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Effect of Semaglutide 2.4 mg once-weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction, and type 2 diabetes

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Trial Profile

Effect of Semaglutide 2.4 mg once-weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction, and type 2 diabetes

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2024

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At a glance

  • Drugs Semaglutide (Primary)
  • Indications Heart failure; Obesity; Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms STEP HFpEF DM
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 07 Apr 2024 Results of prespecified pooled analysis of the STEP-HFpEF (n=529; Between March 19, 2021 and March 9, 2022) and STEP-HFpEF DM (n=616; between June 27, 2021 and Sept 2, 2022) trials, assessing the effects of semaglutide across a broad range of outcomes in people with obesity-related heart failure with preserved ejection fraction with and without diabetes, and to assess whether these effects are consistent across key patient subgroups published in the Lancet
    • 30 Oct 2023 Status changed from recruiting to completed.
    • 25 Aug 2023 According to a Novo Nordisk media release, this trial is to be included in the regulatory submission and expects to file for approval of Wegovy label update in the US and EU in the first half of 2024. This trial is expected to complete in Q4 2023, and subject to positive outcomes.
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