration rate (eGFR) of greater than or equal to 90 milliliter per minute (mL/min)\n\nParticipants with Renal Impairment:\n\n* Severe renal impairment: Have eGFR of 15 to 29 mL/min and not requiring hemodialysis.\n* ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing.\n\nExclusion Criteria:\n\n* Have a current, functioning organ transplant. Non-functional renal allografts may be allowed.\n* Regularly use known drugs of abuse or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications.\n* Have known allergies to LY3502970, related compounds, or any components of the formulation, or history of severe atopy.\n* Are lactating, pregnant, or intend to become pregnant, or to breastfeed during the study.\n* Have a history or presence of chronic or acute pancreatitis\n\nParticipants with Renal Impairment:\n\n* Have hemoglobin \\<8.5 g/dL.\n* Participants with Type 2 Diabetes Mellitus if they have taken any Glucagon-like Peptide-1 Receptor Agonists (GLP1-RA) or a Dipeptidyl Peptidase 4 (DPP4) inhibitor in the past 6 weeks or 5 half-lives prior to dosing, whichever is longer, prior to dosing on Day 1","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"85 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":"Clinical Pharmacology of Miami","city":"Miami","state":"Florida","zip":"33014","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Advanced Pharma CR, LLC","city":"Miami","state":"Florida","zip":"33147","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Orlando Clinical Research Center","city":"Orlando","state":"Florida","zip":"32809","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Alliance For multispecialty Research, LLC","city":"Knoxville","state":"Tennessee","zip":"37920","country":"United States","geoPoint":{"lat":35.96064,"lon":-83.92074}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"LY3502970 (Normal Renal Function)","description":"A single oral dose of 1 milligram (mg) LY3502970 was administered to participants with normal renal function \\[defined as an estimated glomerular filtration rate (eGFR: ≥ 90 milliliters per minute (mL/min), and without a diagnosis of type 2 diabetes mellitus (T2D)\\] on day 1."},{"id":"FG001","title":"LY3502970 (Severe Renal Impairment)","description":"A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function \\[defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D\\] on day 1."},{"id":"FG002","title":"LY3502970 (End-Stage Renal Disease)","description":"A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease \\[defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D\\] on day 1."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"8"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"7"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Inadvertent Enrollment","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All enrolled 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groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"24"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.6","spread":"6.54"},{"groupId":"BG001","value":"61.7","spread":"17.07"},{"groupId":"BG002","value":"53.8","spread":"10.42"},{"groupId":"BG003","value":"57.8","spread":"11.09"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"4"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"20"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"7"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"16"}]},{"title":"Unknown or Not 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American","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"8"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"15"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"United 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disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":6},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":8}]},{"term":"Haemodialysis","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6},{"groupId":"EG002","numEvents":20,"numAffected":5,"numAtRisk":8}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and 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