A Phase 3, Double-blind/Double-dummy, Safety/Efficacy/Superiority of Sibutramine/Topiramate XR in Adults With Overweight

Who can take part

• Male or female volunteers aged between 18 and 60 years (inclusive)
• BMI ≥ 27kg/m2 and < 45kg/m2. Patients with a BMI ≥ 27kg/m2 and < 30kg/m2 must have at least one of the following comorbidities to be included in the study: dyslipidemia, systemic arterial hypertension (SAH), pre-diabetes (fasting glucose ≥ 100mg/dL and < 126 mg/dL and/or HbA1c ≥ 5.7% and < 6.5%] and/or sleep apnea (confirmed by polysomnography performed up to three months before enrollment in the study)
• Women of childbearing age must use adequate contraceptive methods
• Volunteers willing and able to comply with all aspects of the protocol
• Signing the Informed Consent Form (ICF) before performing any study procedure

Who cannot take part

• Participation in a lifestyle change program within the three months prior to the start of the study
• Treatment with drugs (prescription or over-the-counter) or alternative drugs intended to promote weight loss within the three months prior to the start of the study. These medications include, among others: liraglutide, orlistat, sibutramine, topiramate, naltrexone, bupropion, sertraline, fluoxetine, duloxetine. Note: The use of metformin or other hypoglycemic drugs prescribed for the treatment of polycystic ovary syndrome or prevention of diabetes is not permitted
• Treatment with drugs known to cause significant weight gain within three months of starting the study. These medications include, among others: corticosteroids, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, lithium)
• History of psychiatric disorder requiring previous drug treatment
• Hypersensitivity to sibutramine, topiramate, or to any component of the investigational product formulation
• Known hypersensitivity to any component of the investigational drug formulation
• Presence of diabetes mellitus
• History of coronary artery disease (angina, history of myocardial infarction)
• Congestive heart failure
• History of tachycardia
• History of peripheral obstructive arterial disease
• History of arrhythmia
• History of cerebrovascular disease (stroke or transient ischemic attack)
• Inadequately controlled systemic arterial hypertension (> 145/90 mmHg)
• History or active pulmonary arterial hypertension
• History or presence of eating disorders such as bulimia and anorexia
• Hepatic failure Child-Pugh categories B or C (Child-Pugh scale score ≥ 7 points)
• Current use of monoamine oxidase inhibitors (MAOIs) or any other drug treatment for psychiatric disorders
• Unstable thyroid disease or replacement therapy
• Moderate or severe renal impairment (estimated creatinine clearance < 70 mL/min)
• Any medical or other condition that, in the opinion of the investigator(s), prevents the participant from participating in the clinical trial, such as significantly abnormal laboratory results or any physical or mental condition that prevents compliance with the protocol
• Glaucoma or high intraocular pressure
• Urinary lithiasis
• Pregnancy or lactation