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Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes

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Trial Profile

Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Apr 2025

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At a glance

  • Drugs Semaglutide (Primary)
  • Indications Cardiovascular disorders; Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms SOUL
  • Sponsors Novo Nordisk

    • Most Recent Events

    • 30 Mar 2025 According to a Novo Nordisk media release, based on data from this study company has submitted a label extension application for Rybelsus, which has been accepted for review by the European Medicines Agency (EMA) and the US FDA. A decision is anticipated in 2025.
    • 29 Mar 2025 According to a Novo Nordisk media release, based on findings from this study , company submitted a label extension application for Rybelsus (semaglutide) tablets 14 mg for CV event risk reduction to the FDA.
    • 29 Mar 2025 Primary endpoint (Time to first occurrence of a major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death/non-fatal myocardial infarction/non-fatal stroke) has been met, According to Results presented in the Novo Nordisk media release.

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