Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)

(RESTORE Trial)

Overseen By Courtney Ewert

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Valo Health, Inc.

Must not be taking: S1P modulators

Disqualifiers: Previous MI, PCI, CABG, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment for people with heart problems after a heart attack. It aims to reduce heart damage and improve heart function.

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

The trial requires that you stop taking Sphingosine-1 Phosphate (S1P) modulators, which include medications like fingolimod, siponimod, ozanimod, and ponesimod. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

Research Team

Victor Shi, M.D.

Principal Investigator

Valo Health, Inc.

Eligibility Criteria

Inclusion Criteria

Are hospitalized with acute ST-Elevated Myocardial Infarction (STEMI), defined based on American Heart Association (AHA)/American College of Cardiology (ACC) criteria

Have cardiac troponin-I (cTnI), cardiac troponin-T (cTnT) levels ≥10x upper limit of normal (ULN) at least once during the index event of myocardial infarction

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OPL-0301 or placebo once daily for 90 days

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• OPL-0301
• Placebo

Participant Groups

Group I: OPL-0301 Dose 2 Experimental Treatment 1 Intervention

Participants are randomized to OPL-0301 Dose 2 administered once daily for 90 days

Group II: OPL-0301 Dose 1 Experimental Treatment 1 Intervention

Participants are randomized to OPL-0301 Dose 1 administered once daily for 90 days

Group III: Placebo Placebo Group 1 Intervention

Participants are randomized to matching placebo administered once daily for 90 days

Who Is Running the Clinical Trial?

Valo Health, Inc.

Lead Sponsor

Trials

2

Recruited

110+