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OpenTrials
Completed

NCT Number: NCT06719128

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orange County Research Center, Lake Forest, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Metabolic disease
  • Gastrointestinal disease
  • Hematological disease
  • Neurological disease
  • 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.

Treatment and study plan

Olomorasib

Drug

Administered orally.

Other names: LY3537982

Primary outcomes

  1. Pharmacokinetics (PK): Maximum observed concentration (Cmax) of Olomorasib

    Time frame: Predose on Day 1 up to 96 hours postdose

    PK: Cmax of Olomorasib

  2. PK: Area under the concentration versus time curve from time zero to infinity (AUC0-inf) of Olomorasib

    Time frame: Predose on Day 1 up to 96 hours postdose

    PK: AUC0-inf of Olomorasib

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2024
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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