Cardiomyopathy, HypertrophicPhase 2MERCUTIONCT05556343
A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
A Phase 2 study testing MYK-224 in people with Cardiomyopathy, Hypertrophic, run by Bristol-Myers Squibb at 25 sites in 4 countries.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiomyopathy, Hypertrophic
- What is being tested?
- MYK-224
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 25 sitesin 4 countries
- Study dates
- 18 Jan 2023to 27 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 16Show fewer
- 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.
Trial locations and contacts
25 sites in 4 countries.
25 sites in 4 countries
United States12 sites
Local Institution - 0031
Cincinnati, Ohio, 45267
Local Institution - 0015
Cleveland, Ohio, 44195-0001
Local Institution - 0013
Durham, North Carolina, 27710
Local Institution - 0001
Kansas City, Kansas, 66103-2937
Local Institution - 0026
La Jolla, California, 92037
Local Institution - 0014
Los Angeles, California, 90048
Local Institution - 0021
Nashville, Tennessee, 37205-2202
Local Institution - 0032
New York, New York, 10032-3802
Local Institution - 0024
Portland, Oregon, 97239-3011
Local Institution - 0006
Salt Lake City, Utah, 84132
Local Institution - 0025
San Antonio, Texas, 78229-3900
Local Institution - 0016
San Francisco, California, 94158-2156
Spain8 sites
Local Institution - 0009
A Coruña, 15006
Local Institution - 0028
Alicante, A, 03010
Local Institution - 0023
Barcelona, 08036
Local Institution - 0002
El Palmar, MU, 30120
Local Institution - 0022
Granada, GR, 18014
Local Institution - 0010
Majadahonda, 28035
Local Institution - 0008
Málaga, MA, 29010
Local Institution - 0003
Valencia, V, 46026
Italy3 sites
Local Institution - 0027
Bologna, BO, 40138
Local Institution - 0005
Florence, FI, 50134
Local Institution - 0029
Milan, 20138
Poland2 sites
Local Institution - 0011
Katowice, Silesian Voivodeship, 40-555
Local Institution - 0030
Wroclaw, 54-049
About this study
Official title: A Phase 2a, Open-label, Pilot Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction (MERCUTIO)
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)
- Conditions
- Cardiomyopathy, Hypertrophic
- Being tested
- MYK-224
- Keywords
- Obstructive Hypertrophic Cardiomyopathy, MYK-224, BMS-986435, HCM
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MYK-224Drug
Also called BMS-986435
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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 Receives: Drug: MYK-224 |
| Cohort 2 | Experimental | 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 Receives: Drug: MYK-224 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of Participants With Adverse Events and Serious Adverse Events
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.
Measured: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Number of Participants With at Least One Event of Arrhythmias
Arrhythmias included atrial fibrillation/flutter (new from screening and recurrent), ventricular tachyarrhythmias (ventricular tachycardia, ventricular fibrillation, and Torsades de Pointe).
Measured: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Number of Participants With at Least One Event of Appropriate Implantable Cardioverter Defibrillator Therapy and Resuscitated Cardiac Arrest
Measured: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Change From Baseline in Vital Signs - Heart Rate
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Heart rate was measured in rested state.
Measured: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Change From Baseline in Vital Signs - Mean Systolic Blood Pressure
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Systolic blood pressure was measured in rested state.
Measured: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Change From Baseline in Vital Signs - Mean Diastolic Blood Pressure
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Diastolic blood pressure was measured in rested state.
Measured: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Change From Baseline in Vital Signs - Respiratory Rate
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Respiratory rate was measured in rested state.
Measured: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Change From Baseline in Vital Signs - Temperature
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224.
Measured: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Change From Baseline in Vital Signs - Weight
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224.
Measured: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Number of Participants With Abnormal Physical Examination Results
The complete physical examination included weight and calculated BMI, a neurological examination (gross motor and deep tendon reflexes),and an assessment of the following: general appearance, skin, head and neck, mouth, lymph nodes, thyroid, abdomen, musculoskeletal, cardiovascular, neurological, and respiratory systems with other systems included, as directed by interval history.
Measured: Baseline and until study end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Results
Twelve-lead ECG evaluations will be performed in the supine position after 10 minutes of rest at Screening and at selected clinic visits prior to MYK-224 dosing and before any blood sample collection. QTc prolongation is defined by either the mean of QTcF > 499 or mean of QTcB > 499 according to the project requirement specification from Clario.
Measured: Baseline and until study end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Number of Participants With Adverse Events Related to Clinical Laboratory Parameters (Hematology, Chemistry and Urinalysis)
Blood samples were collected to assess the clinical laboratory parameters.
Measured: Baseline and untill end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A:Percentage of Participants With Incidence of Symptomatic Left Ventricular Ejection Fraction (LVEF) < 50%
LVEF was assessed using transthoracic echocardiogram (TTE) in resting state. 90% CIs are calculated based on Exact Binomial proportion test. LVEF value was calculated by Simpson Biplane method.
Measured: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Percentage of Participants With Incidence of Symptomatic Left Ventricular Ejection Fraction (LVEF) <= 30%
LVEF was assessed using transthoracic echocardiogram (TTE) in resting state. 90% CIs are calculated based on Exact Binomial proportion test. LVEF value was calculated by Simpson Biplane method.
Measured: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)
Secondary outcomes (6)
Part A: Aggregate Mean of Left Ventricular Ejection Fraction (LVEF)
Measured: Treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Participants with data available at the timepoint were included in the analysis.
Measured: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Aggregate Mean of Left Ventricular Outflow Tract (LVOT) Peak Gradient (Post-Exercise, Resting, and Valsalva)
Measured: Treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Change From Baseline in Left Ventricular Outflow Tract (LVOT) Peak Gradient (Post-Exercise, Resting, and Valsalva)
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Participants with data available at the timepoint were included in the analysis.
Measured: Treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Percentage of Participants With Resting Left Ventricular Outflow Tract (LVOT) Peak Gradient < 30 mmHg and Valsalva LVOT Peak Gradient < 50 mmHg
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. 90%CIs are calculated based on Normal approximation.
Measured: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Plasma Concentration of MYK-224
Blood samples were collected to assess plasma concentration of MYK-224.
Measured: Pre-dose and 1 hour post-dose end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start18 Jan 2023
- Primary completion19 Aug 2024
- Study completion27 Feb 2025
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiomyopathy, HypertrophicStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556343
- Sponsor's protocol ID
- CV029-009
- Other IDs
- 2022-001292-14, U1111-1276-3555
- Acronym
- MERCUTIO
- Status last verified
- Jun 2026
- First submitted
- 23 Sep 2022
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-label, Pilot Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction (MERCUTIO)
- ClinicalTrials.gov ID
- NCT05556343
- Acronym / sponsor ID
- MERCUTIO / CV029-009
- Conditions
- Cardiomyopathy, Hypertrophic
- Keywords
- Obstructive Hypertrophic Cardiomyopathy, MYK-224, BMS-986435, HCM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 27 Sep 2022 (actual)
- Results
- Posted 2 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: MYK-224Participants 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 |
| Cohort 2 | Experimental | Drug: MYK-224Participants 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MYK-224Also: BMS-986435Specified dose on specified days | Drug | Cohort 1, Cohort 2 |
Primary outcome
Part A: Number of Participants With Adverse Events and Serious Adverse Events
Time frame: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.
Part A: Number of Participants With at Least One Event of Arrhythmias
Time frame: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)
Arrhythmias included atrial fibrillation/flutter (new from screening and recurrent), ventricular tachyarrhythmias (ventricular tachycardia, ventricular fibrillation, and Torsades de Pointe).
Part A: Number of Participants With at Least One Event of Appropriate Implantable Cardioverter Defibrillator Therapy and Resuscitated Cardiac Arrest
Time frame: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Change From Baseline in Vital Signs - Heart Rate
Time frame: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Heart rate was measured in rested state.
Part A: Change From Baseline in Vital Signs - Mean Systolic Blood Pressure
Time frame: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Systolic blood pressure was measured in rested state.
Part A: Change From Baseline in Vital Signs - Mean Diastolic Blood Pressure
Time frame: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Diastolic blood pressure was measured in rested state.
Part A: Change From Baseline in Vital Signs - Respiratory Rate
Time frame: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224. Respiratory rate was measured in rested state.
Part A: Change From Baseline in Vital Signs - Temperature
Time frame: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224.
Part A: Change From Baseline in Vital Signs - Weight
Time frame: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Baseline is defined as the last non-missing value in date/time recorded before the first dose of MYK-224.
Part A: Number of Participants With Abnormal Physical Examination Results
Time frame: Baseline and until study end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
The complete physical examination included weight and calculated BMI, a neurological examination (gross motor and deep tendon reflexes),and an assessment of the following: general appearance, skin, head and neck, mouth, lymph nodes, thyroid, abdomen, musculoskeletal, cardiovascular, neurological, and respiratory systems with other systems included, as directed by interval history.
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Results
Time frame: Baseline and until study end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Twelve-lead ECG evaluations will be performed in the supine position after 10 minutes of rest at Screening and at selected clinic visits prior to MYK-224 dosing and before any blood sample collection. QTc prolongation is defined by either the mean of QTcF > 499 or mean of QTcB > 499 according to the project requirement specification from Clario.
Part A: Number of Participants With Adverse Events Related to Clinical Laboratory Parameters (Hematology, Chemistry and Urinalysis)
Time frame: Baseline and untill end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Blood samples were collected to assess the clinical laboratory parameters.
Part A:Percentage of Participants With Incidence of Symptomatic Left Ventricular Ejection Fraction (LVEF) < 50%
Time frame: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)
LVEF was assessed using transthoracic echocardiogram (TTE) in resting state. 90% CIs are calculated based on Exact Binomial proportion test. LVEF value was calculated by Simpson Biplane method.
Part A: Percentage of Participants With Incidence of Symptomatic Left Ventricular Ejection Fraction (LVEF) <= 30%
Time frame: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)
LVEF was assessed using transthoracic echocardiogram (TTE) in resting state. 90% CIs are calculated based on Exact Binomial proportion test. LVEF value was calculated by Simpson Biplane method.
6 secondary outcomes
Part A: Aggregate Mean of Left Ventricular Ejection Fraction (LVEF)
Time frame: Treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Aggregate Mean of Left Ventricular Outflow Tract (LVOT) Peak Gradient (Post-Exercise, Resting, and Valsalva)
Time frame: Treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Change From Baseline in Left Ventricular Outflow Tract (LVOT) Peak Gradient (Post-Exercise, Resting, and Valsalva)
Time frame: Treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Percentage of Participants With Resting Left Ventricular Outflow Tract (LVOT) Peak Gradient < 30 mmHg and Valsalva LVOT Peak Gradient < 50 mmHg
Time frame: Baseline and until treatment end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Part A: Plasma Concentration of MYK-224
Time frame: Pre-dose and 1 hour post-dose end date in Part A (Median 17.55 weeks and Maximum 54.9 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MYK-224 in people with Cardiomyopathy, Hypertrophic, run by Bristol-Myers Squibb at 25 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Spain, Italy, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Number of Participants With Adverse Events and Serious Adverse Events (time frame: From first dose (Day 1) until study end date in Part A or 30 days after early termination date (Median 17.55 weeks and Maximum 54.9 weeks)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.