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Phase 1 eloralintide, renal impairment (NCT07426380)

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Trial record

Trial name
Phase I, renal impairment pharmacokinetic study
Registry identifier
NCT07426380
Phase
Phase I
Sponsor
Eli Lilly and Company
Population
Participants with severe renal impairment or end-stage kidney disease on hemodialysis, and participants with normal renal function
Intervention
Eloralintide (LY3841136), single subcutaneous dose
Comparator
None (open-label; participants with normal renal function are the comparison group)
Enrollment
28
Study status
Active, not recruiting (confirmed 2026-10-01 via ClinicalTrials.gov; primary completion and completion 2026-10)
Start date
2026-02-24
Completion date
2026-10
Results availability
No results posted on ClinicalTrials.gov as of 2026-10-01

Primary endpoints

  • Primary: eloralintide pharmacokinetics, AUC(0-infinity) and Cmax, from day 1 to day 71 (ClinicalTrials.gov, confirmed 2026-10-01)

Primary registry record

A trial registration shows that a study exists. It does not show that the compound works, is safe, or has been approved, and recruitment says nothing about the eventual result.

This open-label Phase 1 study measures how much eloralintide reaches the bloodstream and how long the body takes to clear it after a single dose, in people with severe kidney impairment or end-stage kidney disease on stable hemodialysis, and in people with normal kidney function. Each participant is in the study about 14 weeks, excluding screening. It runs at 2 United States sites.

Read with care: it is a clinical-pharmacology study, not a weight-loss study. A registry record describes a study’s plan and status. It is not a result, and it does not show that the drug works or is safe.

Study context

What the study tests

This Phase 1 open-label study gives a single subcutaneous dose of eloralintide to people with severe renal impairment or end stage kidney disease and compares how the body handles it with people who have normal kidney function. The primary endpoints are the total drug exposure (AUC) and the peak concentration. The record lists 28 participants, and each is in the study for about 14 weeks.

Who can take part

Adults aged 18 to 85 need a body weight of at least 55 kg and a BMI from 19 to 40. The healthy group needs an eGFR of at least 90 mL/min. The impaired groups need an eGFR below 30 or stable hemodialysis for at least three months. People with chronic liver disease or a functioning organ transplant are excluded. Both sites are in Florida.

What the registry does not say

The study is no longer recruiting and no results are posted. Its endpoints are drug-level measures, so the record does not say whether kidney function changes how well the drug works, and it gives no dosing guidance for these patients. Primary completion is registered for October 2026.

Source: ClinicalTrials.gov record NCT07426380, read on 2026-10-15. Registered plans can change.

References

  1. US National Library of Medicine. ClinicalTrials.gov registry records for the eloralintide clinical program. ClinicalTrials.gov. P1