A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH (VOYAGE)
Diseases of the Digestive System - Liver
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.
- Ages18 years - 75 years
- Trial withViking Therapeutics, Inc.
- Start Date07/19/2021
- End Date03/31/2021
- Last Updated07/26/2021
- Study HIC#2000029514