NCT07426380Active, not recruitingPhase 1
A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function
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
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 17 Feb 2026
- Start date
- 24 Feb 2026
- Primary completion date
- Oct 2026
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Chronic kidney disease
- NCT number
- NCT07426380
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 28
- From 24 Feb 2026 to the primary completion date, Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, any evidence for hepatic impairments
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Floridian Clinical Research, LLC Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Omega Research Orlando, LLC Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.