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

Launched by ELI LILLY AND COMPANY · Apr 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called lepodisiran, which is given as an injection under the skin. The main goal is to learn how well lepodisiran moves into the bloodstream and how long it stays in the body, especially in people with different levels of liver function—normal, mild, moderate, or severe impairment. The researchers also want to find out how well people tolerate the medication and what side effects, if any, they may experience.

To participate in this study, individuals must weigh at least 55 kilograms and have a body mass index (BMI) between 19.0 and 42.0. Healthy participants with normal liver function and those with mild to severe liver impairment, classified by a specific scoring system (Child-Pugh score A, B, or C), may be eligible. The study will last about 9 weeks, and participants can expect regular check-ins to monitor their health and any potential side effects. It's important to note that certain medical conditions and recent participation in other studies may exclude individuals from joining.

Gender

ALL

Eligibility criteria

• 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