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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
232
From W0 to W2, once a daily.
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.
At W14, if the weight loss rate is NOT 3% or more, from W14 to W16, once a daily.
At W14, if the weight loss rate is NOT 3% or more, from W16 to W56(the end of visit), once a daily.
From W0(Randomisation) to W56(the End of visit) once a daily.
KyungHee Univ. Hospital
Seoul, Dongdaemun-gu, South Korea
KyungHee Univ. Hospital at Gangdong
Seoul, Gangdong-gu, South Korea
The Catholic Univ. of Korea Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Sejong Hospital
Bucheon-si, Gyeonggi-do, South Korea
Hanyang Univ. Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Gil Hospital
Incheon, Namdong-gu, South Korea
GangNeung Asan Hospital
Gangneung, Sacheon-myeon, South Korea
Severance Hospital
Seoul, Seodaemun-gu, South Korea
Weight change rate(percent)
Weight change rate(percent) from the baseline at week 56 after administration of the investigational product.
Time frame: Week 56
Weight change rate(percent)
Weight change rate(percent) from the baseline at weeks 14, 28, and 42 after administration of the investigational product.
Time frame: weeks 14, 28, and 42
The proportions(percent) of subjects whose body weight has changed
The proportions(percent) of subjects whose body weight has changed by 5 percents or more and 10 percents or more at weeks 14, 28, 42, and 56 after administration of the investigational product.
Time frame: weeks 14, 28, 42, and 56
The amounts of changes from the baseline in body weight
The amounts of changes from the baseline in body weight at weeks 14, 28, 42, and 56 after administration of the investigational product
Time frame: weeks 14, 28, 42, and 56
The amounts of changes from the baseline in waist circumference
The amounts of changes from the baseline in waist circumference at weeks 14, 28, 42, and 56 after administration of the investigational product
Time frame: weeks 14, 28, 42, and 56
The amounts of changes from the baseline in BMI
The amounts of changes from the baseline in BMI at weeks 14, 28, 42, and 56 after administration of the investigational product
Time frame: weeks 14, 28, 42, and 56
The amounts of changes from the baseline in heart rate
The amounts of changes from the baseline in heart rate at weeks 14, 28, 42, and 56 after administration of the investigational product
Time frame: weeks 14, 28, 42, and 56
The amounts of changes from the baseline in blood pressure(Systolic and diastolic)
The amounts of changes from the baseline in blood pressure(Systolic and diastolic) at weeks 14, 28, 42, and 56 after administration of the investigational product
Time frame: weeks 14, 28, 42, and 56
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