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NCT Number: NCT07607483

A Study of LY4065967 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.

Recruiting

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit, Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

LY4065967 Tablet

Drug

Administered orally

LY4065967 Formulated Capsule

Drug

Administered orally

LY4065967 Capsule

Drug

Administered orally

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967

    Time frame: Baseline Up to Day 17

  2. PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t [AUC(0- tlast)]

    Time frame: Baseline Up to Day 17

  3. PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity [AUC(0-∞)]

    Time frame: Baseline Up to Day 17

Secondary outcomes

  1. PK: Time of Maximum Observed Drug Concentration (tmax)

    Time frame: Baseline Up to Day 17

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-Label, Crossover Study to Investigate the Relative Bioavailability of LY4065967 Formulations in Healthy Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 26, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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