Title: A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH (VOYAGE)
Associated condition: NASH
Status: Currently enrolling
Brief summary: This is a double-blind, placebo-controlled, randomized Phase 2 study in 337 subjects with biopsy-proven nonalcoholic steatohepatitis (NASH) and fibrosis.
Subjects will be randomized into five treatment arms with an equal distribution of men and women in each treatment arm. Subjects in each of the experimental arms will receive 1.0 mg VK2809, 2.5 mg VK2809, 5.0 mg VK2809, or 10.0 mg VK2809 in capsule form. Subjects in the placebo comparator group will receive matching placebos. Following 52 weeks of administration, subjects will undergo a 4-week off-drug phase.
Primary objectives: To assess the efficacy, safety, and tolerability of 52-week course of VK2809 followed by a 4-week off-drug phase in subjects with biopsy-proven NASH with fibrosis.
Estimated length of study: Primary outcome measures have an estimated time frame of 12 weeks with an estimated completion date of March 2021, while the time frame for secondary outcome measures is 52 weeks, with an estimated completion date of November 2021.
For more detailed information on this research trial, including eligibility and study design, please visit the clinical trial page at U.S. National Library of Medicine’s website. Note you can submit your information for consideration by submitting the contact form on this page.
