LY4005130 for Healthy Individuals

(FPAB Trial)

Not currently recruiting at 1 trial location

Overseen By Physicians interested in becoming principal investigators please contact

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how healthy individuals tolerate the new treatment LY4005130 and identify potential side effects. Participants will receive the treatment either as an injection under the skin or through a vein in the arm. The trial will measure how much of the drug enters the bloodstream and the time it takes for the body to eliminate it. This trial suits individuals who are healthy and have no recent surgeries, infections, or history of severe allergies. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the unique opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that LY4005130 is likely to be safe for humans?

Research has shown that LY4005130 is being tested to assess its tolerance in healthy individuals. The studies aim to identify any side effects that may occur when the drug is administered. As these are early-stage trials, the primary goal is to ensure LY4005130's safety for humans.

This is a Phase 1 trial, marking the first time LY4005130 is tested in humans. Although previous lab tests have been conducted, its safety in humans remains under evaluation. Participants will receive the drug either subcutaneously or intravenously, and researchers will closely monitor for any side effects. This phase helps determine safe dosage levels and identify immediate side effects.

No specific safety data from earlier trials exists, as this phase focuses on gathering initial safety information. However, by testing different doses systematically, researchers can quickly identify and manage any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about LY4005130 because it introduces a novel approach by potentially offering both subcutaneous (SC) and intravenous (IV) administration options, which could enhance flexibility and patient comfort compared to traditional treatments. Unlike many standard treatments that might take time to adjust or show effects, LY4005130 is being tested for its ability to provide results quickly with single-ascending or multiple-ascending doses. This adaptability in dosing and administration could represent a significant improvement in managing the condition, aiming for faster and more convenient efficacy.

What evidence suggests that LY4005130 could be effective?

Research on LY4005130 remains in the early stages, so limited information exists on its efficacy for specific conditions. This trial includes various treatment arms to assess LY4005130, focusing on its tolerability in healthy individuals and potential side effects. As the research primarily addresses safety rather than treatment, solid evidence on its effectiveness for any condition is not yet available. The aim is to understand how the body processes the drug, which is the first step in determining its potential for future treatments. ^{1 2 3 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06690996

A Study of LY4005130 in Healthy Participants The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in healthy participants.

2. app.trialscreen.org app.trialscreen.org/trials/phase-1-ly4005130-healthy-participants-trial-nct06690996

A Study of LY4005130 in Healthy Participants A Phase 1 study of LY4005130 in healthy participants. A study to evaluate the safety, tolerability, and pharmacokinetics of LY4005130 in healthy individuals.

3. clinconnect.io clinconnect.io/trials/NCT06690996

A Study of LY4005130 in Healthy Participants - ClinConnect The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in healthy participants.

4. withpower.com withpower.com/trial/ly4005130-for-healthy-individuals-5f634

LY4005130 for Healthy Individuals (FPAB Trial) The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in healthy participants.

5. sigma.larvol.com sigma.larvol.com/facility.php?e1=3517995&e2=&FacilityId=3517995&itype=0,1

Lilly Centre for Clinical Pharmacology Trials FPAB, NCT06690996: A Study of LY4005130 in Healthy Participants. Recruiting. 1 ... Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes) ...

6. policylab.us policylab.us/clinical-trials/l/texas/dallas?page=47

Dallas, TX Paid Clinical Trials - Policy Lab ... 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 ...

7. withpower.com withpower.com/t/paxil-cr

Paxil Cr: Everything you need to know | Power Paxil Cr explained. Explore Paxil Cr dosage, 100+ drug interactions, and generic alternatives. Compare Paxil Cr's side effects + efficacy.