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

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT07426380
Phase
PHASE1
Status
Recruiting
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Conditions

  • End Stage Kidney Disease
  • Kidney Disease
  • Kidney Failure, Chronic
  • Renal Impairment
  • Renal Insufficiency
  • Renal Insufficiency Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • LY3841136 — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
Feb 24, 2026
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Eloralintide (Group 1)
    Eloralintide administered subcutaneously (SC) in a control group of participants with normal renal function
  • Experimental: Eloralintide (Groups 2 and 3)
    Eloralintide administered SC in groups of participants with impaired renal function
  • Experimental: Eloralintide (Group 3)
    Eloralintide administered SC in a group of participants with end-stage renal disease (ESRD) on stable hemodialysis

Primary Outcome Measure

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 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (2)

FacilityCityStateZIPSite coordinators
Floridian Clinical Research, LLCMiami LakesFlorida33016-1518
305.330.9977 Notes:
Pedro Hernandez (PRINCIPAL_INVESTIGATOR)
Omega Research Orlando LLCOrlandoFlorida32808
407-512-1054
Kwabena Ayesu (PRINCIPAL_INVESTIGATOR)

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By research site
Floridian Clinical Research, LLC· Miami Lakes, FLOmega Research Orlando LLC· Orlando, FL

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