Lexicon Pharmaceuticals, Inc. announced on May 19, 2025, that details of its SONATA-HCM study design were presented at Heart Failure 2025, the Annual Congress of the Heart Failure Association of the European Society of Cardiology. This pivotal Phase 3 clinical trial is evaluating the safety and efficacy of sotagliflozin in patients with both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM).
Enrollment in the SONATA-HCM study is actively underway in 20 countries, with all study sites expected to be operational by September 2025. The study is designed to enroll 500 patients worldwide, split evenly between obstructive and non-obstructive HCM.
The primary efficacy endpoint for the study is improvement in symptoms, measured by the change from baseline to week 26 in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS). Lexicon believes the study results could support a supplemental new drug application (sNDA) for sotagliflozin for a broad HCM indication.
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