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RECRUITING
NCT06916078
PHASE1

A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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

Interventions

DRUG

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