Clinical TrialJul 27, 2026, 08:32 AM
Lexicon Completes Patient Enrollment for SONATA-HCM Phase 3 Trial
AI Summary
Lexicon Pharmaceuticals announced the completion of patient randomization for its pivotal Phase 3 SONATA-HCM clinical trial, evaluating sotagliflozin for hypertrophic cardiomyopathy. The study significantly surpassed its enrollment target of 500 patients, recruiting participants across over 130 sites in 20 countries. Topline results from the trial are expected in the first quarter of 2027, marking a key milestone for the potential treatment of symptomatic HCM.
Key Highlights
- Patient randomization completed for pivotal Phase 3 SONATA-HCM clinical trial.
- Study substantially exceeded enrollment target of 500 patients.
- Trial conducted across more than 130 sites in 20 countries.
- Primary efficacy endpoint assesses symptom improvement for entire population (nHCM and oHCM).
- Final study population includes a substantial majority of non-obstructive HCM patients.
- Topline results for the SONATA-HCM trial are anticipated in Q1 2027.
- Sotagliflozin is a dual SGLT1 and SGLT2 inhibitor.
- SONATA-HCM is the largest Phase 3 study including both nHCM and oHCM to date.
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