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

February 16, 2023 updated by: Valo Health, Inc.

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)

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)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OPL-0301 Dose 1
Participants are randomized to OPL-0301 Dose 1 administered once daily for 90 days
Drug: OPL-0301 Dose 1
Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
Experimental: OPL-0301 Dose 2
Participants are randomized to OPL-0301 Dose 2 administered once daily for 90 days
Drug: OPL-0301 Dose 2
Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
Placebo Comparator: Placebo
Participants are randomized to matching placebo administered once daily for 90 days
Drug: Placebo
Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct size as determined by cardiac magnetic resonance (CMR) at Day 90
Time Frame: 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
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in infarct size by cardiac magnetic resonance (CMR) from initial CMR assessment to Day 90
Time Frame: 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
Initial to 90 days
Adverse events (AEs) and Serious adverse events (SAEs)
Time Frame: Baseline to 120 days
To assess the effects of OPL-0301 on safety and tolerability
Baseline to 120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valo Health, Inc.

Investigators

  • Study Director: Victor Shi, M.D., Valo Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPL-0301-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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