ClinicalTrials.gg
RecruitingNCT07401862Updated Jun 4, 2026

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

A Phase 1 interventional study of LY3841136 in Hepatic Insufficiency, sponsored by Eli Lilly and Company. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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, 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.

02

Conditions studied

  • Hepatic Insufficiency

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03

In context

Hepatic Insufficiency

113 studies on the registry are indexed under Hepatic Insufficiency; 15 are open to participants now.

This study's planned enrollment of 36 is above the median of 29 across 100 interventional studies indexed under Hepatic Insufficiency.

Browse Hepatic Insufficiency studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have a body weight of 55 kilograms (kg) or more and 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 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 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

Exclusion Criteria:

  • Have a history or presence of chronic or acute pancreatitis or elevation in serum amylase or lipase greater than 1.5 × (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 (AST) or alanine transaminase (ALT) greater than 1.5 × ULN or total (TBL) greater than 1.5 × ULN at screening
  • Have a current infection with 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 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
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Eloralintide (Normal Hepatic Function)

    Eloralintide administered subcutaneously (SC)

    Drug: LY3841136

  • Experimental
    Eloralintide (Mild Hepatic Impairment)

    Eloralintide administered SC

    Drug: LY3841136

  • Experimental
    Eloralintide (Moderate Hepatic Impairment)

    Eloralintide administered SC

    Drug: LY3841136

  • Experimental
    Eloralintide (Severe Hepatic Impairment)

    Eloralintide administered SC

    Drug: LY3841136

Interventions

  • Administered SC

    Also known as: Eloralintide

06

What researchers measure

Primary outcomes

  1. 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

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY3841136

    Time frame: Predose on Day 1 up to Day 71

07

Study locations

3 of 3 sites recruiting
  • Orlando Clinical Research Center
    Orlando, Florida 32809, United States
    Recruiting
    • · Contact407-240-7876
    • Thomas Marbury · Principal investigator
  • American Research Corporation
    San Antonio, Texas 78215, United States
    Recruiting
    • · Contact210-447-6228
    • Eric Lawitz · Principal investigator
  • CRU Early Phase Unit
    Kistarcsa, H-2143, Hungary
    Recruiting
    • · Contact+28 999 540
    • Geza Lakner · Principal investigator
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Mar 2027, 13 months after the start.

Of 38 industry-sponsored phase 1 interventional studies under Hepatic Insufficiency, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's planned 13 months is above that.

Counting every sponsor, half of 41 studies reached it within 8 months; a quarter within 5 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2026
First posted
Feb 11, 2026
StartActual
Feb 10, 2026
Primary completionEst.
Mar 2027
CompletionEst.
Mar 2027
Last update
Jun 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07401862
Responsible party
Sponsor
First posted
Feb 11, 2026
Start date
Feb 10, 2026
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jun 4, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Eloralintide

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