A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 401
- 主要终点
- Mean Change From Baseline in Body Weight at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the effect of SCH 497079 on weight in obese and overweight participants. The primary measure of effectiveness is the change in body weight during treatment. Additional measures include waist circumference and body mass index (BMI). In addition, the safety of SCH 497079 in obese and overweight participants will be evaluated. The primary hypothesis is that treatment with SCH 497079 will be more efficacious than that with placebo with respect to the primary efficacy variable.
详细描述
Following Screening, eligible participants will enroll in a Run-in Period. Participants who qualify for continuation in the study according to the entry criteria will be randomized to one of two treatment groups (SCH 497079 or placebo in a 2:1 ratio) with stratification according to gender.
Baseline measurements for the primary efficacy endpoint, as well as secondary endpoints will be evaluated at the Randomization Visit (Visit 3). Following randomization, participants will be treated for 12 weeks with double-blind study drug as adjunct to a 500 kcal deficit diet.
Participants will have scheduled visits after the Randomization Visit at 2 to 4 week intervals. Each participant will be encouraged to adhere to medication and dietary instructions.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 years of age, of either sex, and of any race.
- •Obese or overweight participants.
排除标准
- •Participants who have a history of major eating disorders, gastrointestinal (GI) surgery, active serious cardiovascular, pulmonary, endocrine, neurologic, infectious, GI, hepatic, renal, hematologic, immunologic or psychiatric disease or diabetes.
研究组 & 干预措施
SCH 497079
SCH 497079, administered orally, once daily
干预措施: SCH 497079 (Drug)
Placebo
Placebo capsules, administered orally, once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Body Weight at Week 12
时间窗: Baseline and Week 12
Participant's body weight was measured in kilograms. For participants who discontinued during the study, last observation carried forward (LOCF) approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.
次要结局
- Mean Change From Baseline in Body Mass Index (BMI) at Week 12(Baeline and Week 12)
- Mean Change From Baseline in Waist Circumference at Week 12(Baseline and Week 12)
- Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12(Baseline and Week 12)
- Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12(Baseline and Week 12)