HealthyPhase 1NCT07044271
A Study of Multiple Olomorasib (LY3537982) Capsules in Healthy Participants
A Phase 1 study testing Olomorasib in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The main purpose of this study is to measure how much olomorasib gets into the bloodstream and how long it takes the body to get rid of it. Healthy participants will take olomorasib by mouth. The study will last about 7 weeks and will include 10 back-to-back overnight stays in the research center. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Olomorasib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jul 2025to 8 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
- Body mass index (BMI): 18.0 to 30.0 kilograms per square meter (kg/m²), inclusive
- Participants assigned male at birth (AMAB) or assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP).
Who cannot join
- Females who are lactating or of childbearing potential
- Clinically significant history of any drug sensitivity, drug allergy, or food allergy
- Have used or plan to use medication within 14 days or 5 half-lives, whichever is longest, prior to admission, with the exception occasional acetaminophen at doses less than or equal to 2 g/day.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ICON
Salt Lake City, Utah, 84124
ICON Early Phase Services
San Antonio, Texas, 78209
About this study
Official title: An Open-Label, Randomized, 3-Way Crossover Study Comparing the Pharmacokinetics of Multiple Olomorasib (LY3537982) Capsules
The main purpose of this study is to measure how much olomorasib gets into the bloodstream and how long it takes the body to get rid of it. Healthy participants will take olomorasib by mouth. The study will last about 7 weeks and will include 10 back-to-back overnight stays in the research center.
- Conditions
- Healthy
- Being tested
- Olomorasib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlomorasibDrug
Also called LY3537982
Single dose
| Study group | Role | What they receive |
|---|---|---|
| Olomorasib - (Test Formulation 1) | Experimental | Olomorasib administered orally Receives: Drug: Olomorasib |
| Olomorasib - (Test Formulation 2) | Experimental | Olomorasib administered orally Receives: Drug: Olomorasib |
| Olomorasib - (Reference Formulation) | Active comparator | Olomorasib administered orally Receives: Drug: Olomorasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Time t (AUC[0-tlast]) of Olomorasib
PK: AUC(0-tlast) of Olomorasib
Measured: From Day 1, Predose up to 72 hours Postdose
PK: Area Under the Concentration versus Time Curve from Zero to Infinity (AUC[0-∞]) of Olomorasib
PK: AUC(0-∞) of Olomorasib
Measured: From Day 1, Predose up to 72 hours Postdose
PK: Maximum Observed Drug Concentration (Cmax) of Olomorasib
PK: Cmax of Olomorasib
Measured: From Day 1, Predose up to 72 hours Postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start11 Jul 2025
- Primary completion8 Nov 2025
- Study completion8 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- 3-way crossover study
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
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
- NCT07044271
- Sponsor's protocol ID
- 27282
- Other IDs
- J3M-OX-JZQK
- Status last verified
- May 2026
- First submitted
- 26 Jun 2025
- Last updated
- 29 May 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, 3-Way Crossover Study Comparing the Pharmacokinetics of Multiple Olomorasib (LY3537982) Capsules
- ClinicalTrials.gov ID
- NCT07044271
- Acronym / sponsor ID
- 27282
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 8 Nov 2025 (actual)
- Study completion
- 8 Nov 2025 (actual)
- First posted
- 29 Jun 2025 (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 measure how much olomorasib gets into the bloodstream and how long it takes the body to get rid of it. Healthy participants will take olomorasib by mouth. The study will last about 7 weeks and will include 10 back-to-back overnight stays in the research center.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3-way crossover study
| Arm | Type | Receives |
|---|---|---|
| Olomorasib - (Test Formulation 1) | Experimental | Drug: OlomorasibOlomorasib administered orally |
| Olomorasib - (Test Formulation 2) | Experimental | Drug: OlomorasibOlomorasib administered orally |
| Olomorasib - (Reference Formulation) | Active comparator | Drug: OlomorasibOlomorasib administered orally |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
- Body mass index (BMI): 18.0 to 30.0 kilograms per square meter (kg/m²), inclusive
- Participants assigned male at birth (AMAB) or assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP).
Key exclusion criteria (3 listed)
- Females who are lactating or of childbearing potential
- Clinically significant history of any drug sensitivity, drug allergy, or food allergy
- Have used or plan to use medication within 14 days or 5 half-lives, whichever is longest, prior to admission, with the exception occasional acetaminophen at doses less than or equal to 2 g/day.
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 |
|---|---|---|
| OlomorasibAlso: LY3537982Single dose | Drug | Olomorasib - (Reference Formulation), Olomorasib - (Test Formulation 1), Olomorasib - (Test Formulation 2) |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Time t (AUC[0-tlast]) of Olomorasib
Time frame: From Day 1, Predose up to 72 hours Postdose
PK: AUC(0-tlast) of Olomorasib
PK: Area Under the Concentration versus Time Curve from Zero to Infinity (AUC[0-∞]) of Olomorasib
Time frame: From Day 1, Predose up to 72 hours Postdose
PK: AUC(0-∞) of Olomorasib
PK: Maximum Observed Drug Concentration (Cmax) of Olomorasib
Time frame: From Day 1, Predose up to 72 hours Postdose
PK: Cmax of Olomorasib
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 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. This study is not recruiting at the moment.
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
2 sites 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 in people with Healthy, run by Eli Lilly and Company at 2 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Time t (AUC[0-tlast]) of Olomorasib (time frame: From Day 1, Predose up to 72 hours Postdose). The study lists 3 primary outcomes in all. 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 29 May 2026.