Evaluating Sotagliflozin for Symptomatic Hypertrophic Cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Lexicon Investigational Site (4041)
  Phoenix, Arizona, United States Recruiting
• Lexicon Investigational Site (4037)
  Scottsdale, Arizona, United States Recruiting
• Lexicon Investigational Site (4012)
  Los Angeles, California, United States Recruiting
• Lexicon Investigational Site (4035)
  Pomona, California, United States Recruiting
• Lexicon Investigational Site (4044)
  San Francisco, California, United States Recruiting
• Lexicon Investigational Site (4046)
  Jacksonville, Florida, United States Recruiting

+57 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Tracy Newbold
• Email: tnewbold@lexpharma.com
• Phone: 281-863-3016

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ninerafaxstat for symptomatic non-obstructive hypertrophic cardiomyopathy

  This trial will test whether taking ninerafaxstat with usual care helps adults with symptomatic non-obstructive hypertrophic cardiomyopathy feel better and improve exercise capacity compared with a placebo.

  Recruiting at 63 sites Phase 2 Imbria Pharmaceuticals, Inc. · La Jolla, California and 75 other locations · NCT07023614

• Comparing Bisoprolol and Verapamil for treating symptoms in patients with non-obstructive hypertrophic cardiomyopathy

  This study tests whether Bisoprolol or Verapamil can help people with non-obstructive hypertrophic cardiomyopathy feel better by reducing symptoms like shortness of breath and chest pain.

  Recruiting at 2 sites Phase 4 Aarhus University Hospital Skejby · Aarhus N and 3 other locations · NCT05569382

• Assessing health changes in patients with obstructive hypertrophic cardiomyopathy treated with mavacamten

  This study is testing how well the medication mavacamten helps adults with obstructive hypertrophic cardiomyopathy feel and do better in their everyday lives.

  Recruiting Bristol-Myers Squibb · Boston, Massachusetts · NCT06551129

• Assessing the safety of mavacamten in Korean patients with obstructive hypertrophic cardiomyopathy

  This study is testing how safe the medication mavacamten is for adults in Korea who have symptoms of obstructive hypertrophic cardiomyopathy.

  Recruiting Bristol-Myers Squibb · Seoul and 1 other locations · NCT06146660

• Effect of mavacamten on heart blood flow in obstructive hypertrophic cardiomyopathy

  This study is testing if the medication mavacamten can improve blood flow in the hearts of people with obstructive hypertrophic cardiomyopathy after a year of treatment.

  Recruiting University of Virginia · Charlottesville, Virginia · NCT06023186

• Registry to assess patient characteristics and outcomes in obstructive hypertrophic cardiomyopathy

  This study is trying to learn more about how people with obstructive hypertrophic cardiomyopathy are treated and what their experiences are, especially for those using the medication mavacamten.

  Recruiting at 76 sites Bristol-Myers Squibb · Anchorage, Alaska and 100 other locations · NCT05489705

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.