LY4515100 for Healthy Participants

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: Over-the-counter, Prescription, Dietary, Herbal

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

Compensation: Varies

Number of Visits: 6

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to 30 days and will include six overnight stays.

Who Is on the Research Team?

Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy individuals with a BMI of 18.5 to 32.0 kg/m^2 who are not able to have children. Participants must pass medical evaluations including history, physical exams, lab tests, vital signs, and heart monitoring.

Inclusion Criteria

I am not capable of becoming pregnant.

I am not capable of becoming pregnant.

I am generally healthy based on recent medical exams and tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive single- and multiple-ascending doses of LY4515100 or placebo

30 days

6 overnight stays

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY4515100

Trial Overview

The study is testing the safety and effects of LY4515100 when taken orally by healthy people. It involves blood tests to see how the body handles the drug and its impact on participants over up to 30 days with six overnight stays.

How Is the Trial Designed?

Group I: LY4515100 of Part B (MAD) Experimental Treatment 1 Intervention

Multiple-ascending doses of LY4515100 will be given orally

Group II: LY4515100 of Part A (SAD) Experimental Treatment 1 Intervention

Single-ascending doses of LY4515100 will be given orally

Group III: Placebo Part A Placebo Group 1 Intervention

Placebo will be given orally

Group IV: Placebo Part B Placebo Group 1 Intervention

Placebo will be given orally

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