NCT06916078

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
0mo left

Started Apr 2025

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Apr 2025Jun 2026

First Submitted

Initial submission to the registry

April 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

April 23, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

April 1, 2025

Last Update Submit

March 20, 2026

Conditions

HealthyLiver Dysfunction

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Lepodisiran

    PK: AUC of Lepodisiran

    Baseline Up to 9 weeks

  • PK: Maximum Concentration (Cmax) of Lepodisiran

    PK: Cmax of Lepodisiran

    Baseline Up to 9 weeks

Study Arms (4)

Lepodisiran Group 1

EXPERIMENTAL

Lepodisiran administered subcutaneously (SC)

Drug: Lepodisiran

Lepodisiran Group 2

EXPERIMENTAL

Lepodisiran administered SC

Drug: Lepodisiran

Lepodisiran Group 3

EXPERIMENTAL

Lepodisiran administered SC

Drug: Lepodisiran

Lepodisiran Group 4

EXPERIMENTAL

Lepodisiran administered SC

Drug: Lepodisiran

Interventions

LepodisiranDRUG

Lepodisiran administered SC

Also known as: LY3819469
Lepodisiran Group 1Lepodisiran Group 2Lepodisiran Group 3Lepodisiran Group 4

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinical Pharmacology of Miami

Miami, Florida, 33014-3616, United States

RECRUITING

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

RECRUITING

American Research Corporation at Texas Liver Institute

San Antonio, Texas, 78215, United States

RECRUITING

CRU Early Phase Unit

Kistarcsa, H-2143, Hungary

RECRUITING

Related Links

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2025

First Posted

April 8, 2025

Study Start

April 23, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)HU(1)