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
Phase of Trial: Phase II
Latest Information Update: 29 Nov 2019
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At a glance
- Drugs VK 2809 (Primary)
- Indications Non-alcoholic steatohepatitis
- Focus Therapeutic Use
- Acronyms VOYAGE
- Sponsors Viking Therapeutics
- 20 Nov 2019 Status changed from planning to recruiting.
- 19 Nov 2019 According to a Viking Therapeutics media release, the trial has received clearance for the first six months of dosing and, subject to submission and satisfactory regulatory review of data from recently completed 12-month toxicity studies, patients will continue to receive VK2809 for the planned 52-week treatment duration.
- 19 Nov 2019 According to a Viking Therapeutics media release, clinical trial sites are open for patient enrollment following clearance of the IND. The IND included results from the previously reported 12-week Phase 2 study of VK2809 in subjects with hypercholesterolemia and NAFLD, as well as prior Phase 1 single and multiple-ascending dose studies in healthy volunteers and subjects with mild hypercholesterolemia, respectively.