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Evaluating Sotagliflozin for Symptomatic Hypertrophic Cardiomyopathy

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in symptomATic Obstructive And Non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)

Phase 3 Interventional Lexicon Pharmaceuticals · NCT06481891

This study is testing if a new medication called sotagliflozin can help people with symptomatic hypertrophic cardiomyopathy feel better and improve their daily activities.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorLexicon Pharmaceuticals Industry-sponsored
Locations107 sites (Phoenix, Arizona and 106 other locations)
Trial IDNCT06481891 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of sotagliflozin in patients with symptomatic hypertrophic cardiomyopathy (HCM), both obstructive and non-obstructive types. Participants will be treated with either sotagliflozin or a placebo, and the study will measure changes in symptoms and functional limitations. The study is designed to determine how well sotagliflozin improves the quality of life for individuals suffering from this condition compared to those receiving placebo treatment.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with symptomatic hypertrophic cardiomyopathy who have specific functional limitations and echocardiographic findings.

Not a fit: Patients with asymptomatic hypertrophic cardiomyopathy or those with other significant cardiac or systemic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve symptoms and functional capacity for patients with hypertrophic cardiomyopathy.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating other forms of heart disease with SGLT inhibitors.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* KCCQ CSS \< 85.
* NYHA functional class II or III
* A diagnosis of HCM consistent with the current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guideline definition: unexplained left ventricular (LV) hypertrophy with nondilated ventricular chambers in the absence of other cardiac (eg, hypertension, aortic stenosis) 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 assessed by echocardiography at rest or during a valsalva maneuver.
* For nonobstructive hypertrophic cardiomyopathy (nHCM), LVOT peak gradient \< 30 mm Hg during screening as assessed by echocardiography at rest and \< 30 mm Hg during a valsalva maneuver.
* Screening left ventricular ejection fraction (LVEF) ≥ 50%, except for those on a cardiac myosin inhibitor (screening LVEF ≥ 55%).
* For participants on a cardiac myosin inhibitor, the dose must be stable at least 3 months prior to screening. Participants on cardiac myosin inhibitor should not be scheduled 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 the past 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 prior participation in any interventional trial with an investigational agent within 45 days of screening.
* Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM such 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 appropriate implantable cardioverter defibrillator (ICD) discharge within 6 months prior to screening.
* Has paroxysmal, persistent, or permanent atrial fibrillation not on anticoagulation for 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 had septal reduction therapy, the procedure should have been completed more than 3 months prior to screening.
* Cardiac surgery (eg, coronary artery bypass graft, valvular repair/replacement), percutaneous coronary intervention, or implantation of cardiac device (pacemaker or implantable cardioverter defibrillator) within 3 months prior to screening or planned 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 stenosis at screening.
* Current angina or clinically significant ischemia due to unstable epicardial coronary disease, as per investigator judgment.

Where this trial is running

Phoenix, Arizona and 106 other locations

+57 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Obstructive Cardiomyopathy, HypertrophicNon-obstructive Hypertrophic Cardiomyopathy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.