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

NCT02706067 | Completed Phase 4

• 1 other identifier: ML16868
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

Study Arms (1)

Orlistat

EXPERIMENTAL

Participants will receive intermittent orlistat for up to 4 years, with the dose determined according to body weight changes.

Drug: Orlistat

Interventions

Orlistat DRUG

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.

Also known as: Xenical

Orlistat

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Obesity

Interventions

Orlistat

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 11, 2016
• Study Start: July 1, 2002
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

CH (1)