Phase 2 Trial Shows Positive Results for Weight-loss Drug

Pharmacy Times, Volume 0, 0

The results of a phase 2 trial of pramlintide(Symlin), manufactured by AmylinPharmaceuticals, in obese patientsshowed progressive weight loss over 16weeks. The randomized, double-blind,placebo-controlled, dose-ranging studyof 408 obese patients included a structuredlifestyle intervention program,including diet, exercise, and behavioralcounseling. After a 1-week placebo leadin,patients were randomly assigned toreceive either placebo or pramlintide—120, 240, or 360 μg administered 2 or 3times a day before meals. The averageweight loss in the pramlintide groupsranged from 8.4 to 13.4 lb, comparedwith 6.2 lb in the placebo group. Both bidand tid regimens were shown to beeffective. The drug also was well-tolerated,as approximately 75% of the studyparticipants decided to continue usingthe medication in an ongoing study.Pramlintide is a synthetic analogue of ahuman hormone that has a part in regulatingappetite and food intake. It also isan active ingredient in Symlin, part of anew class of injected antihyperglycemicmedications for patients with type 2 ortype 1 diabetes.

Ms. Farley is a freelance medicalwriter based in Wakefield, RI.