Eloralintide in people with and without liver damage

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

This Phase 1 study will test how the medicine eloralintide (LY3841136) is absorbed, processed, and tolerated in adults with healthy livers and in those with mild, moderate, or severe liver damage.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Eli Lilly and Company (industry)
• Locations: 3 sites (Orlando, Florida and 2 other locations)
• Trial ID: NCT07401862 on ClinicalTrials.gov

What this trial studies

This is a Phase 1 interventional pharmacokinetic and safety study that enrolls adults with clinically normal liver function and adults with chronic hepatic impairment classified by Child-Pugh A, B, or C. Participants will receive LY3841136 and investigators will measure drug absorption, distribution, metabolism, and excretion as well as monitor for adverse events. Each participant's involvement lasts about 14 weeks and includes a 5-night stay in a clinical research unit for intensive sampling and safety assessments. The protocol requires stable chronic liver disease for impaired groups and standard screening to confirm eligibility.

Who should consider this trial

Good fit: Adults weighing at least 55 kg with BMI 19.0–40.0 kg/m² who either have normal liver function or chronic hepatic impairment (Child-Pugh A, B, or C) stable for more than 6 months and approved by the investigator are the intended participants.

Not a fit: People with unstable or recently changing liver disease, acute liver failure, children, pregnant people, or those outside the weight/BMI limits are not eligible and would be unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could define safe dosing and monitoring guidance for people with varying degrees of liver impairment taking eloralintide.

How similar studies have performed: Hepatic impairment cohort studies using Child-Pugh classifications are a standard and successful method to determine how liver damage alters drug exposure, though eloralintide-specific results are new.

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

Where this trial is running

Orlando, Florida and 2 other locations

• Orlando Clinical Research Center — Orlando, Florida, United States (RECRUITING)
• American Research Corporation — San Antonio, Texas, United States (RECRUITING)
• CRU Early Phase Unit — Kistarcsa, Hungary (NOT_YET_RECRUITING)

Study contacts

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

Conditions: Hepatic Insufficiency