Actively Recruiting
A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function
Led by Eli Lilly and Company · Updated on 2026-03-23
33
Participants Needed
4
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight of 55 kilograms (kg) or more and body mass index (BMI) between 19.0 and 42.0 kg/m²
- Healthy participants with normal liver function for Group 1
- Participants with mild, moderate, or severe liver impairment (Child-Pugh score A, B, or C) diagnosed for more than 6 months for Groups 2 to 4
You will not qualify if you...
- Significant history or current cardiovascular, respiratory, hepatic (Group 1 only), renal, gastrointestinal, endocrine, blood, or neurological disorders
- Severe atopy or history of multiple or severe drug allergies
- Known allergies to lepodisiran, related compounds, or any formulation components
- History or current psychiatric disorders
- Any cancer or malignancy within the past 5 years
- Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m²
- Participation in a clinical study involving an investigational product within the last month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014-3616
Actively Recruiting
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
3
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
4
CRU Early Phase Unit
Kistarcsa, Hungary, H-2143
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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