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OpenTrials
Completed

NCT Number: NCT06964776

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel ACT

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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, or alternative medicines, within 14 days or 5 half-lives (whichever is longer), prior to dosing, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study

Treatment and study plan

LY4268989

Drug

Administered orally

Placebo

Drug

Administered placebo

midazolam

Drug

Administered orally

Primary outcomes

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

    Time frame: Day 1 to Day 17

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

    Time frame: Day 1 to Day 17

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

    Time frame: Baseline to Study Completion (Up to Day 17)

    A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module

  4. Number of Participants with TEAEs and SAEs (Cohort 4)

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

    A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module

  5. PK: Cmax of LY4268989 (Cohort 2)

    Time frame: Day 1 to Day 13

  6. PK: AUC of LY4268989 (Cohort 2)

    Time frame: Day 1 to Day 13

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

    Time frame: Day 1 to Day 17

    PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989

  8. PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 8)

    Time frame: Day 3 and Day 11

    PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989

  9. PK: Cmax of Midazolam and 1'-Hydroxymidazolam (Cohort 3)

    Time frame: Day 1 to Day 17

    PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989

  10. PK: Cmax of Midazolam and 1'-Hydroxymidazolam (Cohort 8)

    Time frame: Day 3 to Day 11

    PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989

  11. PK: Cmax of LY4268989 (Cohort 6)

    Time frame: Day 1 to Day 7

  12. PK: AUC of LY4268989 (Cohort 6)

    Time frame: Day 1 to Day 7

  13. PK: Cmax of LY4268989 (Cohort 7)

    Time frame: Day 1 to Day 12

  14. PK: AUC of LY4268989 (Cohort 7)

    Time frame: Day 1 to Day 12

Secondary outcomes

  1. PK: Cmax of LY4268989 (Cohort 4)

    Time frame: Day 1 to Day 4

  2. PK: AUC of LY4268989 (Cohort 4)

    Time frame: Day 1 to Day 4

  3. PK: Cmax of LY4268989 (Cohort 3)

    Time frame: Time Frame: Day 6 to Day 15

  4. PK: AUC of LY4268989 (Cohort 3)

    Time frame: Time Frame: Day 6 to Day 15

  5. PK: Cmax of LY4268989 (Cohort 8)

    Time frame: Time Frame: Day 3 and Day 10

  6. PK: AUC of LY4268989 (Cohort 8)

    Time frame: Time Frame: Day 3 and Day 10

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 9, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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