The multi-centre placebo-controlled randomised double-blind 12-week study is enrolling patients with severe hypertriglyceridemia, more commonly known as very high triglycerides, or VHTG.
The study, which will be conducted by Amarin's China partner Eddingpharm, will assess the primary percentage change in triglyceride levels from baseline compared to placebo after 12 weeks of treatment.
Eddingpharm anticipates that the study will be completed within the next two years.
"This clinical trial puts Vascepa on track to be the first ever pure prescription-grade EPA based drug product in China. The parties believe the commercial opportunity in China is largely based on the prevalence of hypertriglyceridemia, which is estimated to affect around 17.7% of the adult Chinese population, about 185 million people," said Amarin.
Previous findings
The study is similar to Amarin's MARINE trial, which it published in 2010.
Itreported that Vascepa in 4g/day doses significantly lowered triglycerides by 33% compared to placebo, without increasing LDL cholesterol (non-significant decrease of 2% versus placebo).
In addition, Vascepa demonstrated a statistically significant decrease compared to placebo in multiple other important lipid biomarkers in MARINE, including non-HDL cholesterol, apolipoprotein B (apo B), lipoprotein-phospholipase A2 (Lp-PLA2), very low-density lipoprotein cholesterol (VLDL-C), total cholesterol (TC), and the inflammatory marker, high-sensitivity C-reactive protein (hsCRP).