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

Recruiting now · Phase 1

Conditions studied: Kidney Disease, Renal Insufficiency Chronic, Kidney Failure, Chronic, Renal Impairment, Renal Insufficiency, End Stage Kidney Disease

In brief

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.

Key facts

Study ID

NCT07426380

Run by

Eli Lilly and Company

People needed

28

Starts

2026-02-24

Expected to finish

2026-10-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Omega Research Orlando LLC — Orlando, Florida, United States (enrolling)
• Floridian Clinical Research, LLC — Miami Lakes, Florida, United States

Full record on ClinicalTrials.gov

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