Assessing the effect of ultra-small phospholipid nanoparticles on biochemical parameters of carbohydrate and fat metabolism in patients with combined hyperlipidemia

Abstract Background and aims Based on the developed technology of preparation of ultra-small size phospholipid (PL) nanoparticles without the use of detergents/surfactants and stabilizers drug preparation, exhibiting hypolipidemic properties has been obtained. Preclinical and clinical studies have shown that phospholipid nanoparticles of 20–30 nm (PLN) have activated reverse cholesterol transport and reduced non-high-density lipoprotein cholesterol levels. The aim of the study was to compare the effect of PLN relative to placebo on the selected parameters of carbohydrate and fat metabolism in patients with combined hyperlipidemia. Methods This Phase III, randomized, double-blind, placebo-controlled, parallel-group study was conducted at 4 centers. The patients (pts) received PLN or placebo (1:1), powder for oral solution preparation (500 mg PL/dose) orally 2 times per day for 12 weeks. Biochemical parameters of carbohydrate and fat metabolism were measured. The data is presented in M (s). Statistical analysis was performed using the Mann-Whitney U-test and the Wilcoxon sign rank test. P-value