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

March 12, 2026 updated by: Eli Lilly and Company

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami Lakes, Florida, United States, 33016-1518
        • Recruiting
        • Floridian Clinical Research, LLC
        • Principal Investigator:
          • Pedro Hernandez
        • Contact:
          • Phone Number: 305.330.9977 Notes:
      • Orlando, Florida, United States, 32808
        • Recruiting
        • Omega Research Orlando LLC
        • Principal Investigator:
          • Kwabena Ayesu
        • Contact:
          • Phone Number: 407-512-1054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eloralintide (Group 1)
Eloralintide administered subcutaneously (SC) in a control group of participants with normal renal function
Drug: LY3841136
Administered SC
Other Names:
  • Eloralintide
Experimental: Eloralintide (Groups 2 and 3)
Eloralintide administered SC in groups of participants with impaired renal function
Drug: LY3841136
Administered SC
Other Names:
  • Eloralintide
Experimental: Eloralintide (Group 3)
Eloralintide administered SC in a group of participants with end-stage renal disease (ESRD) on stable hemodialysis
Drug: LY3841136
Administered SC
Other Names:
  • Eloralintide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3841136
Time Frame: Predose on Day 1 up to Day 71
Predose on Day 1 up to Day 71
PK: Maximum Observed Drug Concentration (Cmax) of LY3841136
Time Frame: Predose on Day 1 up to Day 71
Predose on Day 1 up to Day 71

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27752
  • J3R-MC-YDAJ (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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