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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatic Insufficiency
• Intervention / Treatment: Drug: LY3841136

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• Hungary
  • Kistarcsa, Hungary, H-2143
    • Recruiting
    • CRU Early Phase Unit
    • Principal Investigator: Geza Lakner
    • Contact: Phone Number: +28 999 540
• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Recruiting
      • Orlando Clinical Research Center
      • Principal Investigator: Thomas Marbury
      • Contact: Phone Number: 407-240-7876
  • Texas
    • San Antonio, Texas, United States, 78215
      • Recruiting
      • American Research Corporation
      • Principal Investigator: Eric Lawitz
      • Contact: Phone Number: 210-447-6228

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eloralintide (Normal Hepatic Function); Eloralintide administered subcutaneously (SC)	Drug: LY3841136; Administered SC; Other Names: Eloralintide
Experimental: Eloralintide (Mild Hepatic Impairment); Eloralintide administered SC	Drug: LY3841136; Administered SC; Other Names: Eloralintide
Experimental: Eloralintide (Moderate Hepatic Impairment); Eloralintide administered SC	Drug: LY3841136; Administered SC; Other Names: Eloralintide
Experimental: Eloralintide (Severe Hepatic Impairment); Eloralintide administered SC	Drug: LY3841136; Administered SC; Other Names: Eloralintide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hepatic Insufficiency
• Other Study ID Numbers: 27751 (Det Obelske Familiefond); J3R-MC-YDAH (Other Identifier: Eli Lilly and Company); 2025-523847-36-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No