HealthyPhase 1NCT07607483
A Study of LY4065967 in Healthy Participants
A Phase 1 study testing LY4065967 Tablet, LY4065967 Formulated Capsule and LY4065967 Capsule 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 compare 3 different forms of LY4065967 - a tablet and 2 types of capsule - to see how much and how quickly each gets into the bloodstream after it is swallowed, 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
- What is being tested?
- LY4065967 Tablet, LY4065967 Formulated Capsule and LY4065967 Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2026to 27 Jul 2026
- 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
- Are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- Have clinical laboratory test results within normal reference range for the population or investigative site.
- Have an electrocardiogram (ECG) at screening considered to be within acceptable limits by the investigator.
- Have a body mass index within the range 18.0 to 35.0 kilograms per square meter (kg/m²) (inclusive).
- Individuals assigned male at birth (AMAB) or assigned female at birth (AFAB) may participate in this trial.
- Have venous access sufficient to allow for blood sampling.
Who cannot join
- Have a history of or current clinically significant medical conditions, including cardiovascular disease, electrolyte abnormalities, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disorders that, in the judgment of the investigator, could predispose to arrhythmia, pose a risk with study participation, significantly alter the absorption, metabolism, or elimination of the study drug, or interfere with the interpretation of study data.
- Have systolic blood pressure of 140 millimeters of mercury (mmHg) or greater and diastolic blood pressure of 90 mmHg or greater at screening.
- Have a history of clinically significant known allergies to LY4065967, related compounds, or any components of the formulation, or history of significant atopy.
- Have a history of alcohol, opioids, stimulants or hallucinogens use disorder within 2 years prior to screening or a current use disorder by Diagnostic and Statistical Manual of Mental Disorders (APA 2013).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fortrea Clinical Research Unit
Dallas, Texas, 75247
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
About this study
Official title: A Phase 1, Randomized, Open-Label, Crossover Study to Investigate the Relative Bioavailability of LY4065967 Formulations in Healthy Participants
The main purpose of this study is to compare 3 different forms of LY4065967 - a tablet and 2 types of capsule - to see how much and how quickly each gets into the bloodstream after it is swallowed, and to check for any side effects. For each participant, the study will last about 7 weeks and will include 3 stays in the Clinical Research Unit (CRU). Each stay will last 3 nights.
- Conditions
- Healthy
- Being tested
- LY4065967 Tablet, LY4065967 Formulated Capsule, LY4065967 Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4065967 TabletDrug
Administered orally
LY4065967 Formulated CapsuleDrug
Administered orally
LY4065967 CapsuleDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY4065967 (Reference) | Experimental | Administered orally as a capsule in one of three treatment periods. Receives: Drug: LY4065967 Capsule |
| LY4065967 (Test 1) | Experimental | Administered orally as a tablet in one of three treatment periods. Receives: Drug: LY4065967 Tablet |
| LY4065967 (Test 2) | Experimental | Administered orally as a formulated capsule in one of three treatment periods. Receives: Drug: LY4065967 Formulated Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967
Measured: Baseline Up to Day 17
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t [AUC(0- tlast)]
Measured: Baseline Up to Day 17
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity [AUC(0-∞)]
Measured: Baseline Up to Day 17
Secondary outcomes (1)
PK: Time of Maximum Observed Drug Concentration (tmax)
Measured: Baseline Up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start3 Jun 2026
- Primary completion27 Jul 2026
- Study completion27 Jul 2026
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
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT07607483
- Sponsor's protocol ID
- 27902
- Other IDs
- J4X-MC-LWCC
- Status last verified
- Aug 2026
- First submitted
- 19 May 2026
- Last updated
- 19 Aug 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Crossover Study to Investigate the Relative Bioavailability of LY4065967 Formulations in Healthy Participants
- ClinicalTrials.gov ID
- NCT07607483
- Acronym / sponsor ID
- 27902
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 26 May 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 3 different forms of LY4065967 - a tablet and 2 types of capsule - to see how much and how quickly each gets into the bloodstream after it is swallowed, and to check for any side effects. For each participant, the study will last about 7 weeks and will include 3 stays in the Clinical Research Unit (CRU). Each stay will last 3 nights.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY4065967 (Reference) | Experimental | Drug: LY4065967 CapsuleAdministered orally as a capsule in one of three treatment periods. |
| LY4065967 (Test 1) | Experimental | Drug: LY4065967 TabletAdministered orally as a tablet in one of three treatment periods. |
| LY4065967 (Test 2) | Experimental | Drug: LY4065967 Formulated CapsuleAdministered orally as a formulated capsule in one of three treatment periods. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- Have clinical laboratory test results within normal reference range for the population or investigative site.
- Have an electrocardiogram (ECG) at screening considered to be within acceptable limits by the investigator.
- Have a body mass index within the range 18.0 to 35.0 kilograms per square meter (kg/m²) (inclusive).
- Individuals assigned male at birth (AMAB) or assigned female at birth (AFAB) may participate in this trial.
Key exclusion criteria (4 listed)
- Have a history of or current clinically significant medical conditions, including cardiovascular disease, electrolyte abnormalities, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disorders that, in the judgment of the investigator, could predispose to arrhythmia, pose a risk with study participation, significantly alter the absorption, metabolism, or elimination of the study drug, or interfere with the interpretation of study data.
- Have systolic blood pressure of 140 millimeters of mercury (mmHg) or greater and diastolic blood pressure of 90 mmHg or greater at screening.
- Have a history of clinically significant known allergies to LY4065967, related compounds, or any components of the formulation, or history of significant atopy.
- Have a history of alcohol, opioids, stimulants or hallucinogens use disorder within 2 years prior to screening or a current use disorder by Diagnostic and Statistical Manual of Mental Disorders (APA 2013).
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 |
|---|---|---|
| LY4065967 TabletAdministered orally | Drug | LY4065967 (Test 1) |
| LY4065967 Formulated CapsuleAdministered orally | Drug | LY4065967 (Test 2) |
| LY4065967 CapsuleAdministered orally | Drug | LY4065967 (Reference) |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967
Time frame: Baseline Up to Day 17
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t [AUC(0- tlast)]
Time frame: Baseline Up to Day 17
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity [AUC(0-∞)]
Time frame: Baseline Up to Day 17
1 secondary outcome
PK: Time of Maximum Observed Drug Concentration (tmax)
Time frame: Baseline Up to Day 17
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 19 Aug 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 LY4065967 Tablet, LY4065967 Formulated Capsule and LY4065967 Capsule 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 6 inclusion and 4 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 19 Aug 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): Maximum Concentration (Cmax) of LY4065967 (time frame: Baseline Up to Day 17). 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 19 Aug 2026.