LY4268989 for Healthy Subjects

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Prescription medications

Disqualifiers: Infections, Uncontrolled disorders, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 17 days

66 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current medications, including dietary supplements and herbal remedies, at least 14 days before the study starts, unless the study team decides they won't interfere with the trial.

What is the purpose of this trial?

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

Research Team

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)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for healthy individuals, including those of Japanese and Chinese descent. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or pose a risk.

Inclusion Criteria

Cohort 5 includes Japanese participants who 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 born in Japan

Have a body mass index within the range of 18.0 to 32.0 kilogram/square meter (kilogram/m²), inclusive, at screening

I am healthy based on recent medical exams and tests.

Exclusion Criteria

Are immunocompromised to an extent that participation in the study would pose an unacceptable risk

I have used or plan to use medication or supplements within 14 days before starting the trial.

I haven't had symptoms or signs of an infection for at least 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4268989 or placebo in various cohorts, including single and multiple doses, with some cohorts involving midazolam administration

Up to 17 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of TEAEs and SAEs

4 weeks

Treatment Details

Interventions

• LY4268989

Trial Overview The study is testing LY4268989 (MORF-057), comparing it to a placebo and Midazolam. It aims to understand how LY4268989 is absorbed, processed by the body, its effects on the body, as well as its safety and tolerability in healthy people.

Participant Groups

Group I: LY4268989 or Placebo Cohort 4 (Blinded) Experimental Treatment 2 Interventions

Participants will receive single escalating doses of LY4268989 orally or placebo

Group II: LY4268989 or Placebo Cohort 1 (Blinded) Experimental Treatment 2 Interventions

Participants will receive LY4268989 orally or placebo single dose followed by BID administration

Group III: LY4268989 Cohort 5 (Blinded) Experimental Treatment 2 Interventions

Participants will receive multiple doses of LY4268989 orally or placebo

Group IV: LY4268989 Cohort 3 (Open-Label) Experimental Treatment 2 Interventions

Participants will receive multiple doses of LY4268989 orally BID administration with midazolam orally and intravenously (IV).

Group V: LY4268989 Cohort 2 (Open-Label) Experimental Treatment 1 Intervention

Participants will receive LY4268989 orally tablet (formulation compared to capsule formulation) in a fasted state

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University