HAYWARD, Calif., June 16 /PRNewswire/ -- Metabolex, Inc., a biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, announced today that it has completed enrollment in a 180-patient Phase 2 trial of MBX-8025 in overweight or obese patients with high cholesterol and triglycerides.
The randomized, double-blind study is designed to assess the drug's effect on dyslipidemia and insulin resistance, and will evaluate two different doses of MBX-8025 given over an 8-week period, both alone and in combination with Lipitor(R) (atorvastatin). The primary endpoint is the reduction in Apo B-100, the atherogenic lipoprotein in LDL (low-density lipoprotein), compared to placebo. Secondary endpoints include measurements of the effect of treatment on LDL, HDL (high-density lipoprotein), triglycerides and body weight and composition. Metabolic parameters, including glucose and insulin levels and insulin sensitivity, are also being assessed.
"America is suffering from an epidemic of obesity and its consequences, one of which is mixed dyslipidemia. Patients with this type of dyslipidemia have elevated LDL cholesterol, but also have elevated triglycerides, low HDL levels, and have a large amount of small, dense LDL particles, which are much more atherogenic," said David B. Karpf, M.D., the chief medical officer of Metabolex. "Statins do a good job of lowering LDL, but are not fully effective because they do not treat the other aspects of mixed dyslipidemia. This enrollment milestone puts us one step closer to understanding the ability of MBX-8025 to treat mixed dyslipidemia, as well as providing preliminary evidence of the drug's ability to enhance insulin sensitivity and reduce body weight -- two additional features of metabolic syndrome."
A growing body of research indicates that cardiac risk is affected by a
number of different compounds in the blood,
|SOURCE Metabolex, Inc.|
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