Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

Condition(s) targeted: Obesity

Intervention: Zonisamide SR placebo plus bupropion SR placebo (Drug); Zonisamide SR placebo plus bupropion SR 360 mg/day (Drug); Zonisamide SR 120 mg/day plus bupropion SR placebo (Drug); Zonisamide SR 360 mg/day plus bupropion SR placebo (Drug); Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day (Drug); Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Orexigen Therapeutics, Inc

Official(s) and/or principal investigator(s):
Matthew Acampora, MD, Principal Investigator, Affiliation: Internal Medicine Associates of Charlotte
Caroline Apovian, MD, Principal Investigator, Affiliation: Nutrition and Weight Management Center
James Bergthold, MD, Principal Investigator, Affiliation: Summit Research Network (Oregon), Inc.
Joseph Cleaver, MD, Principal Investigator, Affiliation: The Cooper Institute
Adnan Dahdul, MD, Principal Investigator, Affiliation: FutureCare Studies
Ken Fujioka, MD, Principal Investigator, Affiliation: Nutrition and Metabolic Research
Jeffrey Geohas, MD, Principal Investigator, Affiliation: Radiant Research, Chicago
Mark Graves, MD, Principal Investigator, Affiliation: Welborn Clinic
Alok Gupta, MD, Principal Investigator, Affiliation: Pennington Biomedical Research Center
Wayne Harper, MD, Principal Investigator, Affiliation: Wake Research Associates, LLC
Jonathan Henry, MD, Principal Investigator, Affiliation: Summit Research Network (Michigan), Inc.
Diane Krieger, MD, Principal Investigator, Affiliation: Miami Research Associates
Michael Levy, MD, Principal Investigator, Affiliation: Behavioral Medical Research
Raymond Plodkowski, MD, Principal Investigator, Affiliation: Center for Nutrition and Metabolic Disorders, University of Nevada School of Medicine
Domenica Rubino, MD, Principal Investigator, Affiliation: Washington Center for Weight Management and Research
Stan Self, MD, Principal Investigator, Affiliation: SelfCenter, PC
Diane Smith, MD, Principal Investigator, Affiliation: CSRA Partners in Health, Inc.
Timothy Smith, MD, Principal Investigator, Affiliation: Mercy Health Research
Claire Waltman, MD, Principal Investigator, Affiliation: Summit Research Network (Seattle), LLC
Holly Wyatt, MD, Principal Investigator, Affiliation: Center for Human Nutrition/UCD

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: 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

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

Primary outcome: Percentage change in total body weight

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

SelfCenter, PC, Fairhope, Alabama 36532, United States; Recruiting
Martha Brenner, Phone: 251-928-7028, Email: brennerx@bellsouth.net
Stan Self, MD, Principal Investigator

Nutrition and Metabolic Research, La Jolla, California 92037, United States; Recruiting
Laurie Stewart, Phone: 858-652-5570, Email: stewart.laura@scrippshealth.org
Ken Fujioka, MD, Principal Investigator

Center for Human Nutrition/UCD, Denver, Colorado 80220, United States; Recruiting
Jessica Kohring, Phone: 303-315-9095, Email: Jessica.kohring@uchsc.edu
Holly Wyatt, MD, Principal Investigator

Miami Research Associates, Miami, Florida 33143, United States; Recruiting
Anita Puras, Phone: 305-598-3125, Ext: 4228, Email: apuras@miamiresearch.com
Diane Krieger, MD, Principal Investigator

CSRA Partners in Health, Inc., Augusta, Georgia 30909, United States; Recruiting
Jenni Wilcox, Phone: 706-860-3001, Email: lpnpih@aol.com
Diane Smith, MD, Principal Investigator

Radiant Research, Chicago, Chicago, Illinois 60610, United States; Recruiting
Lynette Badal, Phone: 312-494-2295, Email: lynettebadal@radiantresearch.com
Jeffrey Geohas, MD, Principal Investigator

Welborn Clinic, Evansville, Indiana 47713, United States; Recruiting
Robin Fluty, Phone: 812-426-9211, Email: flutyr@welbornclinic.com
Mark Graves, MD, Principal Investigator

Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808, United States; Recruiting
Ami Parks, Email: amiparks@pbrc.edu
Alok Gupta, MD, Principal Investigator

Nutrition and Weight Management Center, Boston Medical Center, Boston, Massachusetts 02118, United States; Recruiting
Florencia Ziemke, Phone: 617-638-8511, Email: florencia.ziemke@bmc.org
Caroline Apovian, MD, Principal Investigator

FutureCare Studies, Springfield, Massachusetts 01103, United States; Recruiting
Annette Scarnici, Phone: 413-788-1400, Email: annette.white@futurecarestudies.com
Adnan Dahdul, MD, Principal Investigator

Summit Research Network (Michigan), Inc., Farmington Hills, Michigan 48336, United States; Recruiting
Carrie Tallman, Phone: 877-908-2273, Email: ctallman@summitnetwork.com
Jonathan Henry, MD, Principal Investigator

Mercy Health Research, St. Louis, Missouri 63141, United States; Recruiting
Donna Straatmann, Phone: 314-251-8890, Ext: 28137, Email: Donna.straatmann@mercy.net
Timothy Smith, MD, Principal Investigator

Center for Nutrition and Metabolic Disorders, University of Nevada School of Medicine, Reno, Nevada 89557, United States; Recruiting
Jolyn Wirshing, Phone: 775-682-7961, Email: jwirshing@medicine.nevada.edu
Raymond Plodkowski, MD, Principal Investigator

Behavioral Medical Research, Staten Island, New York 10305, United States; Recruiting
Daniela Pantea, Phone: 718-351-3319, Email: d.pantea@bmrsi.com
Michael Levy, MD, Principal Investigator

Internal Medicine Associates of Charlotte, Charlotte, North Carolina 28277, United States; Recruiting
Veronica Rose, Phone: 704-364-4280, Email: CNPMVER@AOL.COM
Matthew Acampora, MD, Principal Investigator

Wake Research Associates, LLC, Raleigh, North Carolina 27612, United States; Recruiting
Marsha Peery, Phone: 919-781-2514, Email: regulatory@wakeresearch.com
Wayne Harper, MD, Principal Investigator

Summit Research Network (Oregon), Inc., Portland, Oregon 97210, United States; Recruiting
Sarah Mueller, Phone: 503-279-8252, Email: smueller@summitnetwork.com
James Bergthold, MD, Principal Investigator

The Cooper Institute, Dallas, Texas 75230, United States; Recruiting
Candice Berryman, Phone: 972-341-3242, Email: cberryman@cooperinst.org
Joseph Cleaver, MD, Principal Investigator

Washington Center for Weight Management and Research, Arlington, Virginia 22201, United States; Recruiting
Jan Gagen, Phone: 703-807-0037, Email: jangagen@gmail.com
Domenica Rubino, MD, Principal Investigator

Summit Research Network (Seattle), LLC., Seattle, Washington 98104, United States; Recruiting
Nick Reichmann, Phone: 800-426-2273
Claire Waltman, MD, Principal Investigator

Starting date: June 2008
Ending date: June 2009
Last updated: June 29, 2008