RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Multicenter, Sequential-Design, Single-Dose, Open-Label Study of Lepodisiran in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment

Quick Facts

Study Start:2025-04-23

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06916078

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

CONTACT

3176154559

clinical_inquiry_hub@lilly.com

Principal Investigator

Contact Lilly at 1-800-LillyRx (1-800-545-5979)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

Clinical Pharmacology of Miami

Miami, Florida, 33014-3616

United States

Orlando Clinical Research Center

Orlando, Florida, 32809

United States

American Research Corporation at Texas Liver Institute

San Antonio, Texas, 78215

United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

Contact Lilly at 1-800-LillyRx (1-800-545-5979), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-23

Study Completion Date2026-01

Study Record Updates

Study Start Date2025-04-23

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Liver Dysfunction
Healthy