Clinical trial NCT02706067: Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Adults
Official title: Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent Change from Baseline in Body Weight at Year 2
timeFrame: Baseline and Year 2
measure: Percent Change from Baseline in Body Weight at Year 4
timeFrame: Baseline and Year 4
Secondary outcomes:
measure: Percentage of Participants Diagnosed with Binge Eating Disorder According to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Criteria
timeFrame: Every 6 months during Year 1, annually during Years 2 to 4
measure: Eating Disorder Inventory (EDI) 2 Subscale and Total Score
timeFrame: Baseline and Year 4
measure: Hospital Anxiety and Depression (HAD) Subscale Score
timeFrame: Baseline and Year 4
measure: Number of Orlistat Capsules Taken During the Study
timeFrame: Given up to three times per day for 4 years
measure: Duration of Orlistat Treatment During the Study
timeFrame: Given up to three times per day for 4 years
measure: Waist-to-Hip Circumference Ratio
timeFrame: Baseline and Year 4
measure: Waist, Hip, Wrist, and Arm Circumference (Expressed in Centimeters)
timeFrame: Baseline and Year 4
measure: Skinfold Thickness (Expressed in Millimeters)
timeFrame: Baseline and Year 4
measure: Bioelectrical Impedance (Expressed in Kilograms of Body Fat Mass)
timeFrame: Baseline and Year 4
measure: Number of Kilocalories Expended, Total and at Rest
timeFrame: Baseline and Year 4
Other outcomes:
Locations:
city: Geneve
country: Switzerland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: