Recruiting
Phase 1

LY3841136

Sponsor:

Eli Lilly and Company

Code:

NCT07401862

Conditions

Hepatic Insufficiency

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

LY3841136

Study Details

Brief 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.

Conditions

Hepatic Insufficiency

Study ID

NCT07401862

Start date

Feb 10, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Eloralintide (Normal Hepatic Function)

Eloralintide administered subcutaneously (SC)

experimental: Eloralintide (Mild Hepatic Impairment)

Eloralintide administered SC

experimental: Eloralintide (Moderate Hepatic Impairment)

Eloralintide administered SC

experimental: Eloralintide (Severe Hepatic Impairment)

Eloralintide administered SC

Interventions

LY3841136

Administered SC

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Orlando Clinical Research Center

Recruiting

Orlando, Florida, United States, 32809

Contacts

407-240-7876

Principal Investigator:

Thomas Marbury

American Research Corporation

Recruiting

San Antonio, Texas, United States, 78215

Contacts

210-447-6228

Principal Investigator:

Eric Lawitz

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-06-04.