Obesity
Conditions
Brief 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.
Interventions
DRUGOrlistat
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Waist, Hip, Wrist, and Arm Circumference (Expressed in Centimeters) | Baseline and Year 4 |
| Eating Disorder Inventory (EDI) 2 Subscale and Total Score | Baseline and Year 4 |
Countries
Switzerland
Outcome results
None listed