NASH - Nonalcoholic Steatohepatitis Clinical Trial
Official title:
VK2809 A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of VK2809 Administered for 52 Weeks Followed by a 4-Week Off-Drug Phase in Subjects With Biopsy Proven Non-Alcoholic Steatohepatitis With Fibrosis
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.
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