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

NCT06719128 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18677J3M-OX-JZQF
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hepatic Insufficiency; Healthy

Keywords

Olomorasib; Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Olomorasib (Mild Hepatic Impairment)

EXPERIMENTAL

Olomorasib administered orally.

Drug: Olomorasib

Olomorasib (Moderate Hepatic Impairment)

EXPERIMENTAL

Olomorasib administered orally.

Drug: Olomorasib

Olomorasib (Severe Hepatic Impairment)

EXPERIMENTAL

Olomorasib administered orally.

Drug: Olomorasib

Olomorasib (Normal Hepatic Function)

EXPERIMENTAL

Olomorasib administered orally.

Drug: Olomorasib

Interventions

Olomorasib DRUG

Administered orally.

Also known as: LY3537982

Olomorasib (Mild Hepatic Impairment); Olomorasib (Moderate Hepatic Impairment); Olomorasib (Normal Hepatic Function); Olomorasib (Severe Hepatic Impairment)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

American Research Corporation at Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: December 6, 2024
• Primary Completion: August 25, 2025
• Study Completion: August 25, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)