RecruitingPhase 1NCT07401862

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

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

Sponsor

Eli Lilly and Company

Enrollment

36 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

Hepatic Insufficiency

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

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 Criteria20

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