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NCT06916078

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

Completed
PHASE1Ages 18–85InterventionalBasic science
Eli Lilly and Company
~30 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Lepodisiran

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Lepodisiran
Measured over Baseline Up to 9 weeks
+1 more outcome measured

Conditions

Liver Dysfunction
Healthy

Explore related trials

HealthyLiver Dysfunction

Where it's being run

4 sites across 3 states
Florida2
Texas1
Hungary1

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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)
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

What this trial measures

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LepodisiranBaseline Up to 9 weeks

    PK: AUC of Lepodisiran

  • PK: Maximum Concentration (Cmax) of LepodisiranBaseline Up to 9 weeks

    PK: Cmax of Lepodisiran