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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease.

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Pemafibrate (Primary)
  • Indications Non-alcoholic fatty liver disease
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors Kowa

    • Most Recent Events

    • 26 Jun 2021 Primary endpoint (Efficacy: % Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)) has not been met, according to the result presented at The International Liver Congress 2021.
    • 26 Jun 2021 Results (n=58) assessing the efficacy and safety of pemafibrate in patients with non-alcoholic fatty disease, presented at The International Liver Congress 2021.
    • 08 Apr 2021 Status changed from active, no longer recruiting to completed.

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