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Phase 1 eloralintide, hepatic impairment (NCT07401862)

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Trial record

Trial name
Phase I, hepatic impairment pharmacokinetic study
Registry identifier
NCT07401862
Phase
Phase I
Sponsor
Eli Lilly and Company
Population
Participants with mild, moderate or severe hepatic impairment and participants with normal hepatic function
Intervention
Eloralintide (LY3841136), single subcutaneous dose
Comparator
None (open-label; participants with normal hepatic function are the comparison group)
Enrollment
36
Study status
Recruiting (confirmed 2026-10-01 via ClinicalTrials.gov; primary completion and completion 2027-03)
Start date
2026-02-10
Completion date
2027-03
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 a single dose of eloralintide is absorbed and handled by the body in people with mild, moderate or severe liver impairment compared with people whose livers work normally. It also records side effects. Each participant is in the study about 14 weeks. Sites are in the United States and Hungary.

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 mild, moderate or severe hepatic impairment and to people with normal liver function. The primary endpoints are the total drug exposure (AUC) and the peak concentration. The record lists 36 participants, and each is in the study for about 14 weeks, including a five-night stay at the research unit.

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 impaired groups need chronic liver impairment for more than six months, classed as Child-Pugh A, B or C. People with hepatocellular carcinoma, grade 2 or higher hepatic encephalopathy or recent variceal bleeding are excluded. Sites are in Florida, Texas and Hungary.

What the registry does not say

No results are posted. The endpoints are drug-level measures, so the record says nothing about how eloralintide works in people with liver disease, only how the body handles it. Primary completion is registered for March 2027.

Source: ClinicalTrials.gov record NCT07401862, 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