A Study of LY4268989 (MORF 057) in Healthy Participants

A Phase 1 Study to Investigate the Pharmacokinetics, Safety and Tolerability of LY4268989 (MORF-057) in Healthy Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: LY4268989

• Study Type: Interventional
• Enrollment (Estimated): 50
• 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

Participation Criteria

Eligibility Criteria

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

Description

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 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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY4268989 Treatment A; Participants will receive LY4268989 single dose T1 orally with high-fat meal	Drug: LY4268989; Administered orally
Experimental: LY4268989 Treatment B; Participants will receive LY4268989 single dose T2 orally with high-fat meal	Drug: LY4268989; Administered orally
Experimental: LY4268989 Treatment C; Participants will receive LY4268989 single dose T2 orally in a fasted state	Drug: LY4268989; Administered orally
Experimental: LY4268989 Treatment D; Participants will receive LY4268989 single dose T3 orally with high-fat meal	Drug: LY4268989; Administered orally
Experimental: LY4268989 Treatment E; Participants will receive LY4268989 single dose T3 orally in a fasted state	Drug: LY4268989; Administered orally
Experimental: LY4268989 Treatment F; Participants will receive LY4268989 single dose T1 orally in a fasted state	Drug: LY4268989; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 27850; J6E-MC-KWAP (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