Clinical trial NCT06964776: A Study of LY4268989 (MORF-057) in Healthy Participants
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-05-09
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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


Eligibility criteria: 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 (kilogram/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

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 (Cohort 1) and (Cohort 5)
timeFrame: Day 1 to Day 17
measure: PK: Area Under the Concentration Curve (AUC) of LY4268989 (Cohort 1) and (Cohort 5)
timeFrame: Day 1 to Day 17
measure: 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)
measure: Number of Participants with TEAEs and SAEs (Cohort 4)
timeFrame: Baseline to Study Completion (Up to Period 4, Day 4)
measure: PK: Cmax of LY4268989 (Cohort 2)
timeFrame: Day 1 to Day 13
measure: PK: AUC of LY4268989 (Cohort 2)
timeFrame: Day 1 to Day 13
measure: PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 3)
timeFrame: Day 1 to Day 17]
measure: PK: Cmax of Midazolam and 1'-Hydroxymidazolam (Cohort 3)
timeFrame: Day 1 to Day 17
Secondary outcomes:
measure: PK: Cmax of LY4268989 (Cohort 4)
timeFrame: Day 1 to Day 4
measure: PK: AUC of LY4268989 (Cohort 4)
timeFrame: Day 1 to Day 4
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: CenExel ACT
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: