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

NCT05327855 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: OPL-0301-201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Myocardial Infarction

Keywords

heart attack; acute ischemic heart disease; acute coronary syndrome; ST-Elevated Myocardial Infarction; left ventricular dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in infarct size by cardiac magnetic resonance (CMR) from initial CMR assessment to Day 90

  Initial to 90 days

• Adverse events (AEs) and Serious adverse events (SAEs)

  Baseline to 120 days

Study Arms (3)

OPL-0301 Dose 1

EXPERIMENTAL

Participants are randomized to OPL-0301 Dose 1 administered once daily for 90 days

Drug: OPL-0301 Dose 1

OPL-0301 Dose 2

EXPERIMENTAL

Participants are randomized to OPL-0301 Dose 2 administered once daily for 90 days

Drug: OPL-0301 Dose 2

Placebo

PLACEBO COMPARATOR

Participants are randomized to matching placebo administered once daily for 90 days

Drug: Placebo

Interventions

OPL-0301 Dose 1 DRUG

Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral

OPL-0301 Dose 1

OPL-0301 Dose 2 DRUG

Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral

OPL-0301 Dose 2

Placebo DRUG

Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Valo Health, Inc.: lead

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Ventricular Dysfunction

Study Officials

• Victor Shi, M.D.

  Valo Health, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: April 14, 2022
• Study Start: September 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-02