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

Obesity Clinical Trial

Official title:
A Phase 3, Randomized, Double-blind, Double-dummy, Parallel-group, Active Drug and Placebo-controlled, Safety, Efficacy and Superiority of Sibutramine IR/Topiramate XR in Overweight Adults With Comorbidities/Obesity

Clinical Trial 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

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05209984
Study type Interventional
Source Eurofarma Laboratorios S.A.
Contact Edilene Macedo, Analyst
Phone 5511 5090-8422
Email edilene.macedo@eurofarma.com
Status Not yet recruiting
Phase Phase 3
Start date October 30, 2025
Completion date July 30, 2027
View Details
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