A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function
NCT ID: NCT06916078
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
33 participants
INTERVENTIONAL
2025-04-23
2026-01-31
Brief Summary
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The study will last up to approximately 9 weeks, excluding screening.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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Lepodisiran Group 1
Lepodisiran administered subcutaneously (SC)
Lepodisiran
Lepodisiran administered SC
Lepodisiran Group 2
Lepodisiran administered SC
Lepodisiran
Lepodisiran administered SC
Lepodisiran Group 3
Lepodisiran administered SC
Lepodisiran
Lepodisiran administered SC
Lepodisiran Group 4
Lepodisiran administered SC
Lepodisiran
Lepodisiran administered SC
Interventions
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Lepodisiran
Lepodisiran administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
85 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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, , Hungary
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Related Links
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Related Info
Other Identifiers
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J3L-MC-EZEH
Identifier Type: OTHER
Identifier Source: secondary_id
2024-520315-40-00
Identifier Type: OTHER
Identifier Source: secondary_id
27200
Identifier Type: -
Identifier Source: org_study_id
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