NCT06916078

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Liver Dysfunction
• Healthy

Interventions

Type	Name	Description
DRUG	Lepodisiran	Lepodisiran administered SC

Timeline

• Start date: 2025-04-23
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-04-08
• Last updated: 2026-03-23

Locations

4 sites across 2 countries: United States, Hungary

Regulatory

• FDA-regulated drug study