Contrave Has Positive Effect On Visceral Fat, Insulin Resistance
Data from a sub-study of its Phase IIb multi-center clinical trial of Contrave demonstrated robust improvements in both visceral fat and insulin resistance.
Contrave is a proprietary fixed dose combination of bupropion SR (sustained release) and Orexigen's novel formulation of naltrexone SR in a single tri-layer tablet. Contrave is designed to act on neurons in the brain with the goal of achieving appetite suppression, decreased food craving, and sustained weight loss.
Across the three Contrave arms, the mean reduction in visceral fat ranged from 13.7% to 16.7% after 24 weeks of treatment compared to a mean 4.6% reduction among the placebo group. Moreover, the effect of Contrave was substantially larger than that seen with either of Contrave's individual components when given alone. Visceral fat is located inside the abdominal cavity and surrounds vital organs such as the liver. Visceral fat accumulation, as opposed to subcutaneous fat which is found just underneath the skin, is associated with increased risk of heart disease and Type II diabetes.
Additional findings from this sub-study of 107 obese subjects revealed that Contrave improved measures of insulin resistance and demonstrated a positive impact on a number of other risk factors including triglycerides, cholesterol, and blood sugar. Together, such improvements hold potential for longer term health benefits.
"These clinical findings suggest the weight loss associated with Contrave also included a substantive loss in visceral fat. This is important for both patients and physicians because of the well-recognized link between visceral fat, diabetes and heart disease," said Gary Tollefson, M.D., Ph.D., Orexigen President and CEO. "We believe that Contrave may represent an important new weapon in the treatment of obesity, not only for the weight loss it appears to produce, but also for its potential impact on the behavioral and metabolic sequelae associated with obesity."
"The effect of Contrave on markers of insulin resistance is a novel observation that has potential to demonstrate a greater level of pharmacological synergy than had been anticipated," said Frank Greenway, M.D., Principal Investigator of the study and Professor and Chief of the outpatient department at the Pennington Biomedical Research Center in Baton Rouge. "In this study, the effect of Contrave on insulin resistance and other metabolic factors was superior to what was seen with placebo, bupropion, or naltrexone alone."
Contrave is now being studied in two separate multi-center Phase III studies, one of which is designed to assess its safety and efficacy in obese subjects with Type II diabetes.
Data on the effect of Contrave on visceral fat and insulin resistance will be presented at the ADA 67th Scientific Sessions on Saturday, June 23rd, 6:00- 7:15pm and Monday, June 25th, 12:00-2:00pm in Chicago (IL). Contrave data can be found in category 20B, poster number 45LB entitled, "Weight Loss with Bupropion and Naltrexone Improves Markers of Insulin-Resistance."