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 Obesity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 729
- 试验地点
- 20
- 主要终点
- Percentage change in total body weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Combination tablet containing Zonisamide SR placebo plus bupropion SR placebo SR = Sustained Release
干预措施: Zonisamide SR placebo/ bupropion SR placebo (Drug)
Bupropion 360
Combination tablet containing Zonisamide SR placebo plus bupropion SR 360 mg/day; SR = Sustained Release
干预措施: Zonisamide SR placebo/ bupropion SR 360 mg/day (Drug)
Zonisamide 120
Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR placebo; SR = Sustained Release
干预措施: Zonisamide SR 120 mg/day/ bupropion SR placebo (Drug)
Zonisamide 360
Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR placebo; SR = Sustained Release
干预措施: Zonisamide SR 360 mg/day/ bupropion SR placebo (Drug)
Zonisamide 120/Bupropion 360
Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release
干预措施: Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day (Drug)
Zonisamide 360/Bupropion 360
Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release
干预措施: Zonisamide SR 360 mg/day/ bupropion SR 360 mg/day (Drug)
结局指标
主要结局
Percentage change in total body weight
时间窗: from baseline to 24 weeks
次要结局
未报告次要终点