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news.Amylin Pharmaceuticals has initiated a Phase IIb clinical study evaluating various dosing combinations of pramlintide, an analog of the natural hormone amylin, and recombinant human leptin for the treatment of obesity.
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The objective of this dose-ranging study is to support dose selection for Phase III, and to inform the ongoing development of a convenient delivery system for this combination regimen. The six-month, randomized, double-blind, placebo-controlled multi-center study will enroll approximately 600 overweight and obese subjects and is expected to complete in mid-2009.
The study will include a broad range of overweight and obese subjects (body mass index 27 to 45 kg/m2) and will compare various pramlintide/metreleptin combination regimens with each compound alone and with placebo.
Christian Weyer, vice president of clinical research, Amylin, said: “Building upon the positive results of our translational research program published in Proceedings of the National Academy of Sciences (PNAS), and the extensive clinical experience with both pramlintide and metreleptin as monotherapies, the newly initiated Phase IIb study will bring us one step closer to our goal of offering obese individuals a safe and effective therapy that results in meaningful weight loss.”