NCT05378503

Phase IV Study of Qsymia in Obese Patients

Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IV Clinical Trial to Evaluate Efficacy and Safety of Qsymia in Obese Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Alvogen Korea · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Qsymia 3.75Mg-23Mg Extended Release Capsule	From W0 to W2, once a daily.
DRUG	Qsymia 7.5Mg-46Mg Extended Release Capsule	1. From W2 to W14, once a daily. 2. At W14, if the weight loss rate is 3% or more, from W14 to W56(the end of visit), once a daily.
DRUG	Qsymia 11.25Mg-69Mg Extended Release Capsule	At W14, if the weight loss rate is NOT 3% or more, from W14 to W16, once a daily.
DRUG	Qsymia 15Mg-92Mg Extended Release Capsule	At W14, if the weight loss rate is NOT 3% or more, from W16 to W56(the end of visit), once a daily.
DRUG	Placebo	From W0(Randomisation) to W56(the End of visit) once a daily.

Timeline

• Start date: 2021-09-17
• Primary completion: 2023-10-30
• Completion: 2023-10-30
• First posted: 2022-05-18
• Last updated: 2024-01-31

Locations

8 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study