Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of ZGN-1061 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Glycemic Control, Safety, and Tolerability Over 12 Weeks
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Zafgen, Inc.
- 入组人数
- 188
- 试验地点
- 23
- 主要终点
- Safety and tolerability as assessed by incidence of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.
详细描述
Participants will be enrolled in 1 of 2 groups. Approximately 120 participants will receive 0.05, 0.3, or 0.9 mg of ZGN-1061 or placebo (Group 1). An additional 40 participants will receive 0.9 or 1.8 mg of ZGN-1061 or placebo (Group 2).
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the following criteria to participate in this study:
- •Be between the ages of 18 and 70 years, inclusive.
- •Overweight or obese with a body mass index of at least 27 kg/m².
- •Have type 2 diabetes with HbA1c between 7% and 11%.
- •For subjects taking approved antidiabetes medications, the doses must be stable as determined by the study doctor.
- •For subjects who have had weight-loss surgery (example: gastric banding), the procedure must have occurred at least 1 year ago, and be verified with documentation or by a health professional associated with the surgery.
排除标准
- •Subjects cannot participate in this research study if they meet any of the following:
- •Have taken another study drug or study device within the past 6 months.
- •Are taking certain prescribed medications including narcotics or opiates.
- •Consistent recent use of insulin.
- •Have had recent major surgery or prolonged bed rest, or planning or likely to undergo any surgery during the research study.
- •Have a history of bleeding disorders or risk factors for excessive blood clotting.
- •Have difficulty giving blood.
- •Have a history of drug and/or alcohol abuse.
研究组 & 干预措施
0.05 mg ZGN-1061 (A)
0.05 mg ZGN-1061 subcutaneous injection once every 3 days
干预措施: ZGN-1061 (Drug)
0.3 mg ZGN-1061 (B)
0.3 mg ZGN-1061 subcutaneous injection once every 3 days
干预措施: ZGN-1061 (Drug)
0.9 mg ZGN-1061 (C)
0.9 mg ZGN-1061 subcutaneous injection once every 3 days
干预措施: ZGN-1061 (Drug)
1.8 mg ZGN-1061 (CC)
1.8 mg ZGN-1061 subcutaneous injection once every 3 days
干预措施: ZGN-1061 (Drug)
Placebo (D)
Placebo subcutaneous injection once every 3 days
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability as assessed by incidence of adverse events
时间窗: 12 weeks
Change in HbA1c
时间窗: 12 weeks
Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results
时间窗: 12 weeks
次要结局
- Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects(12 weeks)
- Change in fasting plasma glucose(12 weeks)
- Change in glucagon(12 weeks)
- Change in beta-cell function(12 weeks)
- Change in insulin sensitivity(12 weeks)
- Change in insulin(12 weeks)
- Change in body weight(12 weeks)
- Proportion of subjects achieving HbA1c <7% and ≤6.5%(12 weeks)
- Change in C-peptide(12 weeks)
- Change in waist and hip circumference(12 weeks)
- Change in patient reported outcomes measures(12 weeks)
- Change in proinsulin(12 weeks)
- Change in biomarkers relevant to obesity and/or type 2 diabetes(12 weeks)