NCT00553787已完成3 期
A Phase III Randomized, Double-Blind, Placebo Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- VIVUS LLC
- 入组人数
- 2,487
- 试验地点
- 1
- 主要终点
- Percent Weight Loss From Baseline to Week 56
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent
- •BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)
- •70 years of age or less
- •Have 2 or more of the following obesity-related co-morbid conditions:
- •Systolic blood pressure 140-160 mmHg (130-160 if diabetic);
- •Diastolic blood pressure 90-100 mmHg (85-100 if diabetic);
- •Requirement for 2 or more medications to achieve control (<140/90 mmHg)
- •Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (<200 mg/dL)
- •At lease one of the following metabolic criteria:
- •Fasting blood glucose level > 100 mg/dL
- •Glucose level > 140 mg/dL
- •Diagnosis of type 2 diabetes
- •Waist circumference ≥ 102 cm for men or ≥88 cm for women
排除标准
- •Stroke/MI/unstable cardiovascular disease within 6 months
- •Clinically significant renal, hepatic or psychiatric disease
- •Unstable thyroid disease or replacement therapy
- •Nephrolithiasis
- •Obesity of known genetic or endocrine origin
- •Participation in a formal weight loss program or lifestyle intervention
- •Glaucoma or intraocular pressure
- •Pregnancy or breastfeeding
- •Drug or Alcohol abuse
- •Smoking cessation within previous 3 months or plans to quit smoking during study
- •Eating disorders
- •Cholelithiasis within past 6 months
- •Excluded medications
- •Type 1 diabetes or use of any antidiabetic medication other than metformin
- •Previous bariatric surgery
- •Bipolar disorder or psychosis
- •Steroid hormone therapy
- •Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
- •Creatinine clearance < 60 mL/minute
研究组 & 干预措施
VI-0521 Top
Experimental
high dose experimental treatment
干预措施: VI-0521 (Drug)
VI-0521 Mid
Experimental
mid dose experimental treatment
干预措施: VI-0521 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: VI-0521 (Drug)
结局指标
主要结局
Percent Weight Loss From Baseline to Week 56
时间窗: Baseline to 56 weeks
Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF
时间窗: Baseline to 56 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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