Phase IV Study of Qsymia in Obese Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Drug: Qsymia 3.75Mg-23Mg Extended Release Capsule
* Drug: Qsymia 7.5Mg-46Mg Extended Release Capsule
* Drug: Qsymia 11.25Mg-69Mg Extended Release Capsule
* Drug: Qsymia 15Mg-92Mg Extended Release Capsule
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.) Obesity due to endocrine disorders or genetic obesity A history of kidney stones or gallbladder stones within 6 months of the screening visit Patients who need to take furosemide (loop diuretic) or hydrochlorothiazide (thiazide-like diuretic) during the study (However, it is allowed only if it is administered for treatment of hypertension without dose change 3 months prior to screening visit.) Patients with renal impairment (CrCl < 60 mL/min) Patients with hepatic impairment (AST, ALT ≥ 2.5 X ULN) A history of treatment for transient ischemic attack (TIA), myocardial infarction, unstable angina, cerebral infarction, and cerebral hemorrhage, or angioplasty or coronary artery bypass grafting within 6 months prior to the screening visit (if it occurs before 6 months and is currently stable, it is possible to enroll) Patients with severe heart failure (NYHA class III or higher), arrhythmia requiring treatment, and clinically significant heart valve disease A history of anaphylaxis to active or minor ingredients of the investigational product Hypersensitivity reaction or idiosyncrasy to sympathomimetic amine A history of malignant tumor within 5 years prior to the screening visit (Surgery-resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia or thyroid cancer with no evidence of recurrence after 3 years of surgery are allowed) Pregnant or lactating women Those who disagree to the use of a medically acceptable contraception (see Section 14.1) during the study A history of systemic steroid administration for 14 days or more within 3 months of screening visit Within 3 months prior to the screening visit Taking Qsymia or Taking phentermine and topiramate in combination for weight loss or Taking phentermine or topiramate for other purposes Taking other appetite suppressants (including herbal medicines) excluding Qsymia (or drugs containing active ingredient of Qsymia) within 6 months prior to the screening visit Participation in other clinical trials within 3 months before the screening visit (participation is based on the last administration date of the investigational product) Other cases where the investigator determined that the subject is ineligible for participation in the obesity clinical study based on the history of medical or surgical disease or laboratory test results

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br>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). 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). | Drug: Qsymia 3.75Mg-23Mg Extended Release Capsule<br>* From W0 to W2, once a daily.<br>* Other names: Low dose titration;Drug: Qsymia 7.5Mg-46Mg Extended Release Capsule<br>* From W2 to W14, once a daily. At W14, if the weight loss rate is 3% or more, from W14 to W56(the end of visit), once a daily.<br>* Other names: Low dose maintenance;|
| Experimental: High dose<br>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). 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). | Drug: Qsymia 3.75Mg-23Mg Extended Release Capsule<br>* From W0 to W2, once a daily.<br>* Other names: Low dose titration;Drug: Qsymia 7.5Mg-46Mg Extended Release Capsule<br>* From W2 to W14, once a daily. At W14, if the weight loss rate is 3% or more, from W14 to W56(the end of visit), once a daily.<br>* Other names: Low dose maintenance;Drug: Qsymia 11.25Mg-69Mg Extended Release Capsule<br>* At W14, if the weight loss rate is NOT 3% or more, from W14 to W16, once a daily.<br>* Other names: High dose titration;Drug: Qsymia 15Mg-92Mg Extended Release Capsule<br>* At W14, if the weight loss rate is NOT 3% or more, from W16 to W56(the end of visit), once a daily.<br>* Other names: High dose maintenance;|
| Placebo Comparator: Placebo<br>Administration of Qsymia placebo once a daily by the end of visit(W56). | Drug: Placebo<br>* From W0(Randomisation) to W56(the End of visit) once a daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change rate(percent) | Weight change rate(percent) from the baseline at week 56 after administration of the investigational product. | Week 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change rate(percent) | Weight change rate(percent) from the baseline at weeks 14, 28, and 42 after administration of the investigational product. | 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. | 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 | 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 | 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 | 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 | 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 | weeks 14, 28, 42, and 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Qsymia, Phentermine, Topiramate, Alvogen Korea