Eloralintide in people with and without liver damage
Official title: 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
Run by Eli Lilly and Company · NCT07401862 · Data updated 2026-11-12
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 | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 3 sites (Orlando, Florida and 2 other locations) |
| Status | Recruiting |
| Started | February 10, 2026 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07401862 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Orlando Clinical Research Center
Orlando, Florida, United States Recruiting -
American Research Corporation
San Antonio, Texas, United States Recruiting -
CRU Early Phase Unit
Kistarcsa, Hungary Recruiting
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.