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A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants

An Open-Label, Nonrandomized, Single-Dose, Safety and Pharmacokinetic Study of LY3537982 in Participants With Hepatic Impairment and Healthy Participants

NCT06719128•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to assess how olomorasib gets into the blood stream and how long it takes the body to remove it when administered to participants with mild, moderate and severe impaired liver function compared to participants with normal liver function. The safety and tolerability of olomorasib will also be evaluated. The study may last up to 6 weeks for each participant including the screening period.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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).
+2 more criteria

Locations (4)

Orange County Research Center

Lake Forest, California, United States

Clinical Pharmacology of Miami

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

American Research Corporation at Texas Liver Institute

San Antonio, Texas, United States

Key Dates

Start Date

December 6, 2024

Primary Completion Date

August 25, 2025

Completion Date

August 25, 2025

Last Updated

September 22, 2025

Enrollment

ACTUAL participants

Conditions

Hepatic InsufficiencyHealthy

Interventions

Olomorasib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants

Inclusion Criteria

Exclusion Criteria

Collection of Data and Samples From Healthy Donors for Use in Translational Research

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