A Study Comparing Two Ways of Taking Olomorasib (LY3537982) in Healthy Participants

NCT07794592 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27959J3M-MC-JZQO
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to compare how much and how quickly olomorasib gets into the bloodstream when it is taken in 2 different ways, and to check for any side effects. For each participant, the study will last about 6 weeks and will include 1 stay in the Clinical Research Unit (CRU) which consists of 7 nights.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics: Maximum Concentration (Cmax) of olomorasib

  Day 1 to Day 7

Study Arms (2)

Olomorasib test

EXPERIMENTAL

Olomorasib administered orally

Drug: Olomorasib test

Olomorasib reference

EXPERIMENTAL

Olomorasib administered orally

Drug: Olomorasib reference

Interventions

Olomorasib test DRUG

Administered orally

Also known as: LY3537982

Olomorasib test

Olomorasib reference DRUG

Administered orally

Also known as: LY3537982

Olomorasib reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Have a body mass index (BMI) within the range 18.0 to 30.0 kilograms per square meter (kg/m2)
• Participants assigned male at birth (AMAB) or assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP)
• Able to comply with the 7-night stay at the study site.

You may not qualify if:

• History or presence of any of the following conditions, such as metabolic disease, biliary disease, gastrointestinal disease, hematological disease, neurological disease, presence of hepatic disease, active cardiovascular disease or history of myocardial infarction or unstable angina within 6 months prior to the first dose of olomorasib
• Have an abnormal blood pressure or pulse rate
• Have known allergies to olomorasib or related compounds.
• Have clinically significant history of multiple or severe drug hypersensitivity reactions or drug allergies as determined by the investigator, such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine.
• History or presence of any illness or psychiatric condition that would interfere with the ability to provide informed consent or comply with study instructions,
• Show evidence of Human immunodeficiency virus (HIV) infection or positive HIV antibodies at screening.
• Have a positive hepatitis C antibody test unless a confirmatory HCV RNA test is negative.
• Have evidence of hepatitis B at screening that is, positive test for hepatitis B surface antigen, Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) or both.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

RECRUITING

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

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

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: August 28, 2026
• Primary Completion: October 1, 2026
• Study Completion: October 1, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)