Status:
RECRUITING
A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function
Lead Sponsor:
Eli Lilly and Company
Conditions:
Liver Dysfunction
Healthy
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06916078
Start Date
April 23 2025
End Date
January 1 2026
Last Update
December 9 2025
Active Locations (4)
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1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014-3616
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
3
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States, 78215
4
CRU Early Phase Unit
Kistarcsa, Hungary, H-2143