Phase 1 Study of Eloralintide Given Under the Skin to Adults With Severe Kidney Problems and Those With Normal Kidney Function

What this Trial Is About

Researchers are studying Eloralintide LY3841136 to understand how much of the drug reaches the bloodstream and how long the body takes to clear it in people with kidney problems compared to those with normal kidney function. The study focuses on participants with different levels of kidney impairment, including those with severe renal impairment and those with end-stage renal disease on stable hemodialysis. This is a Phase 1 trial to evaluate the pharmacokinetics and safety of a single dose of Eloralintide. Participants will receive one subcutaneous under the skin injection of Eloralintide. The study includes groups with normal kidney function, severe renal impairment, and end-stage renal disease on hemodialysis. The study drug is administered once, and participants with end-stage renal disease will be on a stable hemodialysis schedule for at least three months before dosing. The study is open-label and non-randomized with parallel groups. Each participants involvement lasts about 14 weeks, not including the initial screening period. During this time, researchers will collect blood samples to measure drug levels and how it is processed by the body. Safety and pharmacokinetics are monitored through these assessments. The primary outcomes include the total drug exposure over time and the highest drug concentration observed. Participants may undergo physical exams, medical history reviews, and laboratory tests as part of the study assessments.

A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function