International biopharmaceutical company AstraZeneca has announced the launch of a local Phase II clinical trial (CT) in Russia, named LAZURE. The study will evaluate the efficacy and safety of the oral PCSK9 inhibitor AZD0780 in combination with rosuvastatin in patients with dyslipidemia. As noted by the company, only injectable PCSK9 inhibitors are currently available on the Russian and global markets, while oral formulations are not yet available.
AZD0780 is a small-molecule oral PCSK9 inhibitor. The PCSK9 enzyme promotes the degradation of LDL receptors; reducing its activity increases the number of these receptors and lowers plasma levels of “bad” cholesterol. The LAZURE study is a randomized, double-blind, placebo-controlled Phase II trial conducted in parallel groups.
The study aims to assess the effect of the combination of AZD0780 and rosuvastatin on low-density lipoprotein cholesterol levels in patients with dyslipidemia. It will involve eight medical centers across five regions of Russia, including Moscow, St. Petersburg, Ivanovo and Sverdlovsk regions, as well as Perm Krai.
The company expressed hope that the study results will help expand treatment options for patients with atherosclerotic cardiovascular disease.
Dyslipidemia is a lipid metabolism disorder characterized by elevated levels of low-density lipoprotein cholesterol, total cholesterol, triglycerides, and/or reduced high-density lipoprotein cholesterol. This condition is one of the major risk factors for the development of atherosclerosis and atherosclerotic cardiovascular diseases, including myocardial infarction and stroke.
