RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Hepatic Insufficiency
Intervention / Treatment

-

Contacts and Locations

Lake Forest

Orange County Research Center, Lake Forest, California, United States, 92630

Miami

Clinical Pharmacology of Miami, Miami, Florida, United States, 33014

Orlando

Orlando Clinical Research Center, Orlando, Florida, United States, 32809

San Antonio

American Research Corporation at Texas Liver Institute, San Antonio, Texas, United States, 78215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2025-08