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

NCT07426380 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27752J3R-MC-YDAJ
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Kidney Disease; Renal Insufficiency Chronic; Kidney Failure, Chronic; Renal Impairment; Renal Insufficiency; End Stage Kidney Disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Eloralintide (Group 1)

EXPERIMENTAL

Eloralintide administered subcutaneously (SC) in a control group of participants with normal renal function

Drug: LY3841136

Eloralintide (Groups 2 and 3)

EXPERIMENTAL

Eloralintide administered SC in groups of participants with impaired renal function

Drug: LY3841136

Eloralintide (Group 3)

EXPERIMENTAL

Eloralintide administered SC in a group of participants with end-stage renal disease (ESRD) on stable hemodialysis

Drug: LY3841136

Interventions

LY3841136 DRUG

Administered SC

Also known as: Eloralintide

Eloralintide (Group 1); Eloralintide (Group 3); Eloralintide (Groups 2 and 3)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Floridian Clinical Research, LLC

Miami Lakes, Florida, 33016-1518, United States

RECRUITING

Omega Research Orlando LLC

Orlando, Florida, 32808, United States

RECRUITING

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)