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A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function
Sponsor: Eli Lilly and Company
Summary
The main purpose of this study is to evaluate how much lepodisiran gets into the blood stream and how long it takes the body to get rid of it when given as a subcutaneous (SC) injection under the skin to participants with mild, moderate, or severe liver function impairment compared to participants with normal liver function. The study will also evaluate how well lepodisiran is tolerated and what side effects may occur in these participants. The study will last up to approximately 9 weeks, excluding screening.
Official title: A Phase 1, Multicenter, Sequential-Design, Single-Dose, Open-Label Study of Lepodisiran in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2025-04-23
Completion Date
2026-06
Last Updated
2026-03-23
Healthy Volunteers
Yes
Conditions
Interventions
Lepodisiran
Lepodisiran administered SC
Locations (4)
Clinical Pharmacology of Miami
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States
CRU Early Phase Unit
Kistarcsa, Hungary