Overview

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

Status:
Not yet recruiting

Trial end date:
2026-05-01

Target enrollment:

Participant gender:

Summary

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).

Phase:

Phase 3

Details

Lead Sponsor:

Eurofarma Laboratorios S.A.

Treatments:

Sibutramine
Topiramate