LY4005130 for Healthy Individuals

(FPAB Trial)

Recruiting at 1 trial location

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

Disqualifiers: Childbearing potential, Allergies, Malignant disease, others

Compensation: Varies

Number of Visits: 21

140 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy individuals, it's likely that participants should not be on any regular medications. Please consult with the trial coordinator for specific guidance.

What is the purpose of this trial?

The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4005130 gets into the bloodstream and how long it takes the body to eliminate it. Part A for the single-ascending doses (SAD) of the study will last about 12 weeks with 9 visits. Part B for the multiple-ascending doses (MAD) of the study will either last about 16 weeks with 13 visits or 20 weeks with 12 visits not counting the time for screening.

Research Team

Contact Lilly at 1-800-LillyRx (1-800-545-5979)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for healthy individuals who are willing to receive a new drug, LY4005130, either under the skin or into a vein. The study will involve multiple visits over 12 to 20 weeks. Specific eligibility criteria details were not provided.

Inclusion Criteria

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

If enrolled as Japanese or Chinese, specific ancestry requirements apply

I weigh at least 45 kg and my BMI is between 18 and 32.

Exclusion Criteria

I have not had recent surgery.

Individuals of childbearing potential are excluded

Known allergies to LY4005130, related compounds, or any components of the formulation are exclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single-ascending Dose (SAD)

Participants receive single-ascending doses of LY4005130 administered subcutaneously or intravenously

12 weeks

9 visits

Multiple-ascending Dose (MAD)

Participants receive multiple-ascending doses of LY4005130 administered subcutaneously or intravenously

16-20 weeks

12-13 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY4005130

Trial Overview The study is testing the tolerability of LY4005130 in healthy participants and monitoring side effects. It includes two parts: one where single doses are given (SAD) and another with multiple doses (MAD). Blood tests will track how the body processes the drug.

Participant Groups

Group I: LY4005130 Part B (MAD) SC or IV Experimental Treatment 1 Intervention

Multiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts

Group II: LY4005130 Part B (MAD) Optional Experimental Treatment 1 Intervention

Multiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts

Group III: LY4005130 Part B (MAD) IV Experimental Treatment 1 Intervention

Multiple-ascending doses of LY4005130 administered IV

Group IV: LY4005130 Part A (SAD) SC Experimental Treatment 1 Intervention

A single-ascending dose of LY4005130 administered subcutaneously (SC)

Group V: LY4005130 Part A (SAD) Optional Experimental Treatment 1 Intervention

A single-ascending dose of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts

Group VI: LY4005130 Part A (SAD) IV Experimental Treatment 1 Intervention

A single-ascending dose of LY4005130 administered intravenously (IV)

Group VII: Placebo Part B (MAD) IV Placebo Group 1 Intervention

Placebo administered IV

Group VIII: Placebo Part A (SAD) SC Placebo Group 1 Intervention

Placebo administered SC

Group IX: Placebo Part A (SAD) Optional Placebo Group 1 Intervention

A single-ascending dose of placebo administered either SC or IV depending on emerging data from earlier cohorts

Group X: Placebo Part A (SAD) IV Placebo Group 1 Intervention

Placebo administered IV

Group XI: Placebo Part B (MAD) SC or IV Placebo Group 1 Intervention

Multiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts

Group XII: Placebo Part B (MAD) Optional Placebo Group 1 Intervention

Multiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts

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