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Liver function may change how olomorasib works – new study investigates

NCT ID NCT06719128

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This completed Phase 1 study looked at how olomorasib, an oral drug, enters the bloodstream and leaves the body in people with mild, moderate, or severe liver impairment compared to healthy volunteers. 46 participants received a single dose. The goal is to understand if liver function affects drug levels, which could guide future dosing. Safety was also monitored.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Olomorasib (also called LY3537982), an oral drug
What this could lead to
If successful, this study could help doctors decide the right dose of olomorasib for patients with liver problems.
What could go wrong
This is an early, small study focused on drug levels, not on treating a disease. Results may not apply to real-world patients or predict safety.

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

46 people

The number who actually took part.

Started

Dec 2024

Finished

Aug 2025

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 75 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: * Males and females of non-childbearing potential. * Men or women with a body mass index of 18.0 to 40.0 kilograms per meter squared (kg/m²). * Able to comply with all study procedures, including the 5- to 6-night stays at the CRU and the follow-up phone call. * Healthy participants: In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, or clinical laboratory evaluations at screening and/or admission as assessed by the investigator (or designee). * Participants with hepatic impairment: Diagnosis of cirrhosis due to parenchymal liver disease, which is confirmed and documented by at least one of the following: medical history, physical examination, hepatic ultrasound, computed axial tomography scan, magnetic resonance imaging, and/or liver biopsy. Exclusion Criteria: * Females who are lactating or of childbearing potential. * History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor: 1. Metabolic disease 2. Gastrointestinal disease 3. Hematological disease 4. Neurological disease 5. History or presence of clinically significant cardiovascular disease. * Abnormal laboratory values determined to be clinically significant by the Investigator (or designee). * Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination. * Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1). * Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial, unless deemed acceptable by the investigator (or designee) and medical monitor. * History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.

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Conditions

The condition(s) this trial relates to.

Hepatic Insufficiency liver disorder liver failure

As listed by the trial registrant

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

Contacts and locations

Locations

  • American Research Corporation at Texas Liver Institute

    San Antonio, Texas, 78215, United States

  • Clinical Pharmacology of Miami

    Miami, Florida, 33014, United States

  • Orange County Research Center

    Lake Forest, California, 92630, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

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