A Phase III, Randomized, Double-Blind, Parallel-Design Study Comparing Multiple Doses of VI-0521 to Placebo and Their Single-Agent Phentermine and Topiramate Constituents for the Treatment of Obesity in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- VIVUS LLC
- 入组人数
- 756
- 试验地点
- 1
- 主要终点
- Percent Weight Loss From Baseline to Week 28
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.
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
- •70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2
- •Informed Consent
- •Females of child-bearing potential must be using adequate contraception
排除标准
- •Stroke/myocardial infarction (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 elevated intraocular pressure
- •Pregnancy or breastfeeding
- •Drug or Alcohol abuse
- •Smoking cessation within previous 3 months or plans to quit smoking during study
- •Eating disorders within past year
- •Cholelithiasis within past 6 months
- •Type 2 diabetes
- •Previous bariatric surgery
- •Bipolar disorder or psychosis
- •Steroid hormone therapy not stable for 3 months
- •Systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg
研究组 & 干预措施
VI-0521 Top
VI-0521; high dose phentermine/topiramate
干预措施: VI-0521 (Drug)
VI-0521 Mid
VI-0521; mid dose phentermine/topiramate
干预措施: VI-0521 (Drug)
TPM 46
mid dose topiramate
干预措施: topiramate (Drug)
TPM 92
high dose topiramate
干预措施: topiramate (Drug)
PHEN 7.5
mid dose phentermine
干预措施: phentermine (Drug)
PHEN 15
high dose phentermine
干预措施: phentermine (Drug)
Placebo
干预措施: VI-0521 (Drug)
结局指标
主要结局
Percent Weight Loss From Baseline to Week 28
时间窗: baseline to 28 weeks
Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)
Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF
时间窗: baseline to 28 weeks
次要结局
未报告次要终点