The study encompasses both patients with very high triglycerides and mixed dyslipidemia and includes normal weight, overweight and obese patients presenting with or without hypertension.
The randomized, double-blind study is designed to assess the drug’s effect on dyslipidemia and will evaluate three different doses of diazoxide choline controlled release (DCCR) given over an eight-week period. Randomization was stratified by body mass index and concurrent use of statin drugs.
The endpoints of the study include measurements of the effect of treatment on triglycerides, total-cholesterol, low-density lipoprotein-cholesterol, high-density lipoprotein (HDL)-cholesterol and non-HDL-cholesterol, compared to placebo. The effects of DCCR on body weight, blood pressure and liver function tests compared to placebo are also being assessed.
A total of 16 patients have completed the study, and an additional 20 have completed the double-blind treatment phase. The last patient last visit is scheduled for January 30, 2009. Top-line results are anticipated in late March, 2009.
Iain Dukes, president and CEO of Essentialis, said: “Essentialis is now closer to understanding the ability of DCCR to treat both very high triglycerides and mixed dyslipidemia, delivering a competitive profile of across the board lipid improvements with the added potential benefit of weight loss.”