Liver function may change how olomorasib works – new study investigates
NCT ID NCT06719128
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
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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
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Orange County Research Center
Lake Forest, California, 92630, United States
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Orlando Clinical Research Center
Orlando, Florida, 32809, United States
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