Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

Study Overview
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Brief Summary
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The purpose of this study is determine if the combination of zonisamide SR and bupropion SR are is more effective than either drug given alone or placebo in the treatment of obesity.

Official Title
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A Phase IIB, Multi-Center, Dose-Parallel, Randomized, Double-Blind, Monotherapy and Placebo-Controlled Safety and Efficacy Study of Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

Conditions
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Obesity

Intervention / Treatment
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* Drug: Zonisamide SR placebo/ bupropion SR placebo
* Drug: Zonisamide SR placebo/ bupropion SR 360 mg/day
* Drug: Zonisamide SR 120 mg/day/ bupropion SR placebo
* Drug: Zonisamide SR 360 mg/day/ bupropion SR placebo
* Drug: Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day
* Drug: Zonisamide SR 360 mg/day/ bupropion SR 360 mg/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male subjects, 18 to 65 years of age Have body mass index (BMI) ≥ 30 kg/m2 and ≤ 45 kg/m2 for subjects with uncomplicated obesity, and BMI of ≥ 27 kg/m2 and ≤ 45 kg/m2 for subjects with obesity and dyslipidemia and/or controlled hypertension Non-smoker and no use of tobacco or nicotine products for at least 6 months prior to screening Normotensive (systolic ≤140 mm Hg; diastolic ≤90 mm Hg). Anti-hypertensive medications are allowed with the exception of adrenergic blockers and clonidine. Medical regimen must be stable for at least 6 weeks prior to randomization Triglycerides <400 mg/dL. Medications for treatment of dyslipidemia are allowed with the exception of cholestyramine and cholestypol as long as medical regimen has been stable for at least 6 weeks prior to randomization No clinically significant laboratory abnormalities Negative urine drug screen Negative serum pregnancy test in women of child-bearing potential Women of child-bearing potential must be non-lactating, and agree to use acceptable contraception throughout the study period and for 30 days after discontinuation of study drug Able to comply with all required study procedures and schedule Able to speak and read English Willing and able to give written informed consent Exclusion Criteria: Obesity of known endocrine or genetic origin (e.g., untreated hypothyroidism, Cushing's syndrome, polycystic ovary syndrome) Serious medical condition History of malignancy within the previous 5 years, with exception of non-melanoma skin cancer or surgically cured cervical cancer. History of suicide attempt or serious psychiatric illness History of Major Depressive Disorder within the past 2 years In need of medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months prior to randomization Type I or Type II diabetes History of alcohol or drug abuse or dependence as determined by the Investigator within 1 year prior to randomization History of surgical or device (e.g. gastric banding) intervention for obesity History of seizures or predisposition to seizures History of hypersensitivity to sulfonamides (sulfa), bupropion, or zonisamide History of treatment with bupropion SR (Wellbutrin, Zyban) or zonisamide (Zonegran) within previous 12 months History of nephrolithiasis (renal calculi) Loss or gain of more than 4.0 kg within 3 months prior to randomization Women of child bearing potential not adhering to a medically acceptable form of contraception Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Combination tablet containing Zonisamide SR placebo plus bupropion SR placebo SR = Sustained Release | Drug: Zonisamide SR placebo/ bupropion SR placebo<br>* 2 placebo combination tablets twice daily for 16 weeks (maintenance period)<br>|
| Active Comparator: Bupropion 360<br>Combination tablet containing Zonisamide SR placebo plus bupropion SR 360 mg/day; SR = Sustained Release | Drug: Zonisamide SR placebo/ bupropion SR 360 mg/day<br>* 2 placebo and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)<br>|
| Active Comparator: Zonisamide 120<br>Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR placebo; SR = Sustained Release | Drug: Zonisamide SR 120 mg/day/ bupropion SR placebo<br>* 2 zonisamide SR 30 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)<br>|
| Active Comparator: Zonisamide 360<br>Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR placebo; SR = Sustained Release | Drug: Zonisamide SR 360 mg/day/ bupropion SR placebo<br>* 2 zonisamide SR 90 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)<br>|
| Experimental: Zonisamide 120/Bupropion 360<br>Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release | Drug: Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day<br>* 2 zonisamide SR 30 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)<br>|
| Experimental: Zonisamide 360/Bupropion 360<br>Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release | Drug: Zonisamide SR 360 mg/day/ bupropion SR 360 mg/day<br>* 2 zonisamide SR 90 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in total body weight |  | from baseline to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, zonisamide, bupropion