Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults

A Prospective Study, Parallel, Double-blind, Multicenter for Evaluation of Efficacy of Orlistat 60 mg as Adjuvant Treatment of Obesity in Adults

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Orlistat 60 mg; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 638
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil
      • Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
  • SP
    • Campinas, SP, Brazil, 13010001
      • Loema
  • São Paulo
    • Campinas, São Paulo, Brazil
      • Allergisa
    • Jau, São Paulo, Brazil
      • CIPMED
    • São José dos Campos, São Paulo, Brazil
      • Marcio Antonio Pereira Clinica de Endocrinologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; 1 tablet 3 times a day
Experimental: Orlistat 60 mg	Drug: Orlistat 60 mg; 1 tablet 3 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of Orlistat 60 mg associated with diet and exercise in relation to placebo associated with diet and exercise in obesity treatment based on weight loss.	112 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety will be evaluated by the adverse events occurrences	112 days

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 21, 2017

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 19, 2012
• First Posted (Estimate): December 24, 2012

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents; Anti-Obesity Agents; Orlistat
• Other Study ID Numbers: ORL60EMS0511

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No