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

Part of paid clinical trials in Miami, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT06916078
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Healthy
  • Liver Dysfunction

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

First listed
Apr 8, 2025
Start date
Apr 23, 2025
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
33 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Lepodisiran Group 1
    Lepodisiran administered subcutaneously (SC)
  • Experimental: Lepodisiran Group 2
    Lepodisiran administered SC
  • Experimental: Lepodisiran Group 3
    Lepodisiran administered SC
  • Experimental: Lepodisiran Group 4
    Lepodisiran administered SC

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Lepodisiran [ Time Frame: Baseline Up to 9 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of MiamiMiamiFlorida33014-3616-
Orlando Clinical Research CenterOrlandoFlorida32809-
American Research Corporation at Texas Liver InstituteSan AntonioTexas78215-

Find similar trials in Miami, FL

By research site
Clinical Pharmacology of Miami· Miami, FLOrlando Clinical Research Center· Orlando, FLAmerican Research Corporation at Texas Liver Institute· San Antonio, TX

Related Studies