Actively Recruiting
A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Eloralintide in Participants With Severe Renal Impairment and End Stage Renal Disease Compared With Those With Normal Renal Function
Led by Eli Lilly and Company · Updated on 2026-03-13
28
Participants Needed
2
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating how much Eloralintide (LY3841136) reaches the bloodstream and how quickly it is cleared in people with kidney impairment compared to those with normal kidney function. This study focuses on participants with severe renal impairment, end-stage kidney disease on stable hemodialysis, and healthy individuals with normal renal function. The study aims to understand the pharmacokinetics and safety of the drug when given by injection under the skin. Participants receive a single dose of Eloralintide administered subcutaneously. The study includes three groups: one group with normal kidney function, one with impaired kidney function, and one with end-stage renal disease undergoing hemodialysis. The study design is open-label and non-randomized, lasting about 14 weeks for each participant, excluding the screening period. During the study, participants will undergo assessments to measure the drug concentration in their blood over time, including the area under the concentration curve and the maximum drug concentration. Researchers will monitor safety and collect medical history, physical exams, and other screening tests. The study is sponsored by Eli Lilly and Company and aims to provide detailed information about how Eloralintide behaves in the body of those with varying kidney functions.
CONDITIONS
Brief Title
A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight of 55 kilograms or more and body mass index between 19.0 and 40.0 kg/m²
- No significant history of spontaneous or ethanol-induced hypoglycemia
- Group 1: Healthy with normal kidney function (eGFR at least 90 mL/min)
- Group 1: Glycated hemoglobin (HbA1c) less than or equal to 6.5% at screening
- Groups 2 and 3: Stable severe renal impairment (eGFR less than 30 mL/min) or end-stage renal disease on stable hemodialysis for at least 3 months
- Groups 2 and 3: Acceptable blood pressure and pulse rate
- Groups 2 and 3: If type 2 diabetes is present, HbA1c less than or equal to 10.0% at screening
You will not qualify if you...
- History of chronic liver disease or hepatitis, including autoimmune hepatitis
- Current functioning organ transplant (nonfunctional renal allografts may be considered)
- Significant history or current disorders affecting drug absorption, metabolism, or elimination, or interfering with data interpretation
- Groups 2 and 3: Receiving continuous hemodialysis or peritoneal dialysis
- Groups 2 and 3: Use of drugs for renal impairment not established in dose and given for at least 7 days before study drug administration
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 71 days
Participants receive subcutaneous administration of Eloralintide according to their group assignment based on renal function.
Trial Site Locations
Total: 2 locations
1
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States, 33016-1518
Actively Recruiting
2
Omega Research Orlando LLC
Orlando, Florida, United States, 32808
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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