{"protocolSection":{"identificationModule":{"nctId":"NCT05882032","orgStudyIdInfo":{"id":"18624"},"secondaryIdInfos":[{"id":"J2A-MC-GZPB","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of LY3502970 in Participants With Impaired and Normal Liver Function","officialTitle":"A Phase 1, Multicenter, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment"},"statusModule":{"statusVerifiedDate":"2026-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-06-13","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-11-18","type":"ACTUAL"},"completionDateStruct":{"date":"2024-11-18","type":"ACTUAL"},"studyFirstSubmitDate":"2023-05-22","studyFirstSubmitQcDate":"2023-05-22","studyFirstPostDateStruct":{"date":"2023-05-31","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-30","resultsFirstSubmitQcDate":"2026-04-30","resultsFirstPostDateStruct":{"date":"2026-05-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-04-30","lastUpdatePostDateStruct":{"date":"2026-05-27","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 measure how much of LY3502970 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to participants with normal liver function. The safety and tolerability of LY3502970 will also be evaluated. The study may last up to 6 weeks for each participant including the screening period."},"conditionsModule":{"conditions":["Healthy","Hepatic Insufficiency"],"keywords":["LY3502970","Pharmacokinetics Hepatic Impairment","GLP-1 Receptor Non-peptide agonist (GLP-1 NPA)"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":29,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1 mg LY3502970 (Control: Normal Hepatic Function)","type":"EXPERIMENTAL","description":"Participants with normal hepatic function received a single 1 milligram (mg) dose of LY3502970 administered orally on Day 1.","interventionNames":["Drug: LY3502970"]},{"label":"1 mg LY3502970 (Mild Hepatic Impairment)","type":"EXPERIMENTAL","description":"Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.","interventionNames":["Drug: LY3502970"]},{"label":"1 mg LY3502970 (Moderate Hepatic Impairment)","type":"EXPERIMENTAL","description":"Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.","interventionNames":["Drug: LY3502970"]},{"label":"1 mg LY3502970 (Severe Hepatic Impairment)","type":"EXPERIMENTAL","description":"Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.","interventionNames":["Drug: LY3502970"]}],"interventions":[{"type":"DRUG","name":"LY3502970","description":"Administered orally.","armGroupLabels":["1 mg LY3502970 (Control: Normal Hepatic Function)","1 mg LY3502970 (Mild Hepatic Impairment)","1 mg LY3502970 (Moderate Hepatic Impairment)","1 mg LY3502970 (Severe Hepatic Impairment)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of LY3502970","description":"PK: AUC (0-∞) of LY3502970.","timeFrame":"Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1"},{"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.","timeFrame":"Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1"},{"measure":"PK: Maximum Observed Concentration (Cmax) of LY3502970","description":"PK: Cmax of LY3502970.","timeFrame":"Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Men or women with body weight of at least 45 kilograms and a body mass index of 18.5 to 40.0 kilograms per meter squared (kg/m²).\n* Both healthy individuals and individuals with hepatic impairment classified as Child-Pugh Score A, B, C that is mild, moderate, or severe impairment, respectively, liver disease can participate who are considered acceptable for participation in this study by the investigator.\n* Participants must have a diagnosis of chronic hepatic impairment for more than 6 months per physician diagnosis and standard of care practice, with no clinically significant changes within 15 days prior to study intervention administration.\n* Participants may have mild stable baseline medical conditions for which neither the condition nor treatments received would negatively impact the health of the participant or study conduct.\n* Have acceptable BP and pulse rate, as determined by the investigator at screening.\n* No significant history of spontaneous or ethanol induced hypoglycemia.\n* Participants with Mild to Severe Hepatic Impairment who have a hemoglobin level of at least 8.5 grams/deciliter.\n* Participants with both T2DM and Hepatic Impairment have T2DM controlled with diet or exercise alone or on stable doses of anti-diabetic medications metformin or sulfonylureas, for at least 8 weeks prior to screening.\n* Participants with both T2DM and Hepatic Impairment have a hemoglobin A1c greater than or equal to 5.0% and less than or equal to 11.0% at the screening visit.\n* Participants with both T2DM and Hepatic Impairment have clinical laboratory test results within normal range or deemed clinically insignificant by the investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable.\n\nExclusion Criteria:\n\n* Have significant history of, or current, cardiovascular, respiratory, hepatic (applies to Group 1 only), renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.\n* Have a history or presence of pancreatitis, elevation in serum amylase or lipase (greater than 1.5-fold ULN) or GI disorder or any GI disease, which impacts gastric emptying.\n* Have any abnormality in the 12-lead ECG at screening.\n* Have severe atopy or have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions.\n* Have a history of, or current psychiatric disorders.\n* Women who are pregnant, intend to become pregnant or are breastfeeding a child are not eligible to participate.\n* Have taken any glucose-lowering medications other than metformin, sulfonylureas, and insulin, in the past 6 weeks or 5 half-lives (whichever is longer) prior to planned dosing.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"80 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":"Orlando Clinical Research Center","city":"Orlando","state":"Florida","zip":"32809","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"Texas Liver Institute","city":"San Antonio","state":"Texas","zip":"78215","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"facility":"Pinnacle Clinical Research","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}}]},"referencesModule":{"seeAlsoLinks":[{"label":"A Study of LY3502970 in Participants With Impaired and Normal Liver Function","url":"https://trials.lilly.com/en-US/trial/407541"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"1 mg LY3502970 (Control: Normal Hepatic Function)","description":"Participants with normal hepatic function received a single 1 milligram (mg) dose of LY3502970 administered orally on Day 1."},{"id":"FG001","title":"1 mg LY3502970 (Mild Hepatic Impairment)","description":"Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1."},{"id":"FG002","title":"1 mg LY3502970 (Moderate Hepatic Impairment)","description":"Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1."},{"id":"FG003","title":"1 mg LY3502970 (Severe Hepatic Impairment)","description":"Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"6"}]},{"type":"Received At Least One Dose of LY3502970","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"6"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"6"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All enrolled participants.","groups":[{"id":"BG000","title":"1 mg LY3502970 (Control: Normal Hepatic Function)","description":"Participants with normal hepatic function received a single 1 mg dose of LY3502970 administered orally on Day 1."},{"id":"BG001","title":"1 mg LY3502970 (Mild Hepatic Impairment)","description":"Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1."},{"id":"BG002","title":"1 mg LY3502970 (Moderate Hepatic Impairment)","description":"Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1."},{"id":"BG003","title":"1 mg LY3502970 (Severe Hepatic Impairment)","description":"Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"29"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54.1","spread":"11.2"},{"groupId":"BG001","value":"58.8","spread":"14.6"},{"groupId":"BG002","value":"64.3","spread":"5.5"},{"groupId":"BG003","value":"47.5","spread":"6.8"},{"groupId":"BG004","value":"55.8","spread":"11.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"12"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"17"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"18"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"11"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"2"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"25"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"29"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of LY3502970","description":"PK: AUC (0-∞) of LY3502970.","populationDescription":"All enrolled participants who received at least one dose of LY3502970 and had evaluable PK data for this outcome measure. Participants were excluded from the analysis if a participant had an adverse event (AE) of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax).","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram *hour per milliliter (ng*h/mL)","timeFrame":"Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1","groups":[{"id":"OG000","title":"1 mg LY3502970 (Control: Normal Hepatic Function)","description":"Participants with normal hepatic function received a single 1 mg dose of LY3502970 administered orally on Day 1."},{"id":"OG001","title":"1 mg LY3502970 (Mild Hepatic Impairment)","description":"Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1."},{"id":"OG002","title":"1 mg LY3502970 (Moderate Hepatic Impairment)","description":"Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1."},{"id":"OG003","title":"1 mg LY3502970 (Severe Hepatic Impairment)","description":"Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"130","spread":"26.8"},{"groupId":"OG001","value":"132","spread":"60.2"},{"groupId":"OG002","value":"209","spread":"32.6"},{"groupId":"OG003","value":"611","spread":"84.6"}]}]}]},{"type":"PRIMARY","title":"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.","populationDescription":"All enrolled participants who received at least one dose of LY3502970 and had evaluable PK data for this outcome measure. 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26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":6},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":6}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":6},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":6},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":6}]},{"term":"Pruritus","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":6},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":6},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":6}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"800-545-5979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2024-03-28","uploadDate":"2026-04-16T21:50","filename":"Prot_000.pdf","size":1973675},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis 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