A Phase 3, Double-blind/double-dummy, Safety/efficacy/superiority of Sibutramine/topiramate XR in Adults with Overweight

A phase 3, multicenter, randomized, double-blind, double-dummy, parallel-group, active-drug- and placebo-controlled clinical trial to assess the safety, efficacy and superiority of the new fixed-dose combination sibutramine IR/topyramat XR in weight reduction in overweight adults with comorbidity(ies) or obesity

A phase 3, multicenter, national, randomized, double-blind, double-dummy, parallel-group, active-drug and placebo-controlled, superiority clinical trial. Individuals of both sexes aged ≥18 years and ≤60 years, overweight (BMI ≥ 27kg/m2) in the presence of comorbidities (dyslipidemia, systemic arterial hypertension \[SAH\], pre-diabetes and/or sleep apnea) or obese (BMI ≥ 30kg/m2 and \< 45kg/m2).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female volunteers aged between 18 and 60 years (inclusive);
2. 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);
3. Women of childbearing age must use adequate contraceptive methods;
4. Volunteers willing and able to comply with all aspects of the protocol;
5. Signing the Informed Consent Form (ICF) before performing any study procedure.

Exclusion Criteria:

1. Participation in a lifestyle change program within the three months prior to the start of the study;
2. 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;
3. 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).
4. Presence of diabetes mellitus;
5. History of coronary artery disease (angina, history of myocardial infarction);
6. Congestive heart failure;
7. History of tachycardia;
8. History of peripheral obstructive arterial disease;
9. History of arrhythmia;
10. History of cerebrovascular disease (stroke or transient ischemic attack);
11. Inadequately controlled systemic arterial hypertension (\> 145/90 mmHg);
12. History or active pulmonary arterial hypertension;
13. History or presence of eating disorders such as bulimia and anorexia;
14. Moderate or severe renal impairment (estimated creatinine clearance \< 70 mL/min);
15. Hepatic failure Child-Pugh categories B or C (Child-Pugh scale score ≥ 7 points);
16. Current use of monoamine oxidase inhibitors (MAOIs) or any other drug treatment for psychiatric disorders;
17. History of psychiatric disorder requiring previous drug treatment;
18. Glaucoma or high intraocular pressure;
19. Unstable thyroid disease or replacement therapy;
20. Hypersensitivity to sibutramine, topiramate, or to any component of the investigational product formulation;
21. Known hypersensitivity to any component of the investigational drug formulation;
22. Urinary lithiasis;
23. Pregnancy or lactation;
24. 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.