LY3462817 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

Disqualifiers: Cancer, Malignant disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the safety and tolerability of a new treatment called LY3462817 in healthy volunteers. Researchers seek to determine how quickly the drug enters the bloodstream and how long the body takes to eliminate it. Participants will receive either LY3462817 or a placebo (a substance with no active drug) through injections or intravenous (IV) methods. Suitable candidates are healthy individuals, either Japanese or non-Japanese, who are comfortable with receiving injections or IV treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that taking medications could affect eligibility.

Is there any evidence suggesting that LY3462817 is likely to be safe for humans?

Research has shown that LY3462817 has undergone safety testing in several studies. Researchers administered it both intravenously (IV) and subcutaneously (SC) to healthy individuals. These studies aimed to assess how well participants tolerate the drug and identify any side effects.

In earlier studies, LY3462817 was also tested in individuals with conditions like psoriasis and rheumatoid arthritis, focusing on safety and tolerability. No serious safety issues emerged in these studies.

The current trial is an early-phase study, primarily ensuring the treatment's safety before progressing to larger studies. The previous testing of LY3462817 in other conditions suggests a positive safety profile. However, as this is an early-phase trial, researchers continue to monitor the treatment closely to confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about LY3462817 because it offers a novel approach to treatment. Unlike existing options that typically rely on specific pathways or mechanisms, LY3462817 is being tested both subcutaneously (SC) and intravenously (IV), giving it versatility in administration. This flexibility could potentially enhance patient compliance and convenience. Moreover, its unique formulation might target different biological pathways, providing hope for improved effectiveness or reduced side effects compared to standard treatments.

What evidence suggests that LY3462817 could be effective?

Research has shown that LY3462817, also known as peresolimab, may help treat rheumatoid arthritis. In studies, this treatment significantly reduced joint swelling in people with moderate to severe rheumatoid arthritis. Participants in this trial will receive either LY3462817 or a placebo. One study found that patients who received LY3462817 experienced a clear reduction in symptoms compared to those who received a placebo. These results suggest that LY3462817 could effectively manage rheumatoid arthritis symptoms by reducing joint swelling. Although the treatment is still under study, early results are promising. ^{6 7 8 9 10}

Who Is on the 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

Are You a Good Fit for This Trial?

Inclusion Criteria

You are a non-Japanese participant.

You are of childbearing potential.

You have the necessary medical and psychological conditions for the study.

Exclusion Criteria

Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study

Have previously participated or withdrawn from this study

Have cancer or a malignant disease in the past 5 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3462817 or placebo, administered subcutaneously or intravenously

12 weeks

Multiple visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3462817

How Is the Trial Designed?

Group I: LY3462817 - SC Experimental Treatment 1 Intervention

LY3462817 administered subcutaneously (SC)

Group II: LY3462817 - IV Experimental Treatment 1 Intervention

LY3462817 administered intravenously (IV)

Group III: Placebo - IV Placebo Group 1 Intervention

Placebo administered IV

Group IV: Placebo - SC Placebo Group 1 Intervention

Placebo administered SC

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/NCT04634253

NCT04634253 | A Study of LY3462817 in Participants With ... In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04634253?cond=Rheumatoid%20Arthritis

A Study of LY3462817 in Participants With Rheumatoid ... In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical ...

3. firstwordpharma.com firstwordpharma.com/story/5741732

Lilly's peresolimab hits main goal in Phase II rheumatoid ... The study randomised 98 adults with moderate-to-severe RA to receive an intravenous infusion of peresolimab or placebo once every four weeks.

4. the-rheumatologist.org the-rheumatologist.org/article/peresolimab-promising-for-ra/

Peresolimab Promising for RA This randomized clinical trial (NCT04634253) evaluated the safety and efficacy of peresolimab for treating adults with moderate to severe active rheumatoid ...

5. trial.medpath.com trial.medpath.com/clinical-trial/1ba9cf26dd1e4002/euctr2020-002673-10-hu-ly3462817-efficacy-safety-rheumatoid-arthritis

A Phase 2 Study to Evaluate the Efficacy and Safety of ... A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants with Moderately to Severely Active Rheumatoid Arthritis ... Outcome data and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03715192

A Safety Study of LY3462817 in Healthy Participants This study is being conducted to determine how safe and how well tolerated LY3462817 is when given intravenously (IV) (into a vein) and subcutaneously (SC) ( ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05440136

A Safety Study of LY3462817 in Healthy Japanese and ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

8. file.medchemexpress.com file.medchemexpress.com/batch_PDF/HY-P9993/Peresolimab-SDS-MedChemExpress.pdf

Safety Data Sheet Ensure adequate ventilation. Provide accessible safety shower and eye wash station. Personal protective equipment. Eye protection. Safety ...

9. ctv.veeva.com ctv.veeva.com/study/a-safety-study-of-ly3462817-and-ly3509754-in-participants-with-psoriasis

A Safety Study of LY3462817 and LY3509754 in Participants ... This study is being conducted to determine how safe and how well tolerated LY3462817 is when given to participants with psoriasis.

10. trials.arthritis.org trials.arthritis.org/trials/NCT04634253

A Study of LY3462817 in Participants With Rheumatoid Arthritis The reason for this study is to see if the study drug LY3462817 is safe and effective in participants with moderately to severely active rheumatoid arthritis ( ...