Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Adults

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy of a multifactorial approach associated with orlistat (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination with diet, physical activity, and/or cognitive behavioral therapy will be monitored.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Orlistat

Criteria

Inclusion Criteria:

• Body mass index (BMI) greater than or equal to (>/=) 30 kilograms per meter-squared (kg/m^2), or BMI >/= 28 kg/m^2 with risk factors of diabetes, hypertension, or hyperlipidemia, before weight loss

• Documented weight loss >/= 10% of initial body weight obtained with diet, with or without psychological therapy or orlistat

Exclusion Criteria:

• Pregnant or lactating females

• History or presence of significant medical disorders

• Active gastrointestinal disorders such as peptic ulcer disease or malabsorption syndromes

• Pancreatic disease: pancreatic enzyme deficiency, history or current presence of pancreatitis

• Clinically significant abnormal clinical chemistry or hematology results

• Excessive alcohol intake

• Smoking cessation within the previous 6 months

• History or presence of cancer

• Administration of medicines known to alter body weight

• History or presence of cancer