RecruitingPhase 3NCT06481891

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

Sponsor

Lexicon Pharmaceuticals

Enrollment

500 participants

Start Date

Sep 24, 2024

Study Type

INTERVENTIONAL

Conditions

Non-obstructive Hypertrophic Cardiomyopathy Obstructive Cardiomyopathy, Hypertrophic

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Sotagliflozin for people with non-obstructive hypertrophic cardiomyopathy and obstructive cardiomyopathy, hypertrophic. The study is currently recruiting participants at 108 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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(108)

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 (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

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NCT06481891

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