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

Last updated: February 16, 2023
Sponsor: Valo Health, Inc.
Overall Status: Trial Not Available

Phase

2

Condition

Heart Defect

Cardiovascular Disease

Coronary Artery Disease

Treatment

N/A

Clinical Study ID

NCT05327855
OPL-0301-201
  • Ages 18-90
  • All Genders

Study Summary

Study OPL-0301-201 is intended to generate efficacy and safety data of OPL-0301 in participants with post-myocardial infarction (MI) left ventricular dysfunction (LVD)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Are male or female between 18 and 90 years of age, inclusive, at the time of signingthe informed consent
  • Are hospitalized with acute ST-Elevated Myocardial Infarction (STEMI), defined basedon American Heart Association (AHA)/American College of Cardiology (ACC) criteria
  • Have cardiac troponin-I (cTnI), cardiac troponin-T (cTnT) levels ≥10x upper limit ofnormal (ULN) at least once during the index event of myocardial infarction

Exclusion

Exclusion Criteria:

  • Previous history of documented myocardial infarction
  • Previous history of percutaneous coronary intervention (PCI) within 6 months orcoronary artery bypass graft surgery (CABG) or valvular heart surgery at any timeprior to screening
  • Previous history of documented chronic left ventricular dysfunction with ejectionfraction (EF) < 50%
  • Previous history of decompensated heart failure
  • Previous history of documented specific cardiomyopathy (including but not limited tohypertrophic cardiomyopathy (HCM), amyloid, sarcoid, etc.)
  • Previous history of documented arrhythmias
  • Are being treated with Sphingosine-1 Phosphate (S1P) modulators (fingolimod,siponimod, ozanimod, ponesimod)

Study Design

Study Start date:
September 01, 2022
Estimated Completion Date:
November 30, 2024

Study Description

OPL-0301 is intended to address the disease state of post-myocardial infarction (MI) left ventricular dysfunction (LVD). MI is a manifestation of atherosclerotic coronary artery disease, the pathogenesis of which is closely associated with vascular and endothelial dysfunction, and inflammation. Acute MI leads to acute LVD, which often persists, leading to poor cardiovascular outcomes. The therapeutic hypothesis is that these effects mediated by Sphingosine-1 Phosphate 1 (S1P1) receptor agonism with OPL-0301 will reduce infarct size and benefit post-MI left ventricular function, thereby supporting improved cardiovascular outcomes in this patient population.

Connect with a study center

  • Site 1

    Gainesville, Georgia 30501
    United States

    Site Not Available

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