OPL-0301 for Heart Attack
(RESTORE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called OPL-0301 for individuals who have experienced a heart attack and now face issues with heart function. The goal is to determine if OPL-0301 is safe and effective compared to a placebo (a pill with no active medicine). Participants will receive one of two OPL-0301 doses or a placebo for 90 days. This trial may suit someone currently hospitalized due to a recent severe heart attack, with significantly elevated heart enzyme levels. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial requires that you stop taking Sphingosine-1 Phosphate (S1P) modulators, which include medications like fingolimod, siponimod, ozanimod, and ponesimod. For other medications, the protocol does not specify, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that OPL-0301 is being tested for safety and effectiveness in people with heart issues after a heart attack. Although detailed safety information from earlier studies is not available, this treatment has entered a Phase 2 trial, indicating it passed initial safety tests in earlier trials.
Phase 2 trials assess a treatment's safety and effectiveness. At this stage, a treatment is generally considered safe enough for more participants, though some risks may still exist. Since no specific safety problems have been reported in the available sources, OPL-0301 appears well-tolerated so far. However, any new treatment can have side effects, so it's important to consider this when deciding to join a trial.12345Why do researchers think this study treatment might be promising?
Researchers are excited about OPL-0301 because it offers a new approach for treating patients after a heart attack, or myocardial infarction. Unlike standard treatments like beta-blockers or ACE inhibitors, which primarily manage symptoms and prevent further heart damage, OPL-0301 may work by a different mechanism, possibly targeting underlying pathways involved in heart recovery. This could potentially enhance heart healing and improve long-term outcomes for patients. The trial is exploring two different doses, which might help determine the most effective way to utilize this promising new treatment.
What evidence suggests that OPL-0301 might be an effective treatment for post-MI left ventricular dysfunction?
Research has shown that OPL-0301 might aid heart attack patients by enhancing heart function and reducing heart damage. This trial will test various doses of OPL-0301, focusing on its effects on the S1P1 receptor, believed to protect the heart. Early results suggest that OPL-0301 could lead to less heart damage and improved heart function. Although further studies are necessary, this approach appears promising for those with heart issues following a heart attack.12467
Who Is on the Research Team?
Victor Shi, M.D.
Principal Investigator
Valo Health, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive OPL-0301 or placebo once daily for 90 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- OPL-0301
- Placebo
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants are randomized to OPL-0301 Dose 2 administered once daily for 90 days
Participants are randomized to OPL-0301 Dose 1 administered once daily for 90 days
Participants are randomized to matching placebo administered once daily for 90 days
Find a Clinic Near You
Who Is Running the Clinical Trial?
Valo Health, Inc.
Lead Sponsor
Citations
Efficacy and Safety of OPL-0301 Compared to Placebo in ...
The therapeutic hypothesis is that these effects mediated by Sphingosine-1 Phosphate 1 (S1P1) receptor agonism with OPL-0301 will reduce infarct size and ...
2.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05327855/efficacy-and-safety-of-opl-0301-compared-to-placebo-in-adults-with-post-myocardial-infarction-miEfficacy and Safety of OPL-0301 Compared to Placebo in ...
Study OPL-0301-201 is intended to generate efficacy and safety data of OPL-0301 in participants with post-myocardial infarction (MI) left ...
OPL-0301 - Drug Targets, Indications, Patents
Opal's AI algorithms are also applied to patient data, analysis of which can identify patterns in drug response, which in turn can help identify patient ...
Efficacy and Safety of OPL-0301 Compared to Placebo in ...
This trial tests OPL-0301 vs placebo to reduce heart damage and improve function after a heart attack, with 90 days of treatment and 12 weeks follow-up.
Trial | NCT05327855
OPL-0301 is intended to address the disease state of post-myocardial infarction (MI) left ventricular dysfunction (LVD). MI is a manifestation of ...
OPL-0301-201 - GoodDay - Xogene
Study OPL-0301-201 is intended to generate efficacy and safety data of OPL-0301 in participants with post-myocardial infarction (MI) left ventricular ...
OPL-0301 / Sanofi, Valo Health
S1PR1-biased activation drives the resolution of endothelial dysfunction-associated inflammatory diseases by maintaining endothelial integrity.
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