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
Recruiting
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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

Start date
Apr 23, 2025
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 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 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (3)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of MiamiMiamiFlorida33014-3616
305-817-2900
Alexander Prezioso (PRINCIPAL_INVESTIGATOR)
Orlando Clinical Research CenterOrlandoFlorida32809
407-240-7876
Thomas Marbury (PRINCIPAL_INVESTIGATOR)
American Research Corporation at Texas Liver InstituteSan AntonioTexas78215
210-447-6228
Eric Lawitz (PRINCIPAL_INVESTIGATOR)

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

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