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

May 18, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Hungary
      • Kistarcsa, Hungary, H-2143
        • Recruiting
        • CRU Early Phase Unit
        • Principal Investigator:
          • Geza Lakner
        • Contact:
          • Phone Number: +36 28 999 540
  • United States
    • Florida
      • Miami, Florida, United States, 33014-3616
        • Recruiting
        • Clinical Pharmacology of Miami
        • Principal Investigator:
          • Alexander Prezioso
        • Contact:
          • Phone Number: 305-817-2900
      • Orlando, Florida, United States, 32809
        • Recruiting
        • Orlando Clinical Research Center
        • Principal Investigator:
          • Thomas Marbury
        • Contact:
          • Phone Number: 407-240-7876
    • Texas
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • American Research Corporation at Texas Liver Institute
        • Principal Investigator:
          • Eric Lawitz
        • Contact:
          • Phone Number: 210-447-6228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Have a body weight of 55 kilogram (kg) or more and body mass index within the range 19.0 to 42.0 kilogram per square meter (kg/m²)

  • Additional Inclusion Criteria for Participants Without Hepatic Impairment in Group 1:

    • Healthy participants with clinically normal hepatic function

  • For Participants with Mild to Severe Hepatic Impairment in Groups 2 through 4:

    • Participants with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment). Diagnosis of chronic hepatic impairment of greater than 6 months, per physician diagnosis and standard-of-care practice

Exclusion Criteria:

  • Have significant history of, or current, cardiovascular (CV), respiratory, hepatic (hepatic applies to Group 1 only), renal, gastrointestinal, endocrine, hematological, or neurological disorders
  • Have severe atopy or a history of clinically significant multiple or severe drug allergies
  • Have known allergies to lepodisiran, related compounds, or any components of the formulation
  • Have a history of, or current, psychiatric disorders
  • Have had any malignancy within the past 5 years
  • Have estimated glomerular filtration rate (eGFR) less than 60 milliliters per minute per 1.73 m² (mL/min/1.73 m²) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
  • Have participated, within the last 1 month, in a clinical study involving an investigational product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lepodisiran Group 1
Lepodisiran administered subcutaneously (SC)
Drug: Lepodisiran
Lepodisiran administered SC
Other Names:
  • LY3819469
Experimental: Lepodisiran Group 2
Lepodisiran administered SC
Drug: Lepodisiran
Lepodisiran administered SC
Other Names:
  • LY3819469
Experimental: Lepodisiran Group 3
Lepodisiran administered SC
Drug: Lepodisiran
Lepodisiran administered SC
Other Names:
  • LY3819469
Experimental: Lepodisiran Group 4
Lepodisiran administered SC
Drug: Lepodisiran
Lepodisiran administered SC
Other Names:
  • LY3819469

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Lepodisiran
Time Frame: Baseline Up to 9 weeks
PK: AUC of Lepodisiran
Baseline Up to 9 weeks
PK: Maximum Concentration (Cmax) of Lepodisiran
Time Frame: Baseline Up to 9 weeks
PK: Cmax of Lepodisiran
Baseline Up to 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27200
  • J3L-MC-EZEH (Other Identifier: Eli Lilly and Company)
  • 2024-520315-40-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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