Lexicon Pharmaceuticals Provides Update on Baseline Patient Characteristics for Pivotal Phase 3 SONATA-HCM Study of Sotagliflozin in Symptomatic Hypertrophic Cardiomyopathy
Lexicon Pharmaceuticals provided baseline patient characteristics for the pivotal Phase 3 SONATA-HCM study of sotagliflozin in symptomatic hypertrophic cardiomyopathy, with no efficacy data disclosed. The trial enrolled 542 patients across more than 130 sites in 20 countries, exceeding its 500-patient target, including 440 with non-obstructive and 102 with obstructive HCM. Mean baseline KCCQ-CSS of 59 indicates substantial symptom burden at study entry. Enrollment demographics were consistent with prior studies of other HCM agents, which the company says supports the study's relevance and statistical power.
Key figures
- Drug Name
- sotagliflozin
- Phase Of Trial
- Phase 3
- Sites
- more than 130
- Countries
- 20
- Nhcm patients
- 440
- Ohcm patients
- 102
- Topline timing
- Q1 2027
- Primary endpoint
- change from baseline in KCCQ-CSS at Week 26
- Patients enrolled
- 542
- Target enrollment
- 500
- Mean baseline kccq css
- 59
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