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A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.
Plain-language guide to NCT07401862: phase 1 randomized trial of Eloralintide, 36 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07401862
- Phase
- phase 1
- Status
- recruiting participants
- Start
- 2026-02-10
- Completion (planned or actual)
- 2027-03
- Participants
- 36 (estimated)
- Design
- randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Hepatic Insufficiency
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Eloralintide.
The main purpose of this study is to evaluate how a medicine, LY3841136, works in participants with different levels of liver damage and in participants with healthy liver.
The researchers want to see how the medicine is absorbed and used by the body, and if it causes any side effects, in participants with mild, moderate, or severe liver damage, as well as in participants with normal liver function.
For each participant, the study will last about 14 weeks, which will include a stay at the clinical research unit for 5 nights.
It had four arms (groups): Eloralintide (Normal Hepatic Function) (experimental), Eloralintide (Mild Hepatic Impairment) (experimental), Eloralintide (Moderate Hepatic Impairment) (experimental) and Eloralintide (Severe Hepatic Impairment) (experimental).
Eloralintide administered subcutaneously (SC).
Eloralintide administered SC.
Eloralintide administered SC.
The registry classes the interventions as drug.
Who Took Part
36 planned participants were the target.
It was open to people of any sex aged from 18 years up to 85 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Have a body weight of 55 kilograms (kg) or more and body mass index between 19.0 and 40.0 kilograms per square meter (kg/m²), inclusive. Are healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening.
The full record lists 3 inclusion and 18 exclusion criteria; among the exclusions: are pregnant or intend to become pregnant or to breastfeed during the study; have a current infection with hepatitis b virus (hbv), that is,; if hepatitis b surface antigen (hbsag) is positive, the participant is excluded, or.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Eloralintide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Eloralintide study did not mask who received what.
It started in 2026-02-10 with completion listed for 2027-03.
It ran at 3 sites in United States (2) and Hungary (1).
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: PK: Maximum Observed Drug Concentration (Cmax) of LY3841136 (time frame: Predose on Day 1 up to Day 71).
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Eloralintide in 36 people.
Its size is small, so on its own it can only give an early look.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Eloralintide compound page, all human trials.
Our Notes on the Compound
Eloralintide: An investigational selective amylin-receptor agonist studied in once-weekly phase 2 obesity trials.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.