A Study of Xenical (Orlistat) in Overweight and Obese Adolescents

Open-label Comparative Randomized Study of the Efficacy and Safety of Orlistat (Xenical) in Complex Therapy of Obesity and Metabolic Disorders in Adolescents

This 2 arm study will assess the effect of Xenical on body mass index (BMI)in obese or overweight adolescents. Patients will be randomised into one of 2 groups; both groups will undergo a regimen of mildly hypocaloric diet and physical exercise, but one group will also receive Xenical 120mg po tid. The anticipated time on study treatment is 1 year, and the target sample size is <100 individuals.

Inclusion Criteria:

• adolescent patients, 12-14 years of age
• overweight or obese

Exclusion Criteria:

• age <12 or >14 years
• BMI in normal range