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Recruiting NCT07401862

A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.

Phase I Interventional Hepatic Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY3841136.
Who it may be relevant to
Registry conditions: Hepatic Insufficiency. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Multicenter, Open-Label, Parallel-Design Study to Assess the Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Eloralintide (LY3841136) in Participants With Mild, Moderate, or Severe Hepatic Impairment and Participants With Normal Hepatic Function

Overview

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.

Interventions

  • Drug LY3841136
    Administered SC

Primary outcome measures

  • 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]
  • PK: Maximum Observed Drug Concentration (Cmax) of LY3841136 [Time frame: Predose on Day 1 up to Day 71]

Eligibility criteria

Inclusion criteria

  • 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

Group 1

  • Are healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening

Groups 2 through 4

  • Have hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment who are considered acceptable for participation in this study by the investigator. Participants must have a diagnosis of chronic hepatic impairment of greater than 6 months per physician diagnosis and standard-of-care practice, with no clinically significant changes in the opinion of the investigator within 15 days prior to screening

Participants with hepatic impairment may have stable baseline medical conditions for which neither the condition nor treatments received would negatively impact the health of the participant or study conduct

Exclusion criteria

  • Have a history or presence of chronic or acute pancreatitis or elevation in serum amylase or lipase greater than 1.5 × upper limit of normal (ULN)
  • Are pregnant or intend to become pregnant or to breastfeed during the study

Group 1

  • Have liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 1.5 × ULN or total bilirubin (TBL) greater than 1.5 × ULN at screening
  • Have a current infection with hepatitis B virus (HBV), that is,
  • if hepatitis B surface antigen (HBsAg) is positive, the participant is excluded, or
  • if HBsAg is negative and anti-Hepatitis B core antibody (HBc) is positive, further testing for HBV deoxyribonucleic acid (DNA) is required, and
  • if the screening HBV DNA is positive, the participant is excluded
  • Have a current infection with hepatitis C virus (HCV), that is,
  • if anti-HCV is positive, a test for circulating HCV ribonucleic acid (RNA) is required, and
  • if HCV RNA test is positive, the participant is excluded

Groups 2, 3, and 4

  • Have presence of active portal shunt or transjugular intrahepatic portosystemic shunt
  • Require paracentesis more often than 2 times per month or are expected to require paracentesis during the study
  • Have evidence of spontaneous bacterial peritonitis within 6 months of screening
  • Have had variceal bleeding within 3 months of screening. If the participant has undergone a successful banding procedure, they may participate in the study providing at least 1 month has passed after the banding procedure at the time of screening
  • Show presence of hepatocellular carcinoma
  • Have hepatic encephalopathy of Grade 2 or higher
  • Have TBL greater than 15 milligrams per deciliter (mg/dL)
  • Have ALT greater than or equal to 6 × ULN

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 2 centers
  • Orlando Clinical Research Center — Orlando
  • American Research Corporation — San Antonio
Hungary · 1 center
  • CRU Early Phase Unit — Kistarcsa

Identifiers

NCT: NCT07401862 · 27751 · J3R-MC-YDAH · 2025-523847-36-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗