Back to resultsMultifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Adults
Primary Purpose
Obesity
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Orlistat
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Orlistat
Arm Description
Participants will receive intermittent orlistat for up to 4 years, with the dose determined according to body weight changes.
Outcomes
Primary Outcome Measures
Percent Change from Baseline in Body Weight at Year 2
Percent Change from Baseline in Body Weight at Year 4
Secondary Outcome Measures
Percentage of Participants Diagnosed with Binge Eating Disorder According to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Criteria
Eating Disorder Inventory (EDI) 2 Subscale and Total Score
Hospital Anxiety and Depression (HAD) Subscale Score
Number of Orlistat Capsules Taken During the Study
Duration of Orlistat Treatment During the Study
Waist-to-Hip Circumference Ratio
Waist, Hip, Wrist, and Arm Circumference (Expressed in Centimeters)
Skinfold Thickness (Expressed in Millimeters)
Bioelectrical Impedance (Expressed in Kilograms of Body Fat Mass)
Number of Kilocalories Expended, Total and at Rest
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02706067
Brief Title
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
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orlistat
Arm Type
Experimental
Arm Description
Participants will receive intermittent orlistat for up to 4 years, with the dose determined according to body weight changes.
Intervention Type
Drug
Intervention Name(s)
Orlistat
Other Intervention Name(s)
Xenical
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change from Baseline in Body Weight at Year 2
Time Frame
Baseline and Year 2
Title
Percent Change from Baseline in Body Weight at Year 4
Time Frame
Baseline and Year 4
Secondary Outcome Measure Information:
Title
Percentage of Participants Diagnosed with Binge Eating Disorder According to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Criteria
Time Frame
Every 6 months during Year 1, annually during Years 2 to 4
Title
Eating Disorder Inventory (EDI) 2 Subscale and Total Score
Time Frame
Baseline and Year 4
Title
Hospital Anxiety and Depression (HAD) Subscale Score
Time Frame
Baseline and Year 4
Title
Number of Orlistat Capsules Taken During the Study
Time Frame
Given up to three times per day for 4 years
Title
Duration of Orlistat Treatment During the Study
Time Frame
Given up to three times per day for 4 years
Title
Waist-to-Hip Circumference Ratio
Time Frame
Baseline and Year 4
Title
Waist, Hip, Wrist, and Arm Circumference (Expressed in Centimeters)
Time Frame
Baseline and Year 4
Title
Skinfold Thickness (Expressed in Millimeters)
Time Frame
Baseline and Year 4
Title
Bioelectrical Impedance (Expressed in Kilograms of Body Fat Mass)
Time Frame
Baseline and Year 4
Title
Number of Kilocalories Expended, Total and at Rest
Time Frame
Baseline and Year 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Adults
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