A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
NCT ID: NCT05556343
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
18 participants
INTERVENTIONAL
2023-01-18
2025-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
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
MYK-224
Specified dose on specified days
Cohort 2
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
MYK-224
Specified dose on specified days
Interventions
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MYK-224
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0026
La Jolla, California, United States
Local Institution - 0014
Los Angeles, California, United States
Local Institution - 0016
San Francisco, California, United States
Local Institution - 0001
Kansas City, Kansas, United States
Local Institution - 0032
New York, New York, United States
Local Institution - 0013
Durham, North Carolina, United States
Local Institution - 0031
Cincinnati, Ohio, United States
Local Institution - 0015
Cleveland, Ohio, United States
Local Institution - 0024
Portland, Oregon, United States
Local Institution - 0021
Nashville, Tennessee, United States
Local Institution - 0025
San Antonio, Texas, United States
Local Institution - 0006
Salt Lake City, Utah, United States
Local Institution - 0027
Bologna, BO, Italy
Local Institution - 0005
Florence, FI, Italy
Local Institution - 0029
Milan, , Italy
Local Institution - 0011
Katowice, Silesian Voivodeship, Poland
Local Institution - 0030
Wroclaw, , Poland
Local Institution - 0028
Alicante, A, Spain
Local Institution - 0022
Granada, GR, Spain
Local Institution - 0008
Málaga, MA, Spain
Local Institution - 0002
El Palmar, MU, Spain
Local Institution - 0003
Valencia, V, Spain
Local Institution - 0009
A Coruña, , Spain
Local Institution - 0023
Barcelona, , Spain
Local Institution - 0010
Majadahonda, , Spain
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2022-001292-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1276-3555
Identifier Type: REGISTRY
Identifier Source: secondary_id
CV029-009
Identifier Type: -
Identifier Source: org_study_id
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