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
More Information


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.