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Liver health may change how this drug works

NCT ID NCT06916078

Knowledge-focused Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study looks at how lepodisiran enters the blood and leaves the body in people with mild, moderate, or severe liver problems compared to those with healthy livers. About 33 adults will receive a single injection under the skin. The goal is to understand how liver function affects the drug and what side effects may occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

30 people

The number who actually took part.

Started

Apr 2025

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

liver disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy Liver dysfunction

Contacts and locations

Locations

  • American Research Corporation at Texas Liver Institute

    San Antonio, Texas, 78215, United States

  • CRU Early Phase Unit

    Kistarcsa, H-2143, Hungary

  • Clinical Pharmacology of Miami

    Miami, Florida, 33014-3616, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.