The combination therapy was well tolerated, and no cardiovascular or neuropsychiatric (such as anxiety or depression) safety signals were observed. Consistent with previous clinical experience, the most common side effects seen with pramlintide/metreleptin combination treatment were injection site adverse events and nausea, which were mostly mild or moderate and transient in nature.
"These findings provide us with valuable data that will inform our clinical and product development strategy moving forward," said Christian Weyer, M.D., vice president, corporate development, diabetes and obesity at Amylin Pharmaceuticals. "Our integrated neurohormonal approach to obesity provides a broad research and development platform that has the potential to yield transformational therapies that address a range of unmet patient needs across the various classes of obesity."
This Phase 2, 28-week, double-blind, placebo-controlled multi-center study randomized 608 obese or overweight patients with a BMI ranging from 27-45 kg/m2. Patients were well-distributed across this BMI range, with approximately 40% of patients at a starting BMI less than 35 kg/m2. Following a one-week placebo lead-in period, study subjects were randomized in a balanced fashion to receive twice-daily therapy with one of the following eight treatment regimens: 1) placebo/placebo; 2) pramlintide 360 mcg/placebo; 3)
|SOURCE Amylin Pharmaceuticals, Inc.|
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