NCT07426380PHASE1RecruitingAccepts Healthy Volunteers
A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function
Eli Lilly and Company
Start Date
2/24/2026
Completion Date
10/1/2026
Summary
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). For each participant, the study will last about 14 weeks, excluding screening.
Eligibility Criteria
Age Range: 18 years to 85 years
Inclusion Criteria:
* 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/m²), inclusive
* Have no significant history of spontaneous or ethanol-induced hypoglycemia
Additional Inclusion Criteria for Group 1
* 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/min)
* Have glycated hemoglobin (HbA1c) less than or equal to 6.5% at screening
Additional Inclusion Criteria for Groups 2 and 3
* Have stable severe renal impairment, assessed by eGFR less than 30 mL/min 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
* Have acceptable blood pressure and pulse rate
* If participants have Type 2 Diabetes Mellitus (T2DM), they must have a HbA1c equal to or less than 10.0% at screening
Exclusion Criteria:
* Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, any evidence for hepatic impairments
* Have a current, functioning organ transplant. Nonfunctional renal allografts may be considered
* 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
Groups 2 and 3
* Are receiving continuous HD or peritoneal dialysis.
* 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
Interventions
DRUG
LY3841136
Conditions
Kidney DiseaseRenal Insufficiency ChronicKidney Failure, ChronicRenal ImpairmentRenal InsufficiencyEnd Stage Kidney Disease
Locations
Floridian Clinical Research, LLC
Miami Lakes, Florida 33016-1518
United States
Omega Research Orlando LLC
Orlando, Florida 32808
United States