NCT01818921已完成2 期
Randomized, Double-Blind, Placebo Controlled, Parallel Dose Ranging Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Over-weight and Obese Subjects With Prader-Willi Syndrome to Evaluate Weight Reduction, Food-related Behavior, Safety, and Pharmacokinetics Over 4 Weeks Followed by Optional 4-Week Open-Label Extension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Zafgen, Inc.
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Percent change in body weight from baseline to the end of the randomized dosing period.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Prader-Willi Syndrome due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting defect
- •BMI ≥25 kg/m2
- •Type 2 diabetes mellitus is allowed
- •Subject must agree to stay at the group home or under supervision of the group home or site staff (i.e. no home visits) for the duration of the study
- •Stable body weight during the past 3 months, except for during home visits
排除标准
- •Use of weight loss agents in the past 3 months
- •Type 1 diabetes mellitus
- •Current or anticipated chronic use of narcotics or opiates
研究组 & 干预措施
ZGN-440 sterile diluent
Placebo Comparator
Subjects will receive placebo twice weekly subcutaneous injections for up to 6 weeks.
干预措施: ZGN-440 sterile diluent (Drug)
1.2 mg ZGN-440 for injectable suspension
Experimental
Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.
干预措施: 1.2 mg ZGN-440 for injectable suspension (Drug)
1.8 mg ZGN-440 for injectable suspension
Experimental
Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.
干预措施: 1.8 mg ZGN-440 for injectable suspension (Drug)
结局指标
主要结局
Percent change in body weight from baseline to the end of the randomized dosing period.
时间窗: 4 weeks
次要结局
- Change in body weight (kg) from baseline to the end of the randomized dosing period(4 weeks)
- Change in hyperphagia behavior, drive, and severity score (total score) from baseline to the end of the randomized dosing period using the PWS Hyperphagia Questionnaire(4 weeks)
研究者
研究点 (1)
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