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Heart drug trial halted early: MYK-224 studied for thick heart muscle

NCT ID NCT05556343

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called MYK-224 in 18 adults with a type of heart disease that makes the heart muscle too thick and blocks blood flow. The goal was to see if the drug is safe and helps reduce symptoms. The trial was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

18 people

The number who actually took part.

Started

Jan 2023

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has adequate acoustic windows, to enable accurate TTEs as determined by the echocardiography core laboratory. * Men or women diagnosed with oHCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines, satisfying both of the following criteria: * Has unexplained left ventricular (LV) hypertrophy with nondilated ventricular chambers in the absence of other cardiac (eg, hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 millimeter (mm) (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy or with a known disease-causing mutation), as determined by core laboratory interpretation. AND \-- Has a LVOT peak gradient during screening as assessed by echocardiography of ≥ 50 millimeters of mercury (mm Hg) at rest, or ≥ 30 mm Hg at rest and ≥ 50 mm Hg with Valsalva maneuver (confirmed by echocardiography core laboratory interpretation). * Has resting LVEF ≥ 60% at the Screening visit as determined by echocardiography core laboratory. * New York Heart Association (NYHA) functional class II or III symptoms at screening. * Has a valid measurement of LVOT post-exercise peak gradient at screening as determined by echocardiography core laboratory. Exclusion Criteria: * Presence of any medical condition that precludes exercise stress testing. * History of syncope or sustained ventricular tachyarrhythmia within 6 months prior to screening. * Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with left ventricular hypertrophy. * Prior treatment with mavacamten or aficamten. An exception may be made in cases where myosin inhibitor use was not within 4 months of the Screening visit, and with the agreement of both the Investigator and the Medical Monitor. * Has been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\]) within 6 months prior to Screening or plans to have either of these treatments during the study (Note: Individuals with an unsuccessful myectomy or percutaneous ASA procedure performed \> 6 months prior to Screening may be enrolled if study eligibility criteria for LVOT gradient criteria are met). * Implantable cardioverter-defibrillator (ICD) placement or pulse generator change within 2 months prior to screening or planned new ICD placement during the study (pulse generator changes, if needed during the study are allowed). * Has a history of resuscitated sudden cardiac arrest (any time) or known history of appropriate implantable cardioverter-defibrillator (ICD discharge for life-threatening ventricular arrhythmia within 6 months prior to screening. * Has paroxysmal, atrial fibrillation with atrial fibrillation present per the Investigator's evaluation of the participant's ECG at the time of Screening. * Has persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate controlled within 6 months prior to Screening (Note: Participants with persistent or permanent atrial fibrillation who are anticoagulated and adequately rate-controlled are allowed). * Has QT interval with Fridericia correction (QTcF) \> 500 msec when QRS interval \< 120 msec or QTcF \> 520 msec when QRS ≥ 120 msec if participant has left bundle branch block or any other 12-lead ECG abnormality considered by the investigator to pose a risk to participant safety (eg, second-degree atrioventricular block type II). * Has known moderate or severe (per investigator's judgment) aortic valve stenosis at screening. * History of LV systolic dysfunction (LVEF \< 45%) at any time during their clinical course. * Clinically significant pulmonary disease associated with exertional dyspnea. * Has known significant unrevascularized obstructive coronary artery disease (\>70% stenosis in one or more main epicardial coronary arteries) or history of myocardial infarction Note: participants with prior coronary artery bypass grafting (CABG) or percutaneous coronary interventions (PCIs) are allowed if the procedure was performed at least 12 weeks prior to screening * Prior treatment with cardiotoxic agents such as anthracyclines (eg, doxorubicin) or similar Other protocol-defined criteria apply.

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Conditions

The condition(s) this trial relates to.

hypertrophic cardiomyopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiomyopathy, hypertrophic

Contacts and locations

Locations

  • Local Institution - 0001

    Kansas City, Kansas, 66103-2937, United States

  • Local Institution - 0002

    El Palmar, MU, 30120, Spain

  • Local Institution - 0003

    Valencia, V, 46026, Spain

  • Local Institution - 0005

    Florence, FI, 50134, Italy

  • Local Institution - 0006

    Salt Lake City, Utah, 84132, United States

  • Local Institution - 0008

    Málaga, MA, 29010, Spain

  • Local Institution - 0009

    A Coruña, 15006, Spain

  • Local Institution - 0010

    Majadahonda, 28035, Spain

  • Local Institution - 0011

    Katowice, Silesian Voivodeship, 40-555, Poland

  • Local Institution - 0013

    Durham, North Carolina, 27710, United States

  • Local Institution - 0014

    Los Angeles, California, 90048, United States

  • Local Institution - 0015

    Cleveland, Ohio, 44195-0001, United States

  • Local Institution - 0016

    San Francisco, California, 94158-2156, United States

  • Local Institution - 0021

    Nashville, Tennessee, 37205-2202, United States

  • Local Institution - 0022

    Granada, GR, 18014, Spain

  • Local Institution - 0023

    Barcelona, 08036, Spain

  • Local Institution - 0024

    Portland, Oregon, 97239-3011, United States

  • Local Institution - 0025

    San Antonio, Texas, 78229-3900, United States

  • Local Institution - 0026

    La Jolla, California, 92037, United States

  • Local Institution - 0027

    Bologna, BO, 40138, Italy

  • Local Institution - 0028

    Alicante, A, 03010, Spain

  • Local Institution - 0029

    Milan, 20138, Italy

  • Local Institution - 0030

    Wroclaw, 54-049, Poland

  • Local Institution - 0031

    Cincinnati, Ohio, 45267, United States

  • Local Institution - 0032

    New York, New York, 10032-3802, United States

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