Mavacamten for Hypertrophic Cardiomyopathy

(ODYSSEY-HCM Trial)

Recruiting at 502 trial locations

Overseen By Thomas McDonald, Site 0281

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bristol-Myers Squibb

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 9 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called mavacamten to see if it is safe and effective for people with a heart condition that makes their heart muscle too thick. The goal is to help their heart work better and improve their symptoms.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for people with a heart condition called non-obstructive hypertrophic cardiomyopathy (nHCM). Participants should have significant thickening of the heart muscle, experience symptoms, and fall under specific classifications of heart function. They can't join if they've had unexplained fainting or dangerous irregular heartbeats recently, or if their condition might be due to another disease.

Inclusion Criteria

Unexplained left-ventricular hypertrophy with non-dilated ventricular chambers

My heart's wall is thicker than normal, or it's slightly less thick but with a family history of HCM.

My heart condition mildly or moderately affects my daily activities.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

History of unexplained syncope within 6 months prior to screening

I have had a fast heart rate that lasted more than 30 seconds in the last 6 months.

Treatment Details

Interventions

• Mavacamten (Myosin Inhibitor)
• Placebo (Other)

Trial Overview The study is testing Mavacamten against a placebo to see if it's safe and effective for nHCM. Patients will randomly receive either the actual medication or a placebo without knowing which one they are taking.

Participant Groups

Group I: Mavacamten Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Mavacamten is already approved in Canada, Switzerland, Brazil for the following indications:

Approved in Canada as Camzyos for:

• Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)

Approved in Switzerland as Camzyos for:

• Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)

Approved in Brazil as Camzyos for:

• Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)

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