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New treatment option for Hepatic Insufficiency
Official title A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.
ClinicalTrials.gov ID: NCT07401862
What this study is testing
What is LY3841136?
LY3841136 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hepatic insufficiency.
Also referred to as Eloralintide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Have hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment who are considered acceptable for...
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
- San Antonio, Texas, United States
- Kistarcsa, Hungary
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States; San Antonio, Texas, United States; Kistarcsa, Hungary. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.