A Phase 3, Double-blind/Double-dummy, Safety/Efficacy/Superiority of Sibutramine/Topiramate XR in… (NCT05209984) | Clinical Trial Compass
WithdrawnPhase 3
A Phase 3, Double-blind/Double-dummy, Safety/Efficacy/Superiority of Sibutramine/Topiramate XR in Adults With Overweight
Stopped: Strategic change in development priorities
Brazil0Started 2026-04
Plain-language summary
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
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).