Sotagliflozin - (SONATA-HCM)

July 27, 2026: Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) announced completion of patient randomization/enrollment in the pivotal Phase 3 SONATA-HCM trial of sotagliflozin in symptomatic hypertrophic cardiomyopathy, including both non-obstructive (nHCM) and obstructive (oHCM) disease. Enrollment substantially exceeded the target of 500 patients, spanning more than 130 sites in 20 countries; the final population included a substantial majority of nHCM patients and a meaningful oHCM cohort.

SONATA-HCM is a randomized, double-blind, placebo-controlled multinational study evaluating sotagliflozin’s effects on symptoms, function, patient-reported outcomes, and safety. The primary endpoint is symptom improvement measured by change from baseline to week 26 in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS). Patients on stable guideline-directed HCM therapy, including cardiac myosin inhibitors, could enroll if criteria were met.

Topline results are expected in Q1 2027.