Not provided
Not provided
Not provided
Not provided
Not provided
Withdrawn based on business decision, no participants enrolled
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPL-0301 Dose 1 | Experimental | Participants are randomized to OPL-0301 Dose 1 administered once daily for 90 days |
|
| OPL-0301 Dose 2 | Experimental | Participants are randomized to OPL-0301 Dose 2 administered once daily for 90 days |
|
| Placebo | Placebo Comparator | Participants are randomized to matching placebo administered once daily for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPL-0301 Dose 1 | Drug | Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infarct size as determined by cardiac magnetic resonance (CMR) at Day 90 | To evaluate the effects of OPL-0301 versus placebo on infarct size in adults with post-myocardial infarction left ventricular dysfunction at day 90 | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in infarct size by cardiac magnetic resonance (CMR) from initial CMR assessment to Day 90 | To evaluate the effects of OPL-0301 versus placebo on the change in infarct size in adults with post-myocardial infarction left ventricular dysfunction | Initial to 90 days |
| Adverse events (AEs) and Serious adverse events (SAEs) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Victor Shi, M.D. | Valo Health, Inc. | Study Director |
Not provided
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| D000072657 | ST Elevation Myocardial Infarction |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
This is a Phase 2, multicenter, randomized, placebo-controlled, multiple-arm, adaptive study investigating the safety, pharmacokinetics, and potential efficacy of OPL-0301, along with standard of care, in post-myocardial infarction (MI) participants with left ventricular dysfunction (LVD).
Participants will have been admitted to the hospital for acute MI and treated with primary percutaneous coronary intervention (PPCI) before entering the study. A fixed oral dose will be administered once daily, according to the blinded treatment assignment.
Not provided
Not provided
Not provided
| OPL-0301 Dose 2 | Drug | Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral |
|
| Placebo | Drug | Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral |
|
To assess the effects of OPL-0301 on safety and tolerability |
| Baseline to 120 days |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D018754 | Ventricular Dysfunction |