MYK-224 for Hypertrophic Cardiomyopathy

(MERCUTIO Trial)

Recruiting at 42 trial locations

Overseen By First line of the email MUST contain the NCT# and Site #.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to characterize the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MYK-224 in participants with obstructive Hypertrophic Cardiomyopathy (oHCM)

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for men and women with obstructive Hypertrophic Cardiomyopathy (oHCM) who have symptoms, a thickened heart wall, and specific heart function criteria. They must be able to undergo exercise stress testing and not have had certain recent cardiac procedures or treatments.

Inclusion Criteria

I experience mild to moderate heart symptoms.

I have been diagnosed with obstructive hypertrophic cardiomyopathy according to current guidelines.

My heart screening showed a specific high pressure reading.

Exclusion Criteria

I have been treated with heart-damaging drugs like doxorubicin.

I have had or will have an ICD placed or changed recently.

I have had heart issues with reduced pumping efficiency.

Treatment Details

Interventions

• MYK-224 (Unknown)

Trial Overview The study tests MYK-224's effects on people with oHCM. It aims to understand how safe it is, how well it works, what the body does to the drug (pharmacokinetics), and how the drug affects the body (pharmacodynamics).

Participant Groups

Group I: Cohort 2 Experimental Treatment 1 Intervention

Participants will receive MYK-224 in combination with standard-of-care consisting of either a calcium channel blocker or disopyramide (which is given in combination with either a beta-blocker or calcium channel blocker). Participants who complete Cohort 2 will be eligible for an optional open label extension period

Group II: Cohort 1 Experimental Treatment 1 Intervention

Participants will receive MYK-224 either as a monotherapy or in combination with standard-of-care consisting of a beta-blocker. Participants who complete Cohort 1 will be eligible for an optional open label extension period

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania