THE WOODLANDS, Texas, July 27, 2026
Lexicon Pharmaceuticals, Inc. announced the completion of patient enrollment and randomization in the pivotal Phase 3 SONATA-HCM clinical trial evaluating sotagliflozin for the treatment of symptomatic non-obstructive (nHCM) and obstructive hypertrophic cardiomyopathy (oHCM). The multinational study surpassed its enrollment target of 500 patients, recruiting participants from more than 130 clinical sites across 20 countries. The trial will evaluate whether sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, can improve symptoms in patients living with hypertrophic cardiomyopathy (HCM), a chronic and progressive cardiovascular disease. Topline results are expected during the first quarter of 2027, marking the next major milestone in the clinical development of the investigational therapy.
Largest Phase 3 Trial Evaluating Both HCM Patient Populations
SONATA-HCM is the only ongoing Phase 3 clinical trial studying both non-obstructive and obstructive HCM and represents the largest Phase 3 study conducted in these combined patient populations. The randomized, double-blind, placebo-controlled trial is designed to assess the impact of sotagliflozin on symptoms, physical function, patient-reported outcomes, and safety over a 26-week treatment period. The primary efficacy endpoint measures changes in symptoms using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS). The final study population includes a substantial majority of patients with non-obstructive HCM, an area where effective treatment options remain limited, while also enrolling a meaningful cohort of patients with obstructive disease. Participants receiving stable guideline-directed HCM therapies, including cardiac myosin inhibitors, were eligible to participate under specified study criteria.
Investigators Highlight Need for Additional HCM Therapies
According to Craig Granowitz, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Lexicon Pharmaceuticals, completing enrollment represents an important milestone for patients affected by hypertrophic cardiomyopathy, many of whom continue to experience persistent symptoms despite currently available therapies. The company believes sotagliflozin’s unique dual inhibition of SGLT1 and SGLT2 may provide a differentiated treatment approach compared with existing options. Dr. Sharlene M. Day, co-principal investigator of the study and Director of Translational Research at the Penn Cardiovascular Institute, noted that additional therapies capable of improving symptoms and daily functioning remain a significant unmet need for HCM patients. Dr. Carolyn Y. Ho, co-principal investigator and Professor of Medicine at Harvard Medical School, also emphasized the importance of patient participation in advancing research that could expand future treatment options for both obstructive and non-obstructive forms of the disease.
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Sotagliflozin Program Advances Toward Key Clinical Readout
Sotagliflozin was discovered through Lexicon Pharmaceuticals’ gene science platform and is an oral dual inhibitor of sodium-glucose cotransporter 1 (SGLT1) and sodium-glucose cotransporter 2 (SGLT2), targeting glucose regulation in both the gastrointestinal tract and the kidneys. The investigational therapy has previously been studied in approximately 20,000 patients across clinical programs involving heart failure, diabetes, and chronic kidney disease, and is now being evaluated for its potential role in hypertrophic cardiomyopathy. With enrollment successfully completed and the trial progressing as planned, Lexicon Pharmaceuticals expects topline Phase 3 SONATA-HCM results in the first quarter of 2027. Positive findings could support the development of a new therapeutic option for patients with symptomatic HCM, particularly those with non-obstructive disease, where treatment choices remain limited.
Source: Lexicon Pharmaceuticals press release
