A Study of LY4268989 (MORF 057) in Healthy Participants

NCT07707375 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27850J6E-MC-KWAP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989

  Day 1 to Day 18

• PK: Area Under the Concentration Curve (AUC) of LY4268989

  Day 1 to Day 18

Study Arms (6)

LY4268989 Treatment A

EXPERIMENTAL

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

Drug: LY4268989

LY4268989 Treatment B

EXPERIMENTAL

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

Drug: LY4268989

LY4268989 Treatment C

EXPERIMENTAL

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

Drug: LY4268989

LY4268989 Treatment D

EXPERIMENTAL

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

Drug: LY4268989

LY4268989 Treatment E

EXPERIMENTAL

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

Drug: LY4268989

LY4268989 Treatment F

EXPERIMENTAL

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

Drug: LY4268989

Interventions

LY4268989 DRUG

Administered orally

LY4268989 Treatment A; LY4268989 Treatment B; LY4268989 Treatment C; LY4268989 Treatment D; LY4268989 Treatment E; LY4268989 Treatment F

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, 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

1-317-615-4559; LillyTrials@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: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)