GlobeNewswire News Roomยท2025-05-19 12:00Core Insights - Lexicon Pharmaceuticals is conducting a pivotal Phase 3 clinical trial named SONATA-HCM to evaluate the safety and efficacy of sotagliflozin in patients with both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) [1][2] - The study aims to enroll 500 patients globally, with a primary efficacy endpoint focused on symptom improvement as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score [3][4] - The trial is expected to support a supplemental new drug application for sotagliflozin, addressing a significant unmet need in the treatment of non-obstructive HCM [2][4] Study Design and Objectives - SONATA-HCM is a randomized, double-blind, placebo-controlled multicenter trial [3] - The study will include 250 patients with obstructive HCM and 250 with non-obstructive HCM [3] - The primary endpoint is the change in symptoms from baseline to week 26, assessed through the KCCQ CSS survey [3] Clinical Significance - There is a notable lack of approved therapies for non-obstructive HCM, highlighting the importance of this study [4] - Sotagliflozin has shown potential benefits in heart failure patients, which may extend to HCM patients if proven effective [4] - The drug's dual inhibition of SGLT1 and SGLT2 is associated with reduced risk of major adverse cardiovascular events, as noted in recent publications [4] Company Overview - Lexicon Pharmaceuticals focuses on pioneering medicines that transform patients' lives, utilizing a unique genomics target discovery platform [7][8] - The company has a pipeline of drug candidates in various stages of development, including treatments for HCM, neuropathic pain, obesity, and metabolic disorders [8]