Actively Recruiting
A Phase 1 Study of Lepodisiran in Participants With Normal or Mild to Severe Liver Function Impairment
Led by Eli Lilly and Company · Updated on 2026-05-19
33
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the behavior and safety of lepodisiran, a drug given as a subcutaneous injection, in adults with varying degrees of liver function, including normal, mild, moderate, and severe impairment. The study aims to understand how much lepodisiran enters the bloodstream and how long it stays in the body, as well as to observe any side effects in these groups. This is a Phase 1, open-label study conducted by Eli Lilly and Company. Participants will receive a single dose of lepodisiran injected under the skin. The study includes four groups based on liver function: one group with normal liver health and three groups with mild, moderate, or severe liver impairment, classified by Child-Pugh scores. The treatment is given once, and the study design is sequential without randomization or blinding. The study lasts up to about 9 weeks, excluding screening, during which participants will have their blood sampled to measure lepodisiran levels and monitor its clearance from the body. Researchers will assess pharmacokinetics, including the concentration of lepodisiran over time and its maximum concentration. Participants will also be monitored for safety and side effects throughout the study period.
CONDITIONS
Brief 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...
- Weigh at least 55 kilograms and have a body mass index between 19.0 and 42.0 kg/m²
- For Group 1: Healthy participants with normal liver function
- For Groups 2 to 4: Participants with mild, moderate, or severe liver impairment diagnosed by a doctor using Child-Pugh scores
- Age between 18 and 85 years
You will not qualify if you...
- Significant history or current cardiovascular, respiratory, hepatic (for Group 1 only), renal, gastrointestinal, endocrine, hematological, or neurological disorders
- Severe atopy or history of multiple or severe drug allergies
- Known allergies to lepodisiran or its components
- History or current psychiatric disorders
- Any cancer within the past 5 years
- Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m²
- Participation in another 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 weeks
Participants receive Lepodisiran administered subcutaneously.
Multiple visits during treatment period
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
P
Physicians interested in becoming principal investigators please 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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