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A Phase 3, Placebo-Controlled, Randomized, Double-blind, Parallel-arm Trial to Assess the Safety and Efficacy of MAT9001 in Subjects With Severe Hypertriglyceridemia: The AMPLIFY Trial

Trial Profile

A Phase 3, Placebo-Controlled, Randomized, Double-blind, Parallel-arm Trial to Assess the Safety and Efficacy of MAT9001 in Subjects With Severe Hypertriglyceridemia: The AMPLIFY Trial

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 04 Jan 2021

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At a glance

  • Drugs Ethyl eicosapentaenoic acid (Primary)
  • Indications Hypertriglyceridaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms AMPLIFY
  • Sponsors Matinas BioPharma
  • Most Recent Events

    • 04 Jan 2021 According to Matinas BioPharma media release, the company expect to initiate this study in the second half of 2021.
    • 15 Sep 2020 According to Matinas BioPharma media release, the company is evaluating several ways to both meet these requirements and to potentially provide additional data differentiating MAT9001 from other prescription omega-3 drugs.
    • 15 Sep 2020 According to Matinas BioPharma media release, the company and FDA The Company and the FDA agreed on key elements of the Phase 3 program to support a New Drug Application (NDA) filing, including the requirement for a single 12-week study to support efficacy in SHTG and FDA provided flexibility to Matinas in the totality of patient safety data needed to meet regulatory requirements for NDA submission.
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