Overview

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