Lexicon Pharmaceuticals Provides Update on Baseline Patient Characteristics for Pivotal Phase 3 SONATA-HCM Study of Sotagliflozin in Symptomatic Hypertrophic Cardiomyopathy
Globe Newswire•23/10/2026•08:30 ET
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Key Highlights
- ➤SONATA-HCM enrolled 542 patients, exceeding its 500-patient target
- ➤SONATA-HCM includes 440 non-obstructive and 102 obstructive HCM patients
- ➤Mean baseline KCCQ-CSS was 59, indicating substantial symptom burden
- ➤Topline SONATA-HCM results are anticipated in the first quarter of 2027
Expert Statements
Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Lexicon Pharmaceuticals
“We designed SONATA-HCM to evaluate sotagliflozin in a broad and clinically relevant HCM population reflective of real-world clinical practice, and we are very pleased that the final study population met that objective.”
Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Lexicon Pharmaceuticals
“The demographic and clinical characteristics of both the obstructive and non-obstructive HCM cohorts were generally consistent with those reported in previous studies of other agents, while the baseline KCCQ score reflects a population with meaningful symptom burden.”
Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Lexicon Pharmaceuticals
“Combined with the substantial over enrollment and representation of both major HCM subtypes, we believe SONATA-HCM is well positioned to evaluate sotagliflozin across the broad spectrum of symptomatic HCM patients.”
-- Patient demographics consistent with prior studies of other agents in HCM and reflect real-world clinical practice --
-- Mean baseline KCCQ-CSS of 59 shows considerable symptom burden at study entry –
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