This 2-year, multicenter, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of orlistat (120 mg three times daily) in 743 obese patients (BMI 28–47 kg/m²) across 15 European centers. Following a 4-week lead-in period with a hypocaloric diet, 688 participants were randomized to receive orlistat or placebo alongside dietary