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
Eli Lilly and Company
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
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- Yes
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 scr…
Interventions
- DrugLY3841136
Administered SC
Locations (2)
- Floridian Clinical Research, LLCMiami Lakes, Florida
- Omega Research Orlando LLCOrlando, Florida