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.
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
- Are there results?
- Not yet: the study is under way
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
Physicians interested in becoming principal investigators please contact contact
3 sites in 2 countries
United States2 sites, 2 recruiting
- 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
Hungary1 site, 1 recruiting
- Recruiting
CRU Early Phase Unit
Kistarcsa, H-2143
+28 999 540
Geza Lakner
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
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07401862
- Acronym / sponsor ID
- 27751
- Conditions
- Hepatic Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eloralintide (Normal Hepatic Function) | Experimental | Drug: LY3841136Eloralintide administered subcutaneously (SC) |
| Eloralintide (Mild Hepatic Impairment) | Experimental | Drug: LY3841136Eloralintide administered SC |
| Eloralintide (Moderate Hepatic Impairment) | Experimental | Drug: LY3841136Eloralintide administered SC |
| Eloralintide (Severe Hepatic Impairment) | Experimental | Drug: LY3841136Eloralintide administered SC |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3841136Also: EloralintideAdministered SC | Drug | Eloralintide (Mild Hepatic Impairment), Eloralintide (Moderate Hepatic Impairment), Eloralintide (Normal Hepatic Function), Eloralintide (Severe Hepatic Impairment) |
Primary outcome
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
PK: Maximum Observed Drug Concentration (Cmax) of LY3841136
Time frame: Predose on Day 1 up to Day 71
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy LiversLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3841136 in people with Hepatic Insufficiency, run by Eli Lilly and Company at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.