Progressive reduction in body weight after treatment with the amylin analog pramlintide in obese subjects : A phase 2, randomized, placebo-controlled, dose-escalation study

Context: In previous 1-yr trials, treatment with pramlintide (120 μg), an analog of the β-cell hormone amylin, induced sustained reductions in A1C and body weight in insulin-using subjects with type 2 diabetes. Objective: To assess the potential of pramlintide as an antiobesity agent, we assessed the weight effect, safety, and tolerability of pramlintide in non-insulin-treated obese subjects with and without type 2 diabetes at doses greater than previously studied. Design/Setting: We performed a randomized, double-blind, placebo-controlled, multicenter study. Patients: A total of 204 obese subjects [80/20% female/male, age 48 ± 10 yr, and body mass index 37.8 ± 5.6 kg/m2 (mean ± sd)] participated in the study. Intervention: For 16 wk, without concomitant lifestyle intervention, subjects self-administered pramlintide (nonforced dose escalation ≤ 240 μg) or placebo via sc injection three times a day before meals. Main Outcome Measures: Weight, waist circumference, tolerability, and safety were the main outc...