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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Drug: Orlistat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orlistat<br>Participants will receive intermittent orlistat for up to 4 years, with the dose determined according to body weight changes. | Drug: Orlistat<br>* Participants will receive orlistat on an intermittent basis as 120 milligrams (mg) three times a day: once with breakfast, once with lunch, and once with dinner. In case of weight relapse (increase 2.5 percent [%] or more from Baseline) orlistat will be administered for up to 2 months or until weight regain reaches 0% from Baseline. For special occasions (feasts, birthdays, anniversaries) orlistat will be given for up to 3 days.<br>* Other names: Xenical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change from Baseline in Body Weight at Year 2 |  | Baseline and Year 2 | 
| Percent Change from Baseline in Body Weight at Year 4 |  | Baseline and Year 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Diagnosed with Binge Eating Disorder According to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Criteria |  | Every 6 months during Year 1, annually during Years 2 to 4 | 
| Eating Disorder Inventory (EDI) 2 Subscale and Total Score |  | Baseline and Year 4 | 
| Hospital Anxiety and Depression (HAD) Subscale Score |  | Baseline and Year 4 | 
| Number of Orlistat Capsules Taken During the Study |  | Given up to three times per day for 4 years | 
| Duration of Orlistat Treatment During the Study |  | Given up to three times per day for 4 years | 
| Waist-to-Hip Circumference Ratio |  | Baseline and Year 4 | 
| Waist, Hip, Wrist, and Arm Circumference (Expressed in Centimeters) |  | Baseline and Year 4 | 
| Skinfold Thickness (Expressed in Millimeters) |  | Baseline and Year 4 | 
| Bioelectrical Impedance (Expressed in Kilograms of Body Fat Mass) |  | Baseline and Year 4 | 
| Number of Kilocalories Expended, Total and at Rest |  | Baseline and Year 4 |