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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in symptomATic Obstructive And Non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)

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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in symptomATic Obstructive And Non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Apr 2025

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At a glance

  • Drugs Sotagliflozin (Primary)
  • Indications Hypertrophic cardiomyopathy
  • Focus Registrational; Therapeutic Use
  • Acronyms SONATA-HCM
  • Sponsors Lexicon Pharmaceuticals

    • Most Recent Events

    • 06 Mar 2025 According to a Lexicon Pharmaceuticals media release, enrollment is underway and site initiation in the European Union and Latin America countries are well underway to further support the company's trial execution timelines. All target sites are expected to be up and running by Q3.
    • 27 Sep 2024 According to a Lexicon Pharmaceuticals media release, Based on company's interactions with FDA, and if supported by positive study results, company plans to submit a supplemental new drug application (sNDA) with a broad proposed label to improve symptoms and physical limitations in adults with HCM.
    • 27 Sep 2024 According to a Lexicon Pharmaceuticals media release, company plans to conduct this multinational study at 130 sites in 20 countries and enroll adults aged 18 years or older diagnosed with symptomatic HCM, either obstructive (oHCM) or non-obstructive (nHCM). Initial study sites have been activated and patient randomization is underway.

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