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

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease
Clinical Trial Details
NCT number NCT04173065
Study type Interventional
Source Viking Therapeutics, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 15, 2019
Completion date June 2024
View Details
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