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
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 36
- Locations
- 3
- Primary Endpoint
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3841136
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
- •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
Arms & Interventions
Eloralintide (Normal Hepatic Function)
Eloralintide administered subcutaneously (SC)
Intervention: LY3841136 (Drug)
Eloralintide (Mild Hepatic Impairment)
Eloralintide administered SC
Intervention: LY3841136 (Drug)
Eloralintide (Moderate Hepatic Impairment)
Eloralintide administered SC
Intervention: LY3841136 (Drug)
Eloralintide (Severe Hepatic Impairment)
Eloralintide administered SC
Intervention: LY3841136 (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported