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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lepodisiran Group 1 		Lepodisiran administered subcutaneously (SC)
  • Drug: Lepodisiran
    Lepodisiran administered SC
    Other names:
    • LY3819469
Experimental
Lepodisiran Group 2 		Lepodisiran administered SC
  • Drug: Lepodisiran
    Lepodisiran administered SC
    Other names:
    • LY3819469
Experimental
Lepodisiran Group 3 		Lepodisiran administered SC
  • Drug: Lepodisiran
    Lepodisiran administered SC
    Other names:
    • LY3819469
Experimental
Lepodisiran Group 4 		Lepodisiran administered SC
  • Drug: Lepodisiran
    Lepodisiran administered SC
    Other names:
    • LY3819469

Recruiting Locations

Clinical Pharmacology of Miami
Miami 4164138, Florida 4155751 33014-3616
Contact:
305-817-2900

Orlando Clinical Research Center
Orlando 4167147, Florida 4155751 32809
Contact:
407-240-7876

American Research Corporation at Texas Liver Institute
San Antonio 4726206, Texas 4736286 78215
Contact:
210-447-6228

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.