SAN DIEGO, July 9 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced positive results from a 28-week dose-ranging study of pramlintide/metreleptin, a combination treatment comprising pramlintide, an analog of the natural hormone amylin, and metreleptin, an analog of the natural hormone leptin, in overweight and obese patients. This Phase 2 study successfully characterized patients who responded best to treatment and also provided important information to inform dose selection.
At 28 weeks, evaluable patients with a starting body mass index (BMI) less than 35 kg/m2 (n=149), and treated with the highest pramlintide/metreleptin doses, experienced significantly more weight loss on average (11%; 22 pounds, p<0.01) than those receiving placebo (1.8%; 4 pounds) or either agent alone (approximately 5%; 10 pounds). Consistent with the physiologic role of leptin in regulating body fat, the weight loss in these patients was predominantly due to a reduction in fat mass (approximately 18 of the 22 pounds lost). These study results confirm previous Phase 2 results with this combination therapy and provide a solid foundation for the Company's ongoing obesity development program.
In the overall evaluable study population, all of the pramlintide/metreleptin combination arms achieved more weight loss than placebo. The magnitude of weight loss was found to be dependent on dosage and baseline BMI. In a pre-specified analysis of evaluable patients with a starting BMI less than 35 kg/m2, weight loss with pramlintide/metreleptin was more than additive compared to that with pramlintide and metreleptin alone, a finding that was not observed in the overall evaluable population.
"Despite their best efforts with diet and exercise alone, most overweight or obese individuals experience progressive weight
|SOURCE Amylin Pharmaceuticals, Inc.|
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