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Essentialis Completes Patient Enrollment in Phase 2 Trial of DDCR for Treatment of Dyslipidemia
Date:11/23/2008

CARLSBAD, Calif., Nov. 23 /PRNewswire/ -- Essentialis Inc, a clinical stage pharmaceutical company, announced today that it has completed enrollment in a 92-patient Phase 2 trial of DCCR in dyslipidemic patients. 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 DCCR given over an 8-week period. Randomization was stratified by Body Mass Index (BMI) and concurrent use of statin drugs. The endpoints of the study include measurements of the effect of treatment on triglycerides, total-cholesterol, LDL-cholesterol, 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 30th, 2009. Top-line results are anticipated in late March, 2009.

Commenting on this milestone achievement, Essentialis President and CEO, Iain Dukes 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."

About DCCR

DCCR, diazoxide choline controlled release, is an ATP-dependent potassium channel agonist with potential utility in several cardiovascular and metabolic diseases. Extensive Phase 1 testing and investigator-sponsored clinical studies have demonstrated the drug's potential to lower triglycerides, non-HDL cholesterol and LDL-cholesterol while raising HDL-cholest
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SOURCE Essentialis Inc
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