A Study of LY4065967 in Healthy Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: LY4065967 Capsule; Drug: LY4065967 Tablet; Drug: LY4065967 Formulated Capsule

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Fortrea Clinical Research Unit
      • Contact: Phone Number: 386-366-6400
      • Principal Investigator: Hugh Coleman
  • Texas
    • Dallas, Texas, United States, 75247
      • Fortrea Clinical Research Unit
      • Contact: Phone Number: 214-647-9375
      • Principal Investigator: Gene Voskuhl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY4065967 (Reference); Administered orally as a capsule in one of three treatment periods.	Drug: LY4065967 Capsule; Administered orally
Experimental: LY4065967 (Test 1); Administered orally as a tablet in one of three treatment periods.	Drug: LY4065967 Tablet; Administered orally
Experimental: LY4065967 (Test 2); Administered orally as a formulated capsule in one of three treatment periods.	Drug: LY4065967 Formulated Capsule; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967	Baseline Up to Day 17
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t [AUC(0- tlast)]	Baseline Up to Day 17
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity [AUC(0-∞)]	Baseline Up to Day 17

Secondary Outcome Measures

Outcome Measure	Time Frame
PK: Time of Maximum Observed Drug Concentration (tmax)	Baseline Up to Day 17

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 27902; J4X-MC-LWCC (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No