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RECRUITING

NCT06481891

PHASE3

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

Sponsor: Lexicon Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-09-24

Completion Date

2026-08

Last Updated

2026-02-27

Healthy Volunteers

Conditions

Obstructive Cardiomyopathy, Hypertrophic Non-obstructive Hypertrophic Cardiomyopathy

Interventions

DRUG

Sotagliflozin

Sotagliflozin will be administered as a tablet(s), orally once daily.

DRUG

Placebo

Placebo will be administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.

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.

Locations (107)

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 (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 (5015)

Corrientes, Argentina

Lexicon Investigational Site (5010)

Córdoba, Argentina

Lexicon Investigational Site (5013)

Córdoba, Argentina

Lexicon Investigational Site (5011)

Salta, Argentina

Lexicon Investigational Site (5014)

Santa Fe, 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

Lexicon Investigational Site (2311)

Belgrade, Serbia

Lexicon Investigational Site (2313)

Belgrade, Serbia

Lexicon Investigational Site (2310)

Niš, Serbia

Lexicon Investigational Site (2510)

Stockholm, Sweden

Lexicon Investigational Site (2712)

Glasgow, United Kingdom

Lexicon Investigational Site (2713)

Leicester, United Kingdom

Lexicon Investigational Site (2710)

Liverpool, United Kingdom

Lexicon Investigational Site (2711)

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (107)