USA-based Amylin Pharmaceuticals says that results from a Phase II clinical study of its developmental obesity drug pramlintide demonstrate the compound's efficacy in terms of increased weight loss during treatment when compared with placebo. The compound, which is a synthetic analog of human amylin, is thought to play a role in the regulation of food and appetite, and is the active ingredient in the firm's diabetes product Symlin (pramlintide acetate).
The drug was assessed in a randomized, double-blind, placebo-controlled, dose-ranging study which enrolled 408 obese patients. All study subjects took part in a full structured lifestyle intervention program which included dietary advice, exercise and behavioral counselling. Following a one week lead in period, subjects were randomized to receive either pramlintide at one of six dosages or placebo, for 16 weeks.
Analysis of the data showed that average weight loss in the drug-treated groups ranged from 8.14 to 13.4 pounds versus an average loss of 6.2 pounds observed in subjects given placebo. The company added that the drug was also safe and well-tolerated, with 75% of those completing the program electing to continue receiving the drug in an extension to the study.
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