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

Phase 2
Waitlist Available
Research Sponsored by Valo Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 120 days

Summary

This trial is testing a new treatment for people with heart problems after a heart attack. It aims to reduce heart damage and improve heart function.

Eligible Conditions
  • Heart Attack

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 120 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 120 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Infarct size as determined by cardiac magnetic resonance (CMR) at Day 90
Secondary study objectives
Adverse events (AEs) and Serious adverse events (SAEs)
Change in infarct size by cardiac magnetic resonance (CMR) from initial CMR assessment to Day 90

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: OPL-0301 Dose 2Experimental Treatment1 Intervention
Participants are randomized to OPL-0301 Dose 2 administered once daily for 90 days
Group II: OPL-0301 Dose 1Experimental Treatment1 Intervention
Participants are randomized to OPL-0301 Dose 1 administered once daily for 90 days
Group III: PlaceboPlacebo Group1 Intervention
Participants are randomized to matching placebo administered once daily for 90 days

Find a Location

Who is running the clinical trial?

Valo Health, Inc.Lead Sponsor
1 Previous Clinical Trials
114 Total Patients Enrolled
Victor Shi, M.D.Study DirectorValo Health, Inc.
1 Previous Clinical Trials
114 Total Patients Enrolled
Philip D Yin, M.D., Ph.D.Study DirectorValo Health, Inc.
Philip D Lin, M.D., Ph.D.Study DirectorValo Health, Inc.
~0 spots leftby Dec 2025
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