Official Title: “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 Uncomplicated Obesity”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: Zonisamide SR placebo plus bupropion SR placebo
  • 2 placebo tablets twice daily for 16 weeks (maintenance period)
• Drug: Zonisamide SR placebo plus bupropion SR 360 mg/day
  • 2 placebo and bupropion SR 90 mg tablets, twice daily for 16 weeks (maintenance period)
• Drug: Zonisamide SR 120 mg/day plus bupropion SR placebo
  • 2 zonisamide SR 30 mg and placebo tablets, twice daily for 16 weeks (maintenance period)
• Drug: Zonisamide SR 360 mg/day plus bupropion SR placebo
  • 2 zonisamide SR 90 mg and placebo tablets, twice daily for 16 weeks (maintenance period)
• Drug: Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day
  • 2 zonisamide SR 30 mg and bupropion SR 90 mg tablets, twice daily for 16 weeks (maintenance period)
• Drug: Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day
  • 2 zonisamide SR 90 mg and bupropion SR 90 mg tablets, twice daily for 16 weeks (maintenance period)

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Zonisamide SR placebo plus bupropion SR placebo
• Active Comparator: 2
  • Zonisamide SR placebo plus bupropion SR 360 mg/day
• Active Comparator: 3
  • Zonisamide SR 120 mg/day plus bupropion SR placebo
• Active Comparator: 4
  • Zonisamide SR 360 mg/day plus bupropion SR placebo
• Experimental: 5
  • Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day
• Experimental: 6
  • Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day

Primary Measures

• Percentage change in total body weight
  • Time Frame: from baseline to 24 weeks
    Safety Issue?: No

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
• 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)
• 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 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 hypersensitivity to sulfonamides ("sulfa"), bupropion, or zonisamide
• History of treatment with bupropion SR (Wellbutrin, Zyban) or zonisamide (Zonegran) within previous 12 months
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Orexigen Therapeutics, Inc

Overall Clinical Trial Officials and Contacts

Matthew Acampora, MD Principal Investigator Internal Medicine Associates of Charlotte  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00709371

Study ID Number: ZB-202

ClinicalTrials.gov Identifier: NCT00709371

Health Authority: United States: Food and Drug Administration