drugset / Trial / NCT05378503

Phase IV Study of Qsymia in Obese Patients

NCT05378503

Phase 4 Completed 232 enrolled Alvogen Korea
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this clinical trial is to evaluate the weight loss effect and safety after administration of the test drug Qsymia in obese patients. To this end, the primary objective is to compare the weight change rate (%) between the study groups compared to the placebo groups at week 56 after administration of the investigational product. The secondary objective is to compare the weight change rate (%) at each evaluation point after administration of the investigational product, the proportions of subjects who lost more than 5% and more than 10% of weight at each evaluation point, and changes in weight/BMI/waist circumference/heart rate/blood pressure between the study groups compared to the placebo groups.

Timeline

Start
2021-09-17
Primary completion
2023-10-30
Completion
2023-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject VI-0521 Unknown 7.5 mg
Subject VI-0521 Unknown 15 mg
Subject VI-0521 Unknown 46 mg
Subject VI-0521 Unknown 92 mg

Indications