The purpose of this study is to find out about the safety and efficacy of VK2809 for the treatment of non-alcoholic steatohepatitis (NASH).
Voyage Study
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
Non-alcoholic steato-hepatitis or fatty liver disease
All genders
18-75
Recruiting now
Overview
Principal Investigator: Raza Malik
Contact Us
Christina Picornell
Study details
Inclusion Criteria
- Diagnosis of NASH
- Willing and able to undergo liver biopsies and MRI procedures
Exclusion Criteria
- Other co-existing liver diseases (HBV, HCV, PSC, PBC, AIH etc.)
- Excessive alcohol or drug consumption
- Actively enrolled in a weight loss program or taking medications to lose weight
Study Requirements
The Voyage study can last up to 15 months. This study includes a 52 week, double-blind treatment period. You will have approximately 4 in 5 chance of being assigned to VK2809 (study drug), and approximately 1 in 5 chance of getting placebo. This study will have 16 scheduled study visits over a period of 64 weeks. 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. During the study, you may have 1-2 Liver Biopsies and 3 MRI scans done. The study assessments will also include, reviewing your medical history, collecting blood/urine samples to monitor your health, 12-lead EGG, 24 hour Holter monitoring, physical exams, and answering study related questions about your health and lifestyle.