Safety and Efficacy of Different Combinations of Zonisamide-CR Plus Bupropion-SR to Treat Uncomplicated Obesity

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine which of seven combinations of Zonisamide CR and Bupropion SR gives the best weight loss and is safe and well tolerated for the treatment of obesity not associated with the complications of obesity such as diabetes. In a previous study, the combination of zonisamide and bupropion SR was shown to be effective for weight loss compared to either zonisamide, bupropion SR alone or placebo. It is thought that by adjusting the doses of each drug, giving zonisamide in a controlled release (CR) form and increasing the doses more slowly, more weight loss and less side effects can be attained.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orexigen Therapeutics, Inc
• Treatments: Bupropion; Zonisamide

Criteria

Inclusion Criteria:

• Have body mass index (BMI) of 30 to 43 kg/m2

• Free from any other clinically significant illness or disease as determined by medical history and physical examination

• 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, beta-blockers and clonidine. Medical regimen must be stable for at least 6 weeks

• LDL cholesterol < 190 mg/dL and triglycerides < 400 mg/dL. Medications for treatment of dyslipidemia are allowed as long as medical regimen has been stable for at least 6 weeks

• Negative serum pregnancy test in women with an intact uterus

• Score < 15 for depression and score < 15 for anxiety on Hospital Anxiety and Depression Scale (HADS)

• No clinically significant abnormality on ECG

• Not on eExcluded concomitant medications

• If female with intact uterus, be non-lactating, and agree to use effective contraception throughout the study period and for 30 days after discontinuation of study drugs.

• Able to comply with all required study procedures and schedule

• Able to use and have access to a touch tone telephone and to speak and read English

Exclusion Criteria:

• Obesity of known endocrine or genetic origin

• Serious medical condition

• Serious psychiatric illness

• Active suicidal ideation; score > 2 on the Mood Assessment questionnaire

• A response to Bipolar Disorder questions indicating the presence of Bipolar Disorder

• Type I diabetes mellitus or Type II diabetes mellitus requiring pharmacotherapy

• History of alcohol or drug abuse, current or within 5 years

• History of bulimia or anorexia nervosa

• History of surgical intervention for obesity

• History of seizure disorder or predisposition to seizures (e.g., history of cerebrovascular accident, significant head trauma, brain surgery, skull fracture, subdural hematoma, or alcohol withdrawal or febrile seizures)

• History of hypersensitivity to sulfonamides ("sulfa"), bupropion, or zonisamide

• History of nephrolithiasis (renal calculi)

• History of treatment with bupropion SR (Wellbutrin, Zyban) or zonisamide (Zonegran) within 12 months

• Use of drugs, herbs, or dietary supplements known to significantly affect body weight or participation in a weight loss management program within one month prior to baseline

• Loss or gain of more than 4.0 kilos within 3 months

• Women of child bearing potential not adhering to an acceptable form of contraception

• Pregnant or breast-feeding women

• Use of investigational drug, device or procedure within 30 days

• Participation in any previous clinical trial conducted by Orexigen Therapeutics

• Planned surgical procedure that can impact the conduct of the study

• Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study