New drug study aims to see how liver health affects medication
NCT ID NCT07401862
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-stage study is testing a single dose of the drug eloralintide in 36 people with different levels of liver function—from healthy to severely impaired. Researchers want to see how the body absorbs and processes the drug and whether it causes side effects. The goal is to understand how liver damage might change the way the drug works, which could help guide future dosing recommendations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- eloralintide (LY3841136)
- What this could lead to
- If successful, this study will help determine safe dosing of eloralintide for people with liver problems, potentially guiding future treatment use.
- What could go wrong
- This is a very early Phase 1 study with only 36 participants. It is designed to measure drug levels and safety, not to treat any disease. Results may not apply to broader populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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American Research Corporation
RECRUITINGSan Antonio, Texas, 78215, United States
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CRU Early Phase Unit
RECRUITINGKistarcsa, H-2143, Hungary
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Orlando Clinical Research Center
RECRUITINGOrlando, Florida, 32809, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can two experimental drugs be used safely in people with cirrhosis?
- Can a damaged liver change how a new drug works?
- Liver health and drug processing: a closer look at casdatifan
- Liver function and drug dosing: a closer look at ulonivirine
- Liver function may change how mavorixafor works in the body