Eloralintide (LY3841136) in people with normal or impaired kidney 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
PHASE1 · Eli Lilly and Company · NCT07426380
This test will measure how much eloralintide enters the bloodstream and how quickly the body clears it in people with severe kidney impairment and in people with normal kidney function.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company (industry) |
| Locations | 2 sites (Miami Lakes, Florida and 1 other locations) |
| Trial ID | NCT07426380 on ClinicalTrials.gov |
What this trial studies
This Phase 1 pharmacokinetic study gives a single subcutaneous dose of eloralintide (LY3841136) to groups of participants with normal renal function and to participants with severe renal impairment, including those on stable hemodialysis. Blood samples will be collected over time to measure drug exposure and clearance, and participants will be followed for about 14 weeks total (excluding screening). Key entry criteria include body weight ≥55 kg, BMI 19–40 kg/m², and specific eGFR thresholds defining the normal and severe-impairment groups. Safety monitoring will include vital signs, laboratory tests, and hypoglycemia surveillance.
Who should consider this trial
Good fit: Adults who weigh at least 55 kg with BMI 19–40 kg/m² and either normal kidney function (eGFR ≥90 mL/min) or stable severe renal impairment (eGFR <30 mL/min or on stable hemodialysis) are the intended participants.
Not a fit: People with unstable medical conditions, a significant history of spontaneous or alcohol-induced hypoglycemia, or who do not meet the weight/BMI or kidney-function criteria are unlikely to receive direct benefit from participation.
Why it matters
Potential benefit: If successful, the results could help determine safe dosing recommendations for eloralintide in people with reduced kidney function, reducing the risk of overdose or unexpected side effects.
How similar studies have performed: Pharmacokinetic studies in people with renal impairment are a routine and previously successful approach for informing dosing of many drugs, so the method is well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Miami Lakes, Florida and 1 other locations
- Floridian Clinical Research, LLC — Miami Lakes, Florida, United States (RECRUITING)
- Omega Research Orlando LLC — Orlando, Florida, United States (RECRUITING)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Disease, Renal Insufficiency Chronic, Kidney Failure, Chronic, Renal Impairment, Renal Insufficiency, End Stage Kidney Disease