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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Orlistat

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Geneve, Switzerland, 1211

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Xenical

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 8, 2016
• First Posted (Estimate): March 11, 2016

Study Record Updates

• Last Update Posted (Estimate): April 5, 2016
• Last Update Submitted That Met QC Criteria: April 2, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents; Anti-Obesity Agents; Orlistat
• Other Study ID Numbers: ML16868