Actively Recruiting
A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.
Led by Eli Lilly and Company · Updated on 2026-03-20
36
Participants Needed
3
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight of 55 kilograms or more and body mass index between 19.0 and 40.0 kg/m2
- Healthy participants with normal liver function confirmed by history, physical exam, and screening (Group 1)
- Participants with mild, moderate, or severe hepatic impairment classified by Child-Pugh score A, B, or C
- Diagnosis of chronic hepatic impairment for more than 6 months with stable condition and no significant changes within 15 days prior to screening (Groups 2-4)
You will not qualify if you...
- History or presence of chronic or acute pancreatitis or elevated serum amylase or lipase greater than 1.5 times the upper limit of normal
- Pregnant, intending to become pregnant, or breastfeeding during the study
- For healthy participants: liver disease, clinical signs or symptoms of liver disease, acute or chronic hepatitis, or elevated AST, ALT, or total bilirubin greater than 1.5 times the upper limit of normal at screening
- Current infection with hepatitis B virus (positive HBsAg or positive HBV DNA if HBsAg negative and anti-HBc positive)
- Current infection with hepatitis C virus (positive anti-HCV and positive HCV RNA)
- Presence of active portal shunt or transjugular intrahepatic portosystemic shunt (Groups 2-4)
- Require paracentesis more than twice per month or expected need during the study (Groups 2-4)
- Evidence of spontaneous bacterial peritonitis within 6 months (Groups 2-4)
- Variceal bleeding within 3 months unless successful banding performed at least 1 month prior (Groups 2-4)
- Presence of hepatocellular carcinoma (Groups 2-4)
- Hepatic encephalopathy Grade 2 or higher (Groups 2-4)
- Total bilirubin greater than 15 mg/dL (Groups 2-4)
- ALT greater than or equal to 6 times upper limit of normal (Groups 2-4)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
2
American Research Corporation
San Antonio, Texas, United States, 78215
Actively Recruiting
3
CRU Early Phase Unit
Kistarcsa, Hungary, H-2143
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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