← Trials/Trial dossier/NCT07401862

RecruitingPhase 1

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

Asset

Eloralintide

Subcutaneous · Amylin analog

Listed sites

3

Recruiting sites

2

Enrollment

36

estimated

Study population

Healthy volunteers, Hepatic impairment

Key I/E criteria

BMI 19-40Healthy volunteers

Primary endpoints

AUC From Zero to Infinity AUC(0-∞) of LY3841136PK: Maximum Observed Drug Concentration (Cmax) of LY3841136

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07401862
Org study ID27751
Secondary ID2025-523847-36-00
Secondary IDJ3R-MC-YDAHEli Lilly and Company

Timeline

Milestones

Study start2026-02-10actual
Study first posted2026-02-11actual
Last update posted2026-03-20actual
Primary completion2027-03estimated (month precision)
Study completion2027-03estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age85 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

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

Time frame:Predose on Day 1 up to Day 71

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Observed Drug Concentration (Cmax) of LY3841136

Time frame:Predose on Day 1 up to Day 71

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.