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Diseases of the Digestive System - Liver, Phase II

A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH (VOYAGE)

What is the purpose of this trial?

To evaluate the effects of VK2809 compared to placebo on liver fat content (assessed by MRI-PDFF, Magnetic Resonance Imaging- Proton Density Fat Fraction).

The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at Randomization and every four weeks from Week 4 through Week 52 and through End of Study period. The study includes a post-dosing study visit that will occur 4 weeks after the last dose of study drug. This visit represents the End-of-Study Visit (Week 56 Visit). Three hundred thirty-seven subjects will be enrolled into five treatment arms and there will be an equal distribution of males and females in each treatment arm. Subjects will be stratified by gender, fibrosis stage, and diabetes status.

  • Trial with
    Viking Therapeutics, Inc.
  • Ages
    18 years - 75 years
  • Gender
    Both

Contact Information

For more information about this study, including how to volunteer, contact Elizabeth Szymanski

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  • Last Updated
    11/05/2023
  • Study HIC
    #2000029514