Essentialis completes enrollment in Phase II dyslipidemia trial

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.”