Regeneron Pharmaceuticals Inc announced initial results of its Phase II study evaluating Axokine for weight loss in overweight and obese people with type 2 diabetes at doses of 1.0 microgram per kilogram (mcg/kg) and 0.5 mcg/kg per day. The study showed that 12 weeks of treatment with Axokine resulted in statistically significant and dose-dependent weight loss.
Subjects who were treated with Axokine (1.0 mcg/kg/day) and dietary counseling lost 6.5 pounds on average, while those treated with placebo and dietary counseling lost only 2.5 pounds (p(less than).01). Trends towards improvements in blood glucose and other metabolic parameters were also observed during this small, short-term study. Axokine was generally well-tolerated with no Axokine-related serious adverse events. The 1.0 mcg/kg dose is being studied in the ongoing Phase III Axokine program, which thus far has included over 2,500 overweight and obese non-diabetic subjects. Approximately 90 percent of study participants completed the 12-week study.
"Overweight and obesity are major contributing factors for 80% of the 16 million Americans with type 2 diabetes, and weight loss is a cornerstone of both preventing and treating this serious disease," said Hans-Peter Guler, Vice President of Clinical Sciences for Regeneron. "Moreover, several studies have shown that weight loss in people with diabetes is often more difficult to achieve than weight loss in non-diabetic individuals."