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

NCT07401862 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: 27751J3R-MC-YDAH2025-523847-36-00
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3841136

  Predose on Day 1 up to Day 71

• PK: Maximum Observed Drug Concentration (Cmax) of LY3841136

  Predose on Day 1 up to Day 71

Study Arms (4)

Eloralintide (Normal Hepatic Function)

EXPERIMENTAL

Eloralintide administered subcutaneously (SC)

Drug: LY3841136

Eloralintide (Mild Hepatic Impairment)

EXPERIMENTAL

Eloralintide administered SC

Drug: LY3841136

Eloralintide (Moderate Hepatic Impairment)

EXPERIMENTAL

Eloralintide administered SC

Drug: LY3841136

Eloralintide (Severe Hepatic Impairment)

EXPERIMENTAL

Eloralintide administered SC

Drug: LY3841136

Interventions

LY3841136 DRUG

Administered SC

Also known as: Eloralintide

Eloralintide (Mild Hepatic Impairment); Eloralintide (Moderate Hepatic Impairment); Eloralintide (Normal Hepatic Function); Eloralintide (Severe Hepatic Impairment)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

RECRUITING

American Research Corporation

San Antonio, Texas, 78215, United States

RECRUITING

CRU Early Phase Unit

Kistarcsa, H-2143, Hungary

NOT YET RECRUITING

Related Links

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

MeSH Terms

Conditions

Hepatic Insufficiency

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

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

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); US (2)