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The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia

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Trial Profile

The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Apr 2022

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At a glance

  • Drugs Volanesorsen (Primary)
  • Indications Hyperlipoproteinaemia type I; Hypertriglyceridaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms COMPASS
  • Sponsors Ionis Pharmaceuticals

Most Recent Events

  • 23 Aug 2021 According to a PTC Therapeutics media release, Brazilian Health Regulatory Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria), has approved Waylivra (volanesorsen) as the first treatment for familial chylomicronemia syndrome (FCS) in Brazil. This approval is based on results from the Phase 3 APPROACH study and the APPROACH Open Label Extension study and is supported by results from the Phase 3 COMPASS study.
  • 06 May 2020 According to an Ionis Pharmaceuticals media release, the company plans to refile the WAYLIVRA U.S. NDA and report additional proof-of-concept data from their several programs in 2020.
  • 08 May 2019 According to an Akcea Therapeutics media release, top-line results from this study is expected in middle of 2019.

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