Title
Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity
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
Phase
Phase 2Lead Sponsor
Orexigen Therapeutics, IncStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
ObesityIntervention/Treatment
zonisamide bupropion ...Study Participants
729The 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.
2 zonisamide SR 30 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
2 placebo combination tablets twice daily for 16 weeks (maintenance period)
2 placebo and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
2 zonisamide SR 90 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
2 zonisamide SR 30 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
2 zonisamide SR 90 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
Combination tablet containing Zonisamide SR placebo plus bupropion SR placebo SR = Sustained Release
Combination tablet containing Zonisamide SR placebo plus bupropion SR 360 mg/day; SR = Sustained Release
Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR placebo; SR = Sustained Release
Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR placebo; SR = Sustained Release
Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release
Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release
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