Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00709371

Run by

Orexigen Therapeutics, Inc

People needed

729

Starts

2008-07-01

Expected to finish

2009-07-01

Last updated by the study team

2012-11-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• SelfCenter, PC — Fairhope, Alabama, United States
• Nutrition and Metabolic Research — La Jolla, California, United States
• Center for Human Nutrition/UCD — Denver, Colorado, United States
• Miami Research Associates — Miami, Florida, United States
• CSRA Partners in Health, Inc. — Augusta, Georgia, United States
• Radiant Research, Chicago — Chicago, Illinois, United States
• Welborn Clinic — Evansville, Indiana, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Nutrition and Weight Management Center, Boston Medical Center — Boston, Massachusetts, United States
• FutureCare Studies — Springfield, Massachusetts, United States
• Summit Research Network (Michigan), Inc. — Farmington Hills, Michigan, United States
• Mercy Health Research — St Louis, Missouri, United States
• Center for Nutrition and Metabolic Disorders, University of Nevada School of Medicine — Reno, Nevada, United States
• Behavioral Medical Research — Staten Island, New York, United States
• Internal Medicine Associates of Charlotte — Charlotte, North Carolina, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• Summit Research Network (Oregon), Inc. — Portland, Oregon, United States
• The Cooper Institute — Dallas, Texas, United States
• Washington Center for Weight Management and Research — Arlington, Virginia, United States
• Summit Research Network (Seattle), LLC. — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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