RecruitingPhase 1NCT06916078

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

Sponsor

Eli Lilly and Company

Enrollment

33 participants

Start Date

Apr 23, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Liver Dysfunction

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

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)
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 Criteria7

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

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