CompletedPhase 1

A Study of LY4268989 (MORF-057) in Healthy Participants

United States144 participantsStarted 2025-05-01

Plain-language summary

The purpose of this study is to measure the body's absorption and processing of the study drug, the study drug's effect on the body, safety, and tolerability with LY4268989 (MORF-57) in healthy participants, including Japanese and Chinese participants

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Are healthy as determined by medical evaluation including medical history, physical examination, laboratory test, electrocardiograms (ECGs), and vital signs. * Cohort 5 includes Japanese participants. To qualify, the participants must be first-generation Japanese in the US, defined as the participant's biological parents, and all the participant's biological grandparents, being of exclusive Japanese descent, and being born in Japan. * Cohort 5 includes Chinese participants. To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China. * Have a body mass index within the range of 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 particip…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 (Cohort 1) and (Cohort 5)

Timeframe: Day 1 to Day 17

PK: Area Under the Concentration Curve (AUC) of LY4268989 (Cohort 1) and (Cohort 5)

Timeframe: Day 1 to Day 17

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Cohort 1), (Cohort 3), and (Cohort 5)

Timeframe: Baseline to Study Completion (Up to Day 17)

Number of Participants with TEAEs and SAEs (Cohort 4)

Timeframe: Baseline to Study Completion (Up to Period 4, Day 4)

PK: Cmax of LY4268989 (Cohort 2)

Timeframe: Day 1 to Day 13

PK: AUC of LY4268989 (Cohort 2)

Timeframe: Day 1 to Day 13

PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 3)

Timeframe: Day 1 to Day 17

Trial details

NCT IDNCT06964776

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-17

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 (Cohort 1) and (Cohort 5)

Timeframe: Day 1 to Day 17

PK: Area Under the Concentration Curve (AUC) of LY4268989 (Cohort 1) and (Cohort 5)

Timeframe: Day 1 to Day 17

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Cohort 1), (Cohort 3), and (Cohort 5)

Timeframe: Baseline to Study Completion (Up to Day 17)

Number of Participants with TEAEs and SAEs (Cohort 4)

Timeframe: Baseline to Study Completion (Up to Period 4, Day 4)

PK: Cmax of LY4268989 (Cohort 2)

Timeframe: Day 1 to Day 13

PK: AUC of LY4268989 (Cohort 2)

Timeframe: Day 1 to Day 13

PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 3)

Timeframe: Day 1 to Day 17