Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects With Prader-Willi Syndrome to Evaluate Total Body Weight, Food-related Behavior, and Safety Over 6 Months
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Zafgen, Inc.
- 入组人数
- 108
- 试验地点
- 15
- 主要终点
- Change in total body weight
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adolescent and adult subjects with Prader-Willi Syndrome.
详细描述
Phase 3, Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects with Prader-Willi Syndrome to Evaluate Total Body Weight, Food-related Behavior, and Safety Over 6 Months
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed genetic diagnosis of Prader-Willi Syndrome
- •Age 12-65
- •Age 12-17: BMI ≥ 95th percentile for age and gender
- •Age 18-65: BMI ≥27 to ≤60 kg/m2
排除标准
- •Subjects living in a group home ≥ 50% of the time
- •Recent use (within 3 months) of weight loss agents including herbal medication
- •Poorly controlled severe psychiatric disorders
研究组 & 干预措施
Placebo
Intervention: ZGN-440 Placebo for Injectable Suspension
干预措施: ZGN-440 Placebo for Injectable Suspension (Drug)
ZGN-440 Injectable Suspension (1.8 mg)
Intervention: ZGN-440 for Injectable Suspension
干预措施: ZGN-440 for Injectable Suspension (Drug)
ZGN-440 Injectable Suspension (2.4 mg)
Intervention: ZGN-440 for Injectable Suspension
干预措施: ZGN-440 for Injectable Suspension (Drug)
结局指标
主要结局
Change in total body weight
时间窗: Baseline to Week 29
Change in hyperphagia-related behavior as measured by total score of a Hyperphagia Questionnaire
时间窗: Baseline to Week 29
次要结局
- Change in LDL cholesterol(Baseline to Week 29)
- Change in total body fat mass as measured by DXA(Baseline to Week 29)
- Change in HDL cholesterol(Baseline to Week 29)
- Change in total body mass as measured by DXA(Baseline to Week 29)
- Change in triglyceride(Baseline to Week 29)