A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy

Inclusion Criteria:

• KCCQ CSS < 85.

• NYHA functional class II or III

• A diagnosis of HCM consistent with the current American College of CardiologyFoundation/American Heart Association and European Society of Cardiology guidelinedefinition: unexplained left ventricular (LV) hypertrophy with nondilatedventricular chambers in the absence of other cardiac (eg, hypertension, aorticstenosis) or systemic disease with maximal LV wall thickness ≥ 15 millimeters (mm),or ≥ 13 mm with positive family history of HCM.

• For obstructive hypertrophic cardiomyopathy (oHCM), left ventricular outflow tract (LVOT) peak gradient ≥ 30 millimetre of mercury (mm Hg) during screening as assessedby echocardiography at rest or during a valsalva maneuver.

• For nonobstructive hypertrophic cardiomyopathy (nHCM), LVOT peak gradient < 30 mm Hgduring screening as assessed by echocardiography at rest and < 30 mm Hg during avalsalva maneuver.

• Screening left ventricular ejection fraction (LVEF) ≥ 50%, except for those on acardiac myosin inhibitor (screening LVEF ≥ 55%).

• For participants on a cardiac myosin inhibitor, the dose must be stable at least 3months prior to screening. Participants on cardiac myosin inhibitor should not bescheduled for up-titration during the trial.

• Stable doses of background therapy (ie, β-blockers, calcium channel blockers,angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers,diuretics) for at least 1 month prior to screening.

Exclusion Criteria:

• Received therapy with a sodium glucose co-transporter 2 (SGLT2) inhibitor within thepast 8 weeks prior to screening.

• Previous intolerance to an SGLT2 inhibitor.

• Any previous treatment with sotagliflozin.

• Current use of thiazolidinediones or digoxin.

• Current/planned participation in another interventional clinical trial or priorparticipation in any interventional trial with an investigational agent within 45days of screening.

• Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCMsuch as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.

• History of unexplained syncope within 6 months prior to screening.

• History of sustained ventricular tachyarrhythmia (> 30 seconds) or appropriateimplantable cardioverter defibrillator (ICD) discharge within 6 months prior toscreening.

• Has paroxysmal, persistent, or permanent atrial fibrillation not on anticoagulationfor at least 4 weeks prior to screening and/or not adequately rate controlled within 3 months of screening.

• Septal reduction therapy planned during the study period. For participants who hadseptal reduction therapy, the procedure should have been completed more than 3months prior to screening.

• Cardiac surgery (eg, coronary artery bypass graft, valvular repair/replacement),percutaneous coronary intervention, or implantation of cardiac device (pacemaker orimplantable cardioverter defibrillator) within 3 months prior to screening orplanned during the study period.

• Presence of a cardiac resynchronization therapy device.

• Acute coronary syndrome within 2 months prior to screening.

• History of stroke or myocardial infarction within 6 months prior to screening.

• Hospitalization for heart failure or arrhythmia within 4 weeks prior to screening.

• Has known moderate or severe (as per investigator's judgment) aortic valve stenosisat screening.

• Current angina or clinically significant ischemia due to unstable epicardialcoronary disease, as per investigator judgment.