Phase 2 Trial Shows Positive Results for Weight-loss Drug

Susan Farley
Published Online: Saturday, April 1, 2006

The results of a phase 2 trial of pramlintide (Symlin), manufactured by Amylin Pharmaceuticals, in obese patients showed progressive weight loss over 16 weeks. The randomized, double-blind, placebo-controlled, dose-ranging study of 408 obese patients included a structured lifestyle intervention program, including diet, exercise, and behavioral counseling. After a 1-week placebo leadin, patients were randomly assigned to receive either placebo or pramlintide— 120, 240, or 360 μg administered 2 or 3 times a day before meals. The average weight loss in the pramlintide groups ranged from 8.4 to 13.4 lb, compared with 6.2 lb in the placebo group. Both bid and tid regimens were shown to be effective. The drug also was well-tolerated, as approximately 75% of the study participants decided to continue using the medication in an ongoing study. Pramlintide is a synthetic analogue of a human hormone that has a part in regulating appetite and food intake. It also is an active ingredient in Symlin, part of a new class of injected antihyperglycemic medications for patients with type 2 or type 1 diabetes.

Ms. Farley is a freelance medical writer based in Wakefield, RI.

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