Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults

EMS

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Other: Placebo; Drug: Orlistat 60 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01755676

ORL60EMS0511

Details and patient eligibility

About

The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of Obesity in adults.

Enrollment: 638 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed Informed Consent;
• Adults Male and Female ≥ 18 years old;
• Obesity (BMI ≥ 30kg/m2 or ≥ 27 Kg/m2 with associate risk);

Exclusion criteria

• Pregnancy and Lactation or women without effective contraception;
• Relevant clinical diseases;
• Obesity associated to genetic syndrome;
• Decompensated Diabetes;
• Psychiatric disorders;
• Alimentary disorders;
• Use of: anorectics, herbal weight loss and/or constipation and laxatives, in the past 30 days;
• Patients using cyclosporine or amiodarone;
• Patients with bowel disease;
• Prior bariatric surgery;
• Anemia;
• Hemoglobinopathies and coagulopathy;
• History of cancer in the past five years;
• Use of corticosteroids, oral or injectable, in the last 30 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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638 participants in 2 patient groups, including a placebo group

Orlistat 60 mg

Experimental group

Treatment:

Drug: Orlistat 60 mg

Placebo

Placebo Comparator group

Treatment:

Other: Placebo