Testing LY4268989 in healthy participants
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
This study is testing a new drug called LY4268989 in healthy people to see how their bodies handle it and if there are any differences based on ethnicity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 1 site (Anaheim, California) |
| Trial ID | NCT06964776 on ClinicalTrials.gov |
What this trial studies
This study evaluates the absorption, processing, safety, and tolerability of the drug LY4268989 (MORF-057) in healthy individuals. It includes specific cohorts of Japanese and Chinese participants to assess any differences in drug response based on ethnicity. Participants will receive either the study drug or a placebo, and their health will be monitored through various medical evaluations. The study aims to gather important data on how the body reacts to this new medication.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 18-65 with a body mass index between 18.0 and 32.0, including first-generation Japanese and Chinese participants.
Not a fit: Patients with current or recent infections or those outside the specified BMI range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of LY4268989, potentially leading to new treatment options.
How similar studies have performed: While this study focuses on a specific drug and population, similar studies have shown success in understanding drug metabolism and safety in healthy cohorts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Anaheim, California
- CenExel ACT — Anaheim, California, United States (Recruiting)
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.