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

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

1

Condition

Liver Failure

Liver Disease

Primary Biliary Cholangitis

Treatment

Olomorasib

Clinical Study ID

NCT06719128
18677
J3M-OX-JZQF
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 theCRU and the follow-up phone call.

  • Healthy participants: In good health, determined by no clinically significantfindings from medical history, physical examination, 12-lead ECG, vital signmeasurements, or clinical laboratory evaluations at screening and/or admission asassessed by the investigator (or designee).

  • Participants with hepatic impairment: Diagnosis of cirrhosis due to parenchymalliver disease, which is confirmed and documented by at least one of the following:medical history, physical examination, hepatic ultrasound, computed axial tomographyscan, magnetic resonance imaging, and/or liver biopsy.

Exclusion

Exclusion Criteria:

  • Females who are lactating or of childbearing potential.

  • History or presence of any of the following, deemed clinically significant by theInvestigator (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 theInvestigator (or designee).

  • Clinically significant abnormality, as determined by the Investigator (or designee),from physical examination.

  • Participation in any other investigational study drug trial involving administrationof any investigational drug in the past 30 days or 5 half-lives, whichever waslonger, prior to the first dose administration (Day 1).

  • Use or intention to use any prescription or over-the-counter medications within 14days prior to the first dose administration (Day 1) and through end of trial, unlessdeemed acceptable by the investigator (or designee) and medical monitor.

  • History or presence, upon clinical evaluation, of any illness that, in the opinionof the Investigator, would interfere with the ability to provide informed consent orcomply with study instructions, or that might confound the interpretation of thestudy results, or put the participant at undue risk.

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Olomorasib
Phase: 1
Study Start date:
December 06, 2024
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Orange County Research Center

    Lake Forest, California 92630
    United States

    Active - Recruiting

  • Clinical Pharmacology of Miami

    Miami, Florida 33014
    United States

    Active - Recruiting

  • Orlando Clinical Research Center

    Orlando, Florida 32809
    United States

    Active - Recruiting

  • American Research Corporation at Texas Liver Institute

    San Antonio, Texas 78215
    United States

    Active - Recruiting

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