Study Achieves Primary Endpoint, Demonstrating Statistically Significant Reductions in Liver Fat from Baseline to Week 12 in Patients Receiving VK2809 as Compared to Placebo
Up to 52% Mean Liver Fat Reduction Observed in VK2809-Treated Patients
Up to 85% of Patients Experienced at Least a 30% Relative Reduction in Liver Fat
Statistically Significant Reductions in LDL-C, Triglycerides, and Atherogenic Lipoproteins Observed
Adverse Events, Including GI-Related AEs, Similar Among VK2809-Treated Patients vs. Placebo
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SAN DIEGO, May 16, 2023 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced positive top-line results from its Phase 2b clinical trial of VK2809, the company's novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). The study successfully achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to Week 12 as compared with placebo. The median relative change from baseline in liver fat as assessed by magnetic resonance imaging, proton density fat fraction (MRI-PDFF) ranged from 38% to 55% for patients receiving VK2809. Additionally, VK2809-treated patients demonstrated statistically significant reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides, and atherogenic lipoproteins compared with placebo. The company expects to submit the results for presentation at a future medical conference.
Top-line study results include:
Primary Endpoint: Reduction in Liver Fat Content at 12 Weeks
Patients receiving VK2809 experienced statistically significant reductions in liver fat content, as assessed by MRI-PDFF, relative to placebo after 12 weeks of treatment. Importantly, up to 85% of patients receiving VK2809 experienced at least a 30% relative reduction in liver fat content, a level of reduction that is associated with greater likelihood of histologic response in NASH.
Placebo (n = 62) | VK2809 1 mg QD (n = 17)3,4 | VK2809 2.5 mg QD (n = 58) | VK2809 5 mg QOD (n = 36)4 | VK2809 10 mg QOD (n = 56) | |
Mean baseline liver fat content | 20.4 % | 21.7 % | 20.2 % | 18.4 % | 21.5 % |
Mean relative change in liver fat by MRI- PDFF1,2 | -3.7 % | -16.6% (p=0.082) | -45.3% (p |