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A Phase 3, Multi-center, Placebo-controlled, Randomized, Double-blind 26-week Study to Assess the Safety and Efficacy of CaPre in Patients With Severe Hypertriglyceridemia

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Trial Profile

A Phase 3, Multi-center, Placebo-controlled, Randomized, Double-blind 26-week Study to Assess the Safety and Efficacy of CaPre in Patients With Severe Hypertriglyceridemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Omega-3 phospholipid (Primary)
  • Indications Hyperlipidaemia; Hypertriglyceridaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms TRILOGY 1
  • Sponsors Acasti Pharma

    • Most Recent Events

    • 31 Aug 2020 According to an Acasti Pharma media release, the company plans to pool together the results from the two studies (Trilogy 1 & 2) to better understand this phenomenon in post-hoc explorations.
    • 31 Aug 2020 According to an Acasti Pharma media release, the company has decided not file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for patients with severe hypertriglyceridemia, and does not plan to conduct additional clinical trials for CaPre.
    • 31 Jul 2020 According to an Acasti Pharma media release, the key secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY 2 trials, and pooled results from both studies, are still expected within several weeks following the unblinding of TRILOGY 2 results.

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