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

Phase 2

Withdrawn

• Conditions: Myocardial Infarction
• Interventions: Drug: OPL-0301 Dose 1; Drug: OPL-0301 Dose 2; Drug: Placebo

• Registration Number: NCT05327855
• Lead Sponsor: Valo Health, Inc.

Brief 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)

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-14
• Study Start: 2022-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21
• Primary Completion: 2024-08
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPL-0301 Dose 1	OPL-0301 Dose 1	Participants are randomized to OPL-0301 Dose 1 administered once daily for 90 days
OPL-0301 Dose 2	OPL-0301 Dose 2	Participants are randomized to OPL-0301 Dose 2 administered once daily for 90 days
Placebo	Placebo	Participants are randomized to matching placebo administered once daily for 90 days

Primary Outcome Measures

Name	Time	Method
Infarct size as determined by cardiac magnetic resonance (CMR) at Day 90	90 days	To evaluate the effects of OPL-0301 versus placebo on infarct size in adults with post-myocardial infarction left ventricular dysfunction at day 90

Secondary Outcome Measures

Name	Time	Method
Adverse events (AEs) and Serious adverse events (SAEs)	Baseline to 120 days	To assess the effects of OPL-0301 on safety and tolerability
Change in infarct size by cardiac magnetic resonance (CMR) from initial CMR assessment to Day 90	Initial to 90 days	To evaluate the effects of OPL-0301 versus placebo on the change in infarct size in adults with post-myocardial infarction left ventricular dysfunction