Hepatic InsufficiencyPhase 1NCT07401862

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

A Phase 1 study testing LY3841136 in people with Hepatic Insufficiency, run by Eli Lilly and Company at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Insufficiency
What is being tested?: LY3841136
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 3 sitesin 2 countries
Study dates: 10 Feb 2026to Mar 2027
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

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

Country

City, postcode or hospital

Sites recruiting now only

3 sites in 2 countries

United States2 sites, 2 recruiting

Orlando Clinical Research Center
Orlando, Florida, 32809
407-240-7876
Thomas Marbury
Recruiting
American Research Corporation
San Antonio, Texas, 78215
210-447-6228
Eric Lawitz
Recruiting

Other trials in United States

Hungary1 site, 1 recruiting

CRU Early Phase Unit
Kistarcsa, H-2143
+28 999 540
Geza Lakner
Recruiting

Other trials in Hungary

About this study

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

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
Being tested: LY3841136
Medical subject headings: Hepatic Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3841136Drug
Also called Eloralintide
Administered SC

Study groups in NCT07401862
Study group	Role	What they receive
Eloralintide (Normal Hepatic Function)	Experimental	Eloralintide administered subcutaneously (SC) Receives: Drug: LY3841136
Eloralintide (Mild Hepatic Impairment)	Experimental	Eloralintide administered SC Receives: Drug: LY3841136
Eloralintide (Moderate Hepatic Impairment)	Experimental	Eloralintide administered SC Receives: Drug: LY3841136
Eloralintide (Severe Hepatic Impairment)	Experimental	Eloralintide administered SC Receives: Drug: LY3841136

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3841136
Measured: Predose on Day 1 up to Day 71
PK: Maximum Observed Drug Concentration (Cmax) of LY3841136
Measured: Predose on Day 1 up to Day 71

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 2026Mar 2027

First posted11 Feb 2026
Study start10 Feb 2026
Primary completionMar 2027 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07401862
Sponsor's protocol ID: 27751
Other IDs: J3R-MC-YDAH, 2025-523847-36-00, 2025
Status last verified: Jun 2026
First submitted: 4 Feb 2026
Last updated: 4 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

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

1-317-615-4559

LillyTrials@Lilly.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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