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

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

• Status: Completed
• Conditions: Hepatic Insufficiency; Healthy
• Intervention / Treatment: Drug: Olomorasib

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Lake Forest, California, United States, 92630
      • Orange County Research Center
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Texas
    • San Antonio, Texas, United States, 78215
      • American Research Corporation at Texas Liver Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olomorasib (Mild Hepatic Impairment); Olomorasib administered orally.	Drug: Olomorasib; Administered orally.; Other Names: LY3537982
Experimental: Olomorasib (Moderate Hepatic Impairment); Olomorasib administered orally.	Drug: Olomorasib; Administered orally.; Other Names: LY3537982
Experimental: Olomorasib (Severe Hepatic Impairment); Olomorasib administered orally.	Drug: Olomorasib; Administered orally.; Other Names: LY3537982
Experimental: Olomorasib (Normal Hepatic Function); Olomorasib administered orally.	Drug: Olomorasib; Administered orally.; Other Names: LY3537982

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum observed concentration (Cmax) of Olomorasib	PK: Cmax of Olomorasib	Predose on Day 1 up to 96 hours postdose
PK: Area under the concentration versus time curve from time zero to infinity (AUC0-inf) of Olomorasib	PK: AUC0-inf of Olomorasib	Predose on Day 1 up to 96 hours postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Actual): August 25, 2025
• Study Completion (Actual): August 25, 2025

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Hepatic Impairment; Olomorasib
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hepatic Insufficiency
• Other Study ID Numbers: 18677; J3M-OX-JZQF (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No