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
Eli Lilly and Company
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.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- 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 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 o…
Interventions
- DrugLY3841136
Administered SC
Locations (3)
- Orlando Clinical Research CenterOrlando, Florida
- American Research CorporationSan Antonio, Texas
- CRU Early Phase UnitKistarcsa