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

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Healthy; Liver Dysfunction

Treatments: Drug: Lepodisiran

Study type: Interventional

Funder types: Industry

Identifiers

NCT06916078

J3L-MC-EZEH (Other Identifier)

27200

2024-520315-40-00 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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33 participants in 4 patient groups

Lepodisiran Group 1

Experimental group

Description:

Lepodisiran administered subcutaneously (SC)

Treatment:

Drug: Lepodisiran

Lepodisiran Group 2

Experimental group

Description:

Lepodisiran administered SC

Treatment:

Drug: Lepodisiran

Lepodisiran Group 3

Experimental group

Description:

Lepodisiran administered SC

Treatment:

Drug: Lepodisiran

Lepodisiran Group 4

Experimental group

Description:

Lepodisiran administered SC

Treatment:

Drug: Lepodisiran