Healthy VolunteersPhase 1NCT07794592
A Study Comparing Two Ways of Taking Olomorasib (LY3537982) in Healthy Participants
A Phase 1 study testing Olomorasib test and Olomorasib reference in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Olomorasib test and Olomorasib reference
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2026to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
United States1 site, 1 recruiting
- Recruiting
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
About this study
Official title: An Open-Label Randomized Study to Evaluate Olomorasib Administration as an Intact Oral Capsule and as a Water Dispersion to Healthy Participants.
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
- Being tested
- Olomorasib test, Olomorasib reference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olomorasib testDrug
Also called LY3537982
Administered orally
Olomorasib referenceDrug
Also called LY3537982
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Olomorasib test | Experimental | Olomorasib administered orally Receives: Drug: Olomorasib test |
| Olomorasib reference | Experimental | Olomorasib administered orally Receives: Drug: Olomorasib reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Maximum Concentration (Cmax) of olomorasib
Measured: Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start28 Aug 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794592
- Sponsor's protocol ID
- 27959
- Other IDs
- J3M-MC-JZQO
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Randomized Study to Evaluate Olomorasib Administration as an Intact Oral Capsule and as a Water Dispersion to Healthy Participants.
- ClinicalTrials.gov ID
- NCT07794592
- Acronym / sponsor ID
- 27959
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olomorasib test | Experimental | Drug: Olomorasib testOlomorasib administered orally |
| Olomorasib reference | Experimental | Drug: Olomorasib referenceOlomorasib administered orally |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olomorasib testAlso: LY3537982Administered orally | Drug | Olomorasib test |
| Olomorasib referenceAlso: LY3537982Administered orally | Drug | Olomorasib reference |
Primary outcome
Pharmacokinetics: Maximum Concentration (Cmax) of olomorasib
Time frame: Day 1 to Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olomorasib test and Olomorasib reference in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics: Maximum Concentration (Cmax) of olomorasib (time frame: Day 1 to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.