Back to Results

Voyage Study

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
Therapeutic Area Non-Alcoholic steatohepatitis
Principal Investigator Raza Malik
Min Age 18 Years
Max Age 75 Years
Gender All
Contact Christina Picornell
617-636-0653
cpicornell@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04173065

Overview

The purpose of this study is to find out about the safety and efficacy of VK2809 for the treatment of non-alcoholic steatohepatitis (NASH).

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.