A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Efficacy of the Co-administration of Canagliflozin 300 mg and Phentermine 15 mg Compared With Placebo for the Treatment of Non-diabetic Overweight and Obese Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 335
- 主要终点
- Percent Change From Baseline in Body Weight at Week 26
研究概览
简要总结
The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.
详细描述
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect), parallel-group, multicenter study of the effects of canagliflozin and phentermine co-administration in non-diabetic overweight or obese participants. The study will be conducted for about 33 weeks, approximately 344 participants will be randomly assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo. All participants will be also provided with diet and exercise counseling for weight loss (standardized non-pharmacological therapy).
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
- •Must have BMI >=30 kg/m2 and <50 kg/m2 at screening or BMI >=27 kg/m2 and <50 kg/m2 at screening in the presence of a comorbidity of hypertension and/or dyslipidemia
- •Must have stable weight, ie, change of < =5% in the 3 months before screening
- •Must agree to utilize a highly effective method of birth control
排除标准
- •An established diagnosis of diabetes mellitus
- •Has a history of obesity with a known secondary cause (eg, Cushing's disease/syndrome)
- •Has a history of hereditary glucose-galactose malabsorption or primary renal glycosuria
- •Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 12 weeks before screening
- •Has an Glycated hemoglobin (HBA1c) greater than or equal (>=) to 65 percent
- •An average of 3 seated blood pressure (BP) readings of systolic BP >= 160 mm Hg and/or Diastolic BP >= 100 millimeters of mercury at screening
研究组 & 干预措施
Canagliflozin + Phentermine
300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.
干预措施: Canagliflozin (Drug)
Canagliflozin + Phentermine
300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.
干预措施: Phentermine (Drug)
Canagliflozin + Placebo (Phentermine)
300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.
干预措施: Canagliflozin (Drug)
Canagliflozin + Placebo (Phentermine)
300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.
干预措施: Matching Placebo to Phentermine (Drug)
Phentermine + Placebo (Canagliflozin)
15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.
干预措施: Phentermine (Drug)
Phentermine + Placebo (Canagliflozin)
15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.
干预措施: Matching Placebo to Canagliflozin (Drug)
Placebo
Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.
干预措施: Matching Placebo to Canagliflozin (Drug)
Placebo
Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.
干预措施: Matching Placebo to Phentermine (Drug)
结局指标
主要结局
Percent Change From Baseline in Body Weight at Week 26
时间窗: Week 26
The percent change from baseline in body weight at Week 26 was analysed.
次要结局
- Absolute Change From Baseline in Body Weight at Week 26(Week 26)
- Change From Baseline in Systolic Blood Pressure at Week 26(Week 26)
- Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26(Week 26)