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

Phase 1

Not yet recruiting

• Conditions: Liver Dysfunction; Healthy
• Interventions: Drug: Lepodisiran

• Registration Number: NCT06916078
• Lead Sponsor: Eli Lilly and Company

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Lepodisiran Group 1	Lepodisiran	Lepodisiran administered subcutaneously (SC)
Lepodisiran Group 2	Lepodisiran	Lepodisiran administered SC
Lepodisiran Group 3	Lepodisiran	Lepodisiran administered SC
Lepodisiran Group 4	Lepodisiran	Lepodisiran administered SC

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Lepodisiran	Baseline Up to 9 weeks	PK: AUC of Lepodisiran
PK: Maximum Concentration (Cmax) of Lepodisiran	Baseline Up to 9 weeks	PK: Cmax of Lepodisiran

Trial Locations

Locations (4)

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

American Research Corporation at Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States

CRU Early Phase Unit; 🇭🇺 Kistarcsa, Pest, Hungary