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RecruitingNCT07794592Updated Sep 22, 2026

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

A Phase 1 interventional study of Olomorasib test and Olomorasib reference in Healthy Volunteers, sponsored by Eli Lilly and Company. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Olomorasib test

    Olomorasib administered orally

    Drug: Olomorasib test

  • Experimental
    Olomorasib reference

    Olomorasib administered orally

    Drug: Olomorasib reference

Interventions

  • DrugOlomorasib test

    Administered orally

    Also known as: LY3537982

  • DrugOlomorasib reference

    Administered orally

    Also known as: LY3537982

05

What researchers measure

Primary outcomes

  1. Pharmacokinetics: Maximum Concentration (Cmax) of olomorasib

    Time frame: Day 1 to Day 7

06

Study locations

1 of 1 sites recruiting
  • Fortrea Clinical Research Unit
    Daytona Beach, Florida 32117, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07794592
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Aug 28, 2026
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Sep 22, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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