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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
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.
Details
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 28 |
| Start date | 2026-02-24 |
| Completion | 2026-10 |
Conditions
- Kidney Disease
- Renal Insufficiency Chronic
- Kidney Failure, Chronic
- Renal Impairment
- Renal Insufficiency
- End Stage Kidney Disease
Interventions
- LY3841136
Primary outcomes
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3841136 — Predose on Day 1 up to Day 71
- PK: Maximum Observed Drug Concentration (Cmax) of LY3841136 — Predose on Day 1 up to Day 71
Countries
United States