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

Valo Health

Status and phase: Withdrawn; Phase 2

Conditions: Myocardial Infarction

Treatments: Drug: OPL-0301 Dose 2; Drug: Placebo; Drug: OPL-0301 Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05327855

OPL-0301-201

Details and patient eligibility

About

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)

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are male or female between 18 and 90 years of age, inclusive, at the time of signing the informed consent
• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

OPL-0301 Dose 1

Experimental group

Description:

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

Treatment:

Drug: OPL-0301 Dose 1

OPL-0301 Dose 2

Experimental group

Description:

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

Treatment:

Drug: OPL-0301 Dose 2

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo