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)
Lexicon Pharmaceuticals
Summary
The main purpose of the study is to determine the changes in symptoms and functional limitations in participants with symptomatic hypertrophic cardiomyopathy (HCM) treated with sotagliflozin as compared to placebo.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugSotagliflozin
Sotagliflozin will be administered as a tablet(s), orally once daily.
- DrugPlacebo
Placebo will be administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
Locations (107)
- Lexicon Investigational Site (4041)Phoenix, Arizona
- Lexicon Investigational Site (4037)Scottsdale, Arizona
- Lexicon Investigational Site (4012)Los Angeles, California
- Lexicon Investigational Site (4035)Pomona, California
- Lexicon Investigational Site (4044)San Francisco, California
- Lexicon Investigational Site (4046)Jacksonville, Florida