Initially, weight loss was induced by an
8-week VLED (600–800 kcal/day) in 383 patients with a mean BMI of 37.5 kg/m2
(range
30.0–45.2). Those who lost 5% of their body weight (309 of 383 patients) were then ran-
domized to receive lifestyle counseling for 3 years together with either orlistat 120 mg t.i.d. or
matching placebo capsules. Primary end points were the maintenance of 5% weight loss after
3 years. Additionally, differences in the development of type 2 diabetes between orlistat and
placebo were analyzed