[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625726":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":79,"collaborators":39,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":39,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":39,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":39,"overallStatus":47,"whyStopped":39,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Eli Lilly and Company","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Eloralintide (Group 1)","EXPERIMENTAL","Eloralintide administered subcutaneously (SC) in a control group of participants with normal renal function",[13],"Drug: LY3841136",{"label":15,"type":10,"description":16,"interventionNames":17},"Eloralintide (Groups 2 and 3)","Eloralintide administered SC in groups of participants with impaired renal function",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Eloralintide (Group 3)","Eloralintide administered SC in a group of participants with end-stage renal disease (ESRD) on stable hemodialysis",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","LY3841136","Administered SC",[9,19,15],[29],"Eloralintide",[31],{"name":32,"affiliation":5,"role":33},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC\u002FGMT - 5 hours, EST)","STUDY_DIRECTOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","CONTACT","1-317-615-4559",null,"LillyTrials@Lilly.com",{"name":42,"role":37,"phone":39,"phoneExt":39,"email":43},"Physicians interested in becoming principal investigators please contact","clinical_inquiry_hub@lilly.com",[45,65],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Floridian Clinical Research, LLC","RECRUITING","Miami Lakes","Florida","33016-1518","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-80.30866,25.90871,{"lat":57,"lon":56},[60,62],{"name":39,"role":37,"phone":61,"phoneExt":39,"email":39},"305.330.9977 Notes:",{"name":63,"role":64,"phone":39,"phoneExt":39,"email":39},"Pedro Hernandez","PRINCIPAL_INVESTIGATOR",{"facility":66,"status":47,"city":67,"state":49,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Omega Research Orlando LLC","Orlando","32808",{"type":54,"coordinates":70},[71,72],-81.37924,28.53834,{"lat":72,"lon":71},[75,77],{"name":39,"role":37,"phone":76,"phoneExt":39,"email":39},"407-512-1054",{"name":78,"role":64,"phone":39,"phoneExt":39,"email":39},"Kwabena Ayesu",{"type":80,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100625726","phase-1-a-study-of-eloralintide-ly3841136-in-participants-with-renal-impairment-and-in-participants-with-normal-renal-function-100625726",false,"NCT07426380","A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function","A Phase 1, Multicenter, Parallel-Design, Single Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Eloralintide in Participants With Severe Renal Impairment and End Stage Renal Disease (ESRD) Compared With Participants With Normal Renal Function","Inclusion Criteria:\n\n* Have a body weight of 55 kilograms (kg) or more and a body mass index (BMI) within the range of 19.0 to 40.0 kilograms per square meter (kg\u002Fm²), inclusive\n* Have no significant history of spontaneous or ethanol-induced hypoglycemia\n\nAdditional Inclusion Criteria for Group 1\n\n* Are healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (eGFR) of at least 90 milliliters per minute (mL\u002Fmin)\n* Have glycated hemoglobin (HbA1c) less than or equal to 6.5% at screening\n\nAdditional Inclusion Criteria for Groups 2 and 3\n\n* Have stable severe renal impairment, assessed by eGFR less than 30 mL\u002Fmin at screening or with end-stage renal disease (ESRD) who have been on a stable hemodialysis (HD) schedule for at least 3 months prior to planned dosing\n* Have acceptable blood pressure and pulse rate\n* If participants have Type 2 Diabetes Mellitus (T2DM), they must have a HbA1c equal to or less than 10.0% at screening\n\nExclusion Criteria:\n\n* Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, any evidence for hepatic impairments\n* Have a current, functioning organ transplant. Nonfunctional renal allografts may be considered\n* Have significant history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational product; or interfering with the interpretation of data\n\nGroups 2 and 3\n\n* Are receiving continuous HD or peritoneal dialysis.\n* Have used any drug indicated for medical care of the participant's renal impairment, which is not established in dose and administered for at least 7 days before eloralintide administration",true,"ALL","18 Years","85 Years",{"count":93,"type":94},28,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","The purpose of the study is to assess the amount of Eloralintide (LY3841136) 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 and to healthy participants. The study drug will be administered subcutaneously (SC) (under the skin).\n\nFor each participant, the study will last about 14 weeks, excluding screening.",[100,101,102,103,104,105],"Kidney Disease","Renal Insufficiency Chronic","Kidney Failure, Chronic","Renal Impairment","Renal Insufficiency","End Stage Kidney Disease","2026-03-12",{"date":108,"type":109},"2026-03-13","ACTUAL",{"date":111,"type":109},"2026-02-24",{"date":113,"type":94},"2026-10",{"name":5,"class":6},2]