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)
| Registry | NCT06481891, acronym SONATA-HCM |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 500 (Estimated) |
| Sponsor | Lexicon Pharmaceuticals (Industry) |
| Conditions | Obstructive Cardiomyopathy, Hypertrophic, Non-obstructive Hypertrophic Cardiomyopathy |
| Interventions | Sotagliflozin, Placebo (Drug) |
| Dates | start 2024-09-24, primary completion 2027-01-01 (estimated), completion 2027-02-01 (estimated), first posted 2024-07-01, last updated 2026-08-26 |
| Locations | 108 sites in United States, Argentina, Belgium, Brazil, Bulgaria, Croatia, Czechia, France and 11 more countries |
Related Papers Related Patents Related Grants Related Experts
All trials for Obstructive Cardiomyopathy, Hypertrophic All trials for Non-obstructive Hypertrophic Cardiomyopathy All trials of Sotagliflozin All trials of Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sotagliflozin | Experimental | Drug: Sotagliflozin | Following an up to 3-week screening period, sotagliflozin 400 milligrams (mg) tablets will be administered as two 200 mg tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
| Placebo | Placebo comparator | Drug: Placebo | Following an up to 3-week screening period, sotagliflozin-matching placebo 400 mg tablets will be administered as two 200 mg tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Lexicon Investigational Site (4041) | Phoenix, Arizona | United States | |
| Lexicon Investigational Site (4037) | Scottsdale, Arizona | United States | |
| Lexicon Investigational Site (4012) | Los Angeles, California | United States | |
| Lexicon Investigational Site (4035) | Pomona, California | United States | |
| Lexicon Investigational Site (4044) | San Francisco, California | United States | |
| Lexicon Investigational Site (4046) | Jacksonville, Florida | United States | |
| Lexicon Investigational Site (4034) | Orlando, Florida | United States | |
| Lexicon Investigational Site (4018) | Atlanta, Georgia | United States | |
| Lexicon Investigational Site (4033) | Evanston, Illinois | United States | |
| Lexicon Investigational Site (4036) | Merrillville, Indiana | United States | |
| Lexicon Investigational Site (4021) | Baltimore, Maryland | United States | |
| Lexicon Investigational Site (4016) | Boston, Massachusetts | United States | |
| Lexicon Investigational Site (4042) | Boston, Massachusetts | United States | |
| Lexicon Investigational Site (4028) | Ann Arbor, Michigan | United States | |
| Lexicon Investigational Site (4038) | Grand Rapids, Michigan | United States | |
| Lexicon Investigational Site (4027) | Rochester, Minnesota | United States | |
| Lexicon Investigational Site (4013) | St Louis, Missouri | United States | |
| Lexicon Investigational Site (4029) | Morristown, New Jersey | United States | |
| Lexicon Investigational Site (4039) | Manhasset, New York | United States | |
| Lexicon Investigational Site (4043) | New York, New York | United States | |
| Lexicon Investigational Site (4026) | Morrisville, North Carolina | United States | |
| Lexicon Investigational Site (4031) | Cincinnati, Ohio | United States | |
| Lexicon Investigational Site (4017) | Cleveland, Ohio | United States | |
| Lexicon Investigational Site (4024) | Tulsa, Oklahoma | United States | |
| Lexicon Investigational Site (4015) | Portland, Oregon | United States | |
| Lexicon Investigational Site (4011) | Philadelphia, Pennsylvania | United States | |
| Lexicon Investigational Site (4019) | Germantown, Tennessee | United States | |
| Lexicon Investigational Stie (4014) | Houston, Texas | United States | |
| Lexicon Investigational Site (4032) | Charlottesville, Virginia | United States | |
| Lexicon Investigational Site (4045) | Seattle, Washington | United States | |
| Lexicon Investigational Site (4010) | Seattle, Washington | United States | |
| Lexicon Investigational Site (4022) | Marshfield, Wisconsin | United States | |
| Lexicon Investigational Site (4040) | Milwaukee, Wisconsin | United States | |
| Lexicon Investigational Site (5016) | Santa Rosa, La Pampa Province | Argentina | |
| Lexicon Investigational Site (5012) | Rosario, Santa Fe Province | Argentina | |
| Lexicon Investigational Site (5014) | Santa Fe, Santa Fe Province | Argentina | |
| Lexicon Investigational Site (5015) | Corrientes | Argentina | |
| Lexicon Investigational Site (5010) | Córdoba | Argentina | |
| Lexicon Investigational Site (5013) | Córdoba | Argentina | |
| Lexicon Investigational Site (5011) | Salta | Argentina | |
| Lexicon Investigational Site (1012) | Genk | Belgium | |
| Lexicon Investigational Site (5114) | Salvador, Estado de Bahia | Brazil | |
| Lexicon Investigational Site (5110) | Campinas, São Paulo | Brazil | |
| Lexicon Investigational Site (5112) | Recife | Brazil | |
| Lexicon Investigational Site (5115) | São Paulo | Brazil | |
| Lexicon Investigational Site (1112) | Rousse | Bulgaria | |
| Lexicon Investigational Site (1111) | Sofia | Bulgaria | |
| Lexicon Investigational Site (1215) | Krapinske Toplice | Croatia | |
| Lexicon Investigational Site (1212) | Opatija | Croatia | |
| Lexicon Investigational Site (1210) | Rijeka | Croatia | |
| Lexicon Investigational Site (1213) | Zagreb | Croatia | |
| Lexicon Investigational Site (1311) | Brno | Czechia | |
| Lexicon Investigational Site (1310) | Prague | Czechia | |
| Lexicon Investigational Site (1312) | Ústí nad Labem | Czechia | |
| Lexicon Investigational Site (1514) | Chambray-lès-Tours | France | |
| Lexicon Investigational Site (1511) | Marseille | France | |
| Lexicon Investigational Site (1513) | Paris | France | |
| Lexicon Investigational Site (1510) | Poitiers | France | |
| Lexicon Investigational Site (1512) | Rennes | France | |
| Lexicon Investigational Site (1515) | Toulouse | France | |
| Lexicon Investigational Site (1611) | Tbilisi | Georgia | |
| Lexicon Investigational Site (1610) | Tbilisi | Georgia | |
| Lexicon Investigational Site (1612) | Tbilisi | Georgia | |
| Lexicon Investigational Site (1613) | Tbilisi | Georgia | |
| Lexicon Investigational Site (2813) | Berlin | Germany | |
| Lexicon Investigational Site (2812) | Hamburg | Germany | |
| Lexicon Investigational Site (2811) | Leipzig | Germany | |
| Lexicon Investigational Site (2810) | München | Germany | |
| Lexicon Investigational Site (1710) | Budapest | Hungary | |
| Lexicon Investigational Site (1711) | Pécs | Hungary | |
| Lexicon Investigational Site (1712) | Szeged | Hungary | |
| Lexicon Investigational Site (1713) | Zalaegerszeg | Hungary | |
| Lexicon Investigational Site (7017) | Be’er Ya‘aqov | Israel | |
| Lexicon Investigational Site (7013) | Haifa | Israel | |
| Lexicon Investigational Site (7014) | Haifa | Israel | |
| Lexicon Investigational Site (7015) | Holon | Israel | |
| Lexicon Investigational Site (7011) | Jerusalem | Israel | |
| Lexicon Investigational Site (7016) | Petah Tikva | Israel | |
| Lexicon Investigational Site (7012) | Ramat Gan | Israel | |
| Lexicon Investigational Site (7019) | Tel Aviv | Israel | |
| Lexicon Investigational Site (1814) | Arezzo | Italy | |
| Lexicon Investigational Site (1811) | Brescia | Italy | |
| Lexicon Investigational Site (1813) | Naples | Italy | |
| Lexicon Investigational Site (2114) | Lodz | Poland | |
| Lexicon Investigational Site (2113) | Lodz | Poland | |
| Lexicon Investigational Site (2115) | Oświęcim | Poland | |
| Lexicon Investigational Site (2110) | Wroclaw | Poland | |
| Lexicon Investigational Site (2210) | Braga | Portugal | |
| Lexicon Investigational Site (2213) | Faro | Portugal | |
| Lexicon Investigational Site (2211) | Lisbon | Portugal | |
| Lexicon Investigational Site (2215) | Lisbon | Portugal | |
| Lexicon Investigational Site (2218) | Lisbon | Portugal | |
| Lexicon Investigational Site (2216) | Lisbon | Portugal | |
| Lexicon Investigational Site (2217) | Porto | Portugal | |
| Lexicon Investigational Site (2910) | Baloteşti | Romania | |
| Lexicon Investigational Site (2913) | Suceava | Romania | |
| Lexicon Investigational Site (2911) | Târgu Mureş | Romania | |
| Lexicon Investigational Site (2912) | Târgu Mureş | Romania | |
| Lexicon Investigational Site (2312) | Belgrade | Serbia | |
| Lexicon Investigational Site (2314) | Belgrade | Serbia |
8 more sites not listed.