A double-blind, placebo-controlled trial of exenatide for the treatment of olanzapine-related weight gain in obese and overweight adults.

OBJECTIVE: To assess the safety and efficacy of exenatide in overweight or obese patients treated with olanzapine. METHODS: Adults with stable major mood or psychotic disorders were randomized to double-blind exenatide or placebo for 16 weeks. Weight and body mass index (BMI) were monitored throughout the study. A secondary objective was to evaluate the tolerability of exenatide and its effects on mood and psychotic symptoms. RESULTS: A significant difference in weight change was detected between the treatment groups. Participants in the exenatide group experienced on average a minor weight loss, while participants in the placebo group on average experienced weight gain (-0.5 kg [-0.6 %] vs. +2.6 kg [+2.8 %], both p < .01). The most common side effects in the exenatide group were gastrointestinal symptoms and headaches. There were no clinically meaningful differences between the groups in changes to mood or psychotic symptoms. CONCLUSIONS: Exenatide is effective and well-tolerated for attenuating olanzapine-associated weight gain. CLINICAL TRIAL REGISTRATION INFORMATION: Exenatide for the Treatment of Weight Gain Associated with Olanzapine in Obese Adults. NCT00845507.