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Amylin Pharmaceuticals announced positive results, showing an average 22 pound weight loss from a 28-week study of pramlintide/leptin……
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.
Steven R. Smith, M.D., professor and assistant director of clinical research at the Pennington Biomedical Research Center, commented that, “Despite their best efforts with diet and exercise alone, most overweight or obese individuals experience progressive weight gain over time. To date, the only highly effective treatment option is surgical and limited to the minority of patients who have advanced to the most severe forms of obesity.”
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.
Lifestyle intervention was included throughout study (dietary, exercise and behavioral). Body composition was assessed at enrollment and again at study termination.