Recruiting
Phase 1

LY4268989

Sponsor:

Eli Lilly and Company

Code:

NCT07707375

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

LY4268989

Study Details

Brief summary:

The purpose of this study is to identify if two different tablets of LY4268989 (MORF 057) work similarly in healthy participants given different meals.

Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

There will be 18 inpatient stays at the clinical research unit (CRU). The study will last about 9 weeks.

Conditions

Healthy

Study ID

NCT07707375

Start date

Jul 20, 2026

Status verified date

Aug, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory test, electrocardiograms (ECGs), and vital signs.
  • Have a body mass index (BMI) within the range 18.0 to 32.0 kilogram/square meter (kg/m²), inclusive, at screening.

Exclusion Criteria:

  • Have a current or recent acute, active infection. For at least 30 days before screening and up to Day 1, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment.
  • Have presence of significant uncontrolled respiratory, cerebrocardiovascular, cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or psychiatric disorders, or abnormal laboratory values at screening that, in the opinion of the sponsor or investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data.
  • Are immunocompromised to an extent that participation in the study would pose an unacceptable risk to the participant as determined by the investigator.
  • Use or intend to use prescription or nonprescription medication, including dietary supplements, vitamins, herbal supplements, traditional Chinese medicine, alternative medicines, or any medication known to be moderate to strong cytochrome P450 3A4 (CYP3A) inhibitors or inducers, or organic anion transporting polypeptide 1B1 (OATP1B) inhibitors, P-gp inhibitors, or medications that are narrow therapeutic index substrates for breast cancer resistance protein (BCRP) or P-gp within 14 days or 5 half lives, whichever is longer, prior to dosing, until the end of study assessments are complete.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: LY4268989 Treatment A

Participants will receive LY4268989 single dose T1 orally with high-fat meal

experimental: LY4268989 Treatment B

Participants will receive LY4268989 single dose T2 orally with high-fat meal

experimental: LY4268989 Treatment C

Participants will receive LY4268989 single dose T2 orally in a fasted state

experimental: LY4268989 Treatment D

Participants will receive LY4268989 single dose T3 orally with high-fat meal

experimental: LY4268989 Treatment E

Participants will receive LY4268989 single dose T3 orally in a fasted state

experimental: LY4268989 Treatment F

Participants will receive LY4268989 single dose T1 orally in a fasted state

Interventions

LY4268989

Administered orally

Primary outcome measure

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 [ Time Frame: Day 1 to Day 18 ]
  • PK: Area Under the Concentration Curve (AUC) of LY4268989 [ Time Frame: Day 1 to Day 18 ]

Central Contacts and Locations

Central contacts

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

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

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Fortrea Clinical Research Unit

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

386-366-6400

Principal Investigator:

Hugh Coleman

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-20.