Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IV Clinical Trial to Evaluate Efficacy and Safety of Qsymia in Obese Patients
Overview
- Phase
- Phase 4
- Intervention
- Qsymia 3.75Mg-23Mg Extended Release Capsule
- Conditions
- Obesity
- Sponsor
- Alvogen Korea
- Enrollment
- 232
- Locations
- 8
- Primary Endpoint
- Weight change rate(percent)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult men and women aged 19 to 70 years
- •Obese patients with BMI ≥ 25 kg/m2 at screening visit and visit 2
- •Those who agreed to low-calorie regimen and exercise therapy during the study at screening visit
- •From screening visit prior to randomization visit (Visit 2), low-calorie regimen and exercise therapy compliances are all ≥ 70%
- •From screening visit prior to randomization visit (Visit 2), those who fails to lose weight by at least 10% due to a low-calorie regimen and exercise therapy.
- •Those who voluntarily decided to participate and gave written consent after being provided with and understanding the detailed explanation on this clinical trial
Exclusion Criteria
- •Patients with glaucoma
- •Thyroid dysfunction (hyperthyroidism, hypothyroidism) (however, for hypothyroidism, the case of taking therapeutic agents stably at least 3 months prior to the screening visit is allowed)
- •Arteriosclerosis patients with symptoms such as intermittent lameness and lower extremity pain
- •Patients with type 1 diabetes or those with type 2 diabetes who are taking diabetic medications other than metformin. (However, metformin is allowed only if it was administered without dose change 1 month prior to screening visit.)
- •Those who are taking monoamine oxidase (MAO) inhibitors at screening visit or who had taken less than 14 days before screening
- •Patients with SBP ≥ 160 mmHg, DBP ≥ 100 mmHg, or pulmonary hypertension at screening visit
- •A history of eating disorders, drug or alcohol abuse
- •A history of surgery for weight loss (e.g., bariatric surgery)
- •A weight change of \> 5kg within 3 months prior to the screening visit
- •A history of mental illness (e.g., bipolar disorder, depression, suicidal ideation, etc.)
Arms & Interventions
Active
1. Administration of Qsymia 3.75mg/23mg once a daily for 2-week(W2), and then administration of Qsymia 7.5mg/46mg once a daily for 12-week(W14). 2-1. At W14, if the weight loss rate is 3% or more, administration of Qsymia 7.5mg/46mg once a daily by the end of visit(W56). 2-2. At W14, if the weight loss rate is NOT 3% or more, administration of Qsymia 11.25mg/69mg once a daily for 2-week(W16), and then administration of Qsymia 15mg/92mg once a daily by the end of visit(W56).
Intervention: Qsymia 3.75Mg-23Mg Extended Release Capsule
Active
1. Administration of Qsymia 3.75mg/23mg once a daily for 2-week(W2), and then administration of Qsymia 7.5mg/46mg once a daily for 12-week(W14). 2-1. At W14, if the weight loss rate is 3% or more, administration of Qsymia 7.5mg/46mg once a daily by the end of visit(W56). 2-2. At W14, if the weight loss rate is NOT 3% or more, administration of Qsymia 11.25mg/69mg once a daily for 2-week(W16), and then administration of Qsymia 15mg/92mg once a daily by the end of visit(W56).
Intervention: Qsymia 7.5Mg-46Mg Extended Release Capsule
Active
1. Administration of Qsymia 3.75mg/23mg once a daily for 2-week(W2), and then administration of Qsymia 7.5mg/46mg once a daily for 12-week(W14). 2-1. At W14, if the weight loss rate is 3% or more, administration of Qsymia 7.5mg/46mg once a daily by the end of visit(W56). 2-2. At W14, if the weight loss rate is NOT 3% or more, administration of Qsymia 11.25mg/69mg once a daily for 2-week(W16), and then administration of Qsymia 15mg/92mg once a daily by the end of visit(W56).
Intervention: Qsymia 11.25Mg-69Mg Extended Release Capsule
Active
1. Administration of Qsymia 3.75mg/23mg once a daily for 2-week(W2), and then administration of Qsymia 7.5mg/46mg once a daily for 12-week(W14). 2-1. At W14, if the weight loss rate is 3% or more, administration of Qsymia 7.5mg/46mg once a daily by the end of visit(W56). 2-2. At W14, if the weight loss rate is NOT 3% or more, administration of Qsymia 11.25mg/69mg once a daily for 2-week(W16), and then administration of Qsymia 15mg/92mg once a daily by the end of visit(W56).
Intervention: Qsymia 15Mg-92Mg Extended Release Capsule
Placebo
Administration of Qsymia placebo once a daily by the end of visit(W56).
Intervention: Placebo
Outcomes
Primary Outcomes
Weight change rate(percent)
Time Frame: Week 56
Weight change rate(percent) from the baseline at week 56 after administration of the investigational product.
Secondary Outcomes
- Weight change rate(percent)(weeks 14, 28, and 42)
- The amounts of changes from the baseline in body weight(weeks 14, 28, 42, and 56)
- The proportions(percent) of subjects whose body weight has changed(weeks 14, 28, 42, and 56)
- The amounts of changes from the baseline in waist circumference(weeks 14, 28, 42, and 56)
- The amounts of changes from the baseline in BMI(weeks 14, 28, 42, and 56)
- The amounts of changes from the baseline in heart rate(weeks 14, 28, 42, and 56)
- The amounts of changes from the baseline in blood pressure(Systolic and diastolic)(weeks 14, 28, 42, and 56)