NCT02063295已完成2 期
Randomized, Double-Blind, Placebo Controlled, Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects With Hypothalamic Injury to Evaluate Weight Reduction and Safety Over 4 Weeks Followed by an 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
- 14
- 试验地点
- 4
- 主要终点
- 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 of beloranib in obese subjects with hypothalamic injury.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by BMI ≥30 and ≤60 kg/m2
- •Greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary
- •Stable body weight for at least 3 months
- •Type 2 diabetes mellitus is allowed
排除标准
- •Males taking gonadotropin replacement therapy (LH/FSH)
- •Subjects who are planning any fertility treatment within 6 months of study participation
- •Use of weight loss agents, including herbal medications, in the past 3 months
- •Current or anticipated chronic use of narcotics or opiates
- •History of severe psychiatric disorders
- •Type 1 diabetes mellitus
- •Metabolic disorders or genetic disorders linked to obesity
- •History of any bariatric surgery
- •Participation in any clinical study with an investigational drug or device within the 3 months prior to enrollment in this study
- •Blood loss or donation >500 mL within the past 3 months
- •Females who are pregnant, nursing, intend to become pregnant during the study or any males who plan to father/conceive a child within 6 months after completion of study participation
研究组 & 干预措施
ZGN-440 sterile diluent
Placebo Comparator
Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks.
干预措施: ZGN-440 sterile diluent (Drug)
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: ZGN-440 for injectable suspension (Drug)
结局指标
主要结局
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 lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period(4 weeks)
- Change in hs-CRP from baseline to the end of the randomized dosing period.(4 weeks)
- Change in hunger from baseline to the end of the randomized dosing period.(4 weeks)
- Change in quality of life from baseline to the end of the randomized dosing period.(4 weeks)
研究者
研究点 (4)
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