580 Participants Needed

Mavacamten for Hypertrophic Cardiomyopathy

(ODYSSEY-HCM Trial)

Recruiting at 502 trial locations
BS
Fl
TM
Overseen ByThomas McDonald, Site 0281
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Bristol-Myers Squibb
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 9 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the drug Mavacamten for treating hypertrophic cardiomyopathy?

Research shows that Mavacamten, a drug approved by the FDA, improves symptoms and exercise capacity in patients with obstructive hypertrophic cardiomyopathy by reducing heart muscle obstruction. Clinical trials found it more effective than a placebo in improving heart function and reducing the need for surgical interventions.12345

Is mavacamten safe for humans?

Mavacamten, also known as Camzyos or MYK-461, has been studied in clinical trials for hypertrophic cardiomyopathy and was generally well tolerated, with some patients experiencing serious adverse events. It was approved by the FDA in April 2022, indicating that its benefits outweigh the risks for this condition, but full safety information is available on the FDA's website.23467

What makes the drug Mavacamten unique for treating hypertrophic cardiomyopathy?

Mavacamten is unique because it is a first-of-its-kind drug that directly targets the heart's muscle fibers by inhibiting myosin, which helps reduce the excessive contraction of the heart muscle seen in hypertrophic cardiomyopathy. Unlike other treatments that mainly address symptoms, Mavacamten works at the root cause by modulating the heart's muscle function.12689

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

BS

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.
See 2 more

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.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mavacamten or placebo to evaluate safety, tolerability, and efficacy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Mavacamten
  • Placebo
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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MavacamtenExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Mavacamten is already approved in United States, European Union, Canada, Switzerland, Brazil for the following indications:

🇺🇸
Approved in United States as Camzyos for:
  • Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
🇪🇺
Approved in European Union as Camzyos for:
  • Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
🇨🇦
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)

Find a Clinic Near You

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 profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

Findings from Research

Mavacamten effectively reduces left ventricular outflow obstruction and improves heart function in patients with obstructive hypertrophic cardiomyopathy, offering a new treatment option for those who do not respond to standard therapies.
Despite its efficacy, mavacamten is not considered cost-effective, with a high acquisition cost leading to significant expenses for additional quality-adjusted life years, and its role in treating nonobstructive hypertrophic cardiomyopathy remains unclear.
Mavacamten, a First-in-Class Cardiac Myosin Inhibitor for Obstructive Hypertrophic Cardiomyopathy.Dalo, JD., Weisman, ND., White, CM.[2023]
Mavacamten (Camzyos) is a newly approved treatment for obstructive hypertrophic cardiomyopathy (HCM) that works by selectively inhibiting myosin, a key protein in the heart's muscle cells, to improve heart function directly at the sarcomere level.
This treatment addresses the underlying causes of HCM, unlike current options that mainly provide symptomatic relief, potentially leading to better outcomes for patients with this condition.
Mavacamten, a precision medicine for hypertrophic cardiomyopathy: From a motor protein to patients.Nag, S., Gollapudi, SK., Del Rio, CL., et al.[2023]
Mavacamten is a targeted cardiac-specific myosin inhibitor approved for treating adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), showing significant efficacy in reducing left ventricular outflow tract gradients and improving exercise capacity in Phase 2 and 3 clinical trials.
The treatment was well tolerated and led to favorable cardiac remodeling, reducing the need for invasive septal reduction therapy in patients with drug-refractory symptoms, indicating its potential as a key option in managing oHCM.
Mavacamten: a first-in-class myosin inhibitor for obstructive hypertrophic cardiomyopathy.Braunwald, E., Saberi, S., Abraham, TP., et al.[2023]

References

Mavacamten, a First-in-Class Cardiac Myosin Inhibitor for Obstructive Hypertrophic Cardiomyopathy. [2023]
Mavacamten, a precision medicine for hypertrophic cardiomyopathy: From a motor protein to patients. [2023]
Mavacamten: a first-in-class myosin inhibitor for obstructive hypertrophic cardiomyopathy. [2023]
Mavacamten Treatment for Hypertrophic Cardiomyopathy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]
Effect of Mavacamten on Echocardiographic Features in Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy. [2022]
Mavacamten: First Approval. [2022]
Safety and efficacy of mavacamten for treatment of hypertrophic cardiomyopathy: a systematic review and meta-analysis of randomized clinical trials. [2023]
Mavacamten: a novel small molecule modulator of β-cardiac myosin for treatment of hypertrophic cardiomyopathy. [2022]
Mavacamten, an Alternative to Septal Reduction Therapy for Patients with Hypertrophic Cardiomyopathy. [2023]
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