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NCT Number: NCT07426380

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

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Key information

Conditions

Kidney Disease Chronic Disease Disease Attributes End Stage Kidney Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Impairment Renal Insufficiency Renal Insufficiency Chronic Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Floridian Clinical Research, LLC, Miami Lakes, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3841136

Drug

Administered SC

Other names: Eloralintide

Primary outcomes

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
PK: Maximum Observed Drug Concentration (Cmax) of LY3841136

Time frame: Predose on Day 1 up to Day 71

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 23, 2026
Registry last updated: Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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