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 eight-week period, both alone and in combination with Lipitor (atorvastatin).
The primary endpoint is the reduction in Apo B-100, the atherogenic lipoprotein in low-density lipoprotein (LDL), compared to placebo. Secondary endpoints include measurements of the effect of treatment on LDL, high-density lipoprotein (HDL), triglycerides and body weight and composition. Metabolic parameters, including glucose and insulin levels and insulin sensitivity, are also being assessed.
David Karpf, chief medical officer of Metabolex, said: “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.”