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NCT Number: NCT06916078

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRU Early Phase Unit, Kistarcsa, Hungary

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lepodisiran

Drug

Lepodisiran administered SC

Other names: LY3819469

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Lepodisiran

    Time frame: Baseline Up to 9 weeks

    PK: AUC of Lepodisiran

  2. PK: Maximum Concentration (Cmax) of Lepodisiran

    Time frame: Baseline Up to 9 weeks

    PK: Cmax of Lepodisiran

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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