Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: Zonisamide SR placebo/ bupropion SR placebo; Drug: Zonisamide SR 120 mg/day/ bupropion SR placebo; Drug: Zonisamide SR 360 mg/day/ bupropion SR placebo; Drug: Zonisamide SR placebo/ bupropion SR 360 mg/day; Drug: Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day; Drug: Zonisamide SR 360 mg/day/ bupropion SR 360 mg/day

• Registration Number: NCT00709371
• Lead Sponsor: Orexigen Therapeutics, Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-29
• Study First Submitted QC: 2008-06-29
• Study Start: 2008-07
• Study First Posted: 2008-07-03
• Primary Completion: 2009-04
• Study Completion: 2009-07
• Status Verified: 2012-11
• Disposition First Submitted: 2012-11-26
• Disposition First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Disposition First Posted: 2012-11-29
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 729

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Zonisamide SR placebo/ bupropion SR placebo	Combination tablet containing Zonisamide SR placebo plus bupropion SR placebo SR = Sustained Release
Zonisamide 120	Zonisamide SR 120 mg/day/ bupropion SR placebo	Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR placebo; SR = Sustained Release
Zonisamide 360	Zonisamide SR 360 mg/day/ bupropion SR placebo	Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR placebo; SR = Sustained Release
Bupropion 360	Zonisamide SR placebo/ bupropion SR 360 mg/day	Combination tablet containing Zonisamide SR placebo plus bupropion SR 360 mg/day; SR = Sustained Release
Zonisamide 120/Bupropion 360	Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day	Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release
Zonisamide 360/Bupropion 360	Zonisamide SR 360 mg/day/ bupropion SR 360 mg/day	Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release

Primary Outcome Measures

Name	Time	Method
Percentage change in total body weight	from baseline to 24 weeks

Trial Locations

Locations (20)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States

Welborn Clinic; 🇺🇸 Evansville, Indiana, United States

Miami Research Associates; 🇺🇸 Miami, Florida, United States

Summit Research Network (Seattle), LLC.; 🇺🇸 Seattle, Washington, United States

Center for Human Nutrition/UCD; 🇺🇸 Denver, Colorado, United States

SelfCenter, PC; 🇺🇸 Fairhope, Alabama, United States

Nutrition and Metabolic Research; 🇺🇸 La Jolla, California, United States

CSRA Partners in Health, Inc.; 🇺🇸 Augusta, Georgia, United States

Radiant Research, Chicago; 🇺🇸 Chicago, Illinois, United States

Nutrition and Weight Management Center, Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Summit Research Network (Michigan), Inc.; 🇺🇸 Farmington Hills, Michigan, United States

FutureCare Studies; 🇺🇸 Springfield, Massachusetts, United States

Mercy Health Research; 🇺🇸 St. Louis, Missouri, United States

Wake Research Associates, LLC; 🇺🇸 Raleigh, North Carolina, United States

Behavioral Medical Research; 🇺🇸 Staten Island, New York, United States

The Cooper Institute; 🇺🇸 Dallas, Texas, United States

Internal Medicine Associates of Charlotte; 🇺🇸 Charlotte, North Carolina, United States

Summit Research Network (Oregon), Inc.; 🇺🇸 Portland, Oregon, United States

Washington Center for Weight Management and Research; 🇺🇸 Arlington, Virginia, United States

Center for Nutrition and Metabolic Disorders, University of Nevada School of Medicine; 🇺🇸 Reno, Nevada, United States