NCT02324491终止2 期
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Weight Reduction, Glycemic Control, Safety, and Tolerability
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Zafgen, Inc.
- 入组人数
- 152
- 试验地点
- 16
- 主要终点
- Change in 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 adult subjects with type 2 diabetes mellitus.
详细描述
Phase 2, randomized, double-blind, placebo-controlled, parallel dose arms study with 12-month randomized treatment.
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
- •Obese with BMI ≥30 kg/m2
- •Type 2 diabetes mellitus
- •HbA1c of 7-11%
- •Fasting glucose <15.5 mmol/L
- •Treated with diet and exercise alone or with a stable regimen of metformin, sulfonylurea, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist, SGLT-2 inhibitor or any combination of these agents
- •Female subjects must be surgically sterile, post-menopausal or using long-acting contraception, which includes intrauterine devices or use of an implanted or injectable contraceptive
排除标准
- •Current or recent use of insulin
- •Severe hypoglycemia within the prior 6 months
- •Metabolic disorders or genetic disorders linked to obesity (e.g., Prader-Willi Syndrome)
研究组 & 干预措施
ZGN-440 Injectable Suspension (1.2mg)
Experimental
ZGN-440 for Injectable Suspension
干预措施: ZGN-440 for Injectable Suspension (Drug)
ZGN-440 Injectable Suspension (1.8mg)
Experimental
ZGN-440 for Injectable Suspension
干预措施: ZGN-440 for Injectable Suspension (Drug)
Placebo
Placebo Comparator
ZGN-440 Placebo for Injectable Suspension
干预措施: ZGN-440 Placebo for Injectable Suspension (Drug)
结局指标
主要结局
Change in body weight
时间窗: Baseline to Week 26
Safety and tolerability assessed by adverse events, laboratory evaluations, ECGs, vital signs, physical examinations
时间窗: Baseline to Week 26 and Week 52
次要结局
- Change in body weight(Baseline to Week 52)
- Change in fasting glycemic parameters(Baseline to Week 26 and Week 52)
- Change in cardiometabolic parameters(Baseline to Week 26 and Week 52)
- Change in Patient Reported Outcomes (PRO) scores(Baseline to Week 26 and Week 52)
研究者
研究点 (16)
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