NCT07607483

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
1mo left

Started Jun 2026

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jun 2026Jul 2026

First Submitted

Initial submission to the registry

May 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 19, 2026

Last Update Submit

May 19, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • PK: Time of Maximum Observed Drug Concentration (tmax)

    Baseline Up to Day 17

Study Arms (3)

LY4065967 (Reference)

EXPERIMENTAL

Administered orally as a capsule in one of three treatment periods.

Drug: LY4065967 Capsule

LY4065967 (Test 1)

EXPERIMENTAL

Administered orally as a tablet in one of three treatment periods.

Drug: LY4065967 Tablet

LY4065967 (Test 2)

EXPERIMENTAL

Administered orally as a formulated capsule in one of three treatment periods.

Drug: LY4065967 Formulated Capsule

Interventions

LY4065967 TabletDRUG

Administered orally

LY4065967 (Test 1)
LY4065967 Formulated CapsuleDRUG

Administered orally

LY4065967 (Test 2)
LY4065967 CapsuleDRUG

Administered orally

LY4065967 (Reference)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Study Officials

  • 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 DIRECTOR

Central Study Contacts

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

CONTACT

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 26, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)