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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02706067
Recruitment Status : Completed
First Posted : March 11, 2016
Last Update Posted : April 5, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Orlistat Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Patients
Study Start Date : July 2002
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat

Arm Intervention/treatment
Experimental: Orlistat
Participants will receive intermittent orlistat for up to 4 years, with the dose determined according to body weight changes.
Drug: Orlistat
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.
Other Name: Xenical

Primary Outcome Measures :
  1. Percent Change from Baseline in Body Weight at Year 2 [ Time Frame: Baseline and Year 2 ]
  2. Percent Change from Baseline in Body Weight at Year 4 [ Time Frame: Baseline and Year 4 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Eating Disorder Inventory (EDI) 2 Subscale and Total Score [ Time Frame: Baseline and Year 4 ]
  3. Hospital Anxiety and Depression (HAD) Subscale Score [ Time Frame: Baseline and Year 4 ]
  4. Number of Orlistat Capsules Taken During the Study [ Time Frame: Given up to three times per day for 4 years ]
  5. Duration of Orlistat Treatment During the Study [ Time Frame: Given up to three times per day for 4 years ]
  6. Waist-to-Hip Circumference Ratio [ Time Frame: Baseline and Year 4 ]
  7. Waist, Hip, Wrist, and Arm Circumference (Expressed in Centimeters) [ Time Frame: Baseline and Year 4 ]
  8. Skinfold Thickness (Expressed in Millimeters) [ Time Frame: Baseline and Year 4 ]
  9. Bioelectrical Impedance (Expressed in Kilograms of Body Fat Mass) [ Time Frame: Baseline and Year 4 ]
  10. Number of Kilocalories Expended, Total and at Rest [ Time Frame: Baseline and Year 4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02706067

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Geneve, Switzerland, 1211
Sponsors and Collaborators
Hoffmann-La Roche
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT02706067     History of Changes
Other Study ID Numbers: ML16868
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents