NCT05327855

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

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple-arm, Parallel-group, Adaptive Study to Investigate the Efficacy and Safety of OPL-0301 in Patients With Post-myocardial Infarction Left Ventricular Dysfunction (RESTORE)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Valo Health, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	OPL-0301 Dose 1	Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
DRUG	OPL-0301 Dose 2	Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
DRUG	Placebo	Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-08-01
• Completion: 2024-11-01
• First posted: 2022-04-14
• Last updated: 2023-02-21

Regulatory

• FDA-regulated drug study