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Completed

NCT Number: NCT02706067

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Xenical

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Mar 11, 2016
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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