TM30339: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Repeated Subcutaneous Dose-range Study Designed to Determine the Weight Loss in Obese Subjects.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 192
- 主要终点
- The primary endpoint is the change in body weight from baseline (Visit 1) to Visit 5 (the 29th day),which will be computed for each patient and then averaged for each dose arm.
研究概览
简要总结
The purpose of this study is to determine the effects of TM30339 on weight loss in obese individuals after 28 days dosing.
详细描述
Obesity is a disease with large socioeconomic consequences and many serious health consequences including Type 2 diabetes, dyslipidemia and cardiovascular diseases. The prevalence of obesity is increasing both in developed and developing countries. There is a great need for further medicinal treatments that effectively will support life style changes or surgical procedures in reducing or maintaining bodyweight.
7TM Pharma has identified TM30339 as a clinical development candidate molecule with potential to assist in the control and amelioration of obesity in humans.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese males and females with a BMI of 30-40 kg/m2 inclusive and weight in the range of 85 - 135 kg inclusive
- •Age 18-60 years inclusive
- •Stable lifestyle e.g. smoking, exercise and eating patterns and times for at least 6 months, and willing to maintain these habits during the course of the study
- •Stable weight over past 2 months i.e. a change in body weight < 3 kg as reported by the subject
排除标准
- •Subjects with a history of allergies toward products containing natural rubber (e.g. latex)
- •Subjects with, or with a history of, any clinically significant neurological, gastrointestinal (including bariatric surgery), renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, or other major disorders
- •Subjects who have a supine blood pressure at screening or Visit 1 higher than 150/95 mmHg by repeat measurements within 15 minutes
- •Subjects who have a QTc (Bazett's correction) interval of > 450 msec at screening
- •Subjects with bradycardia (heart rate < 50)
- •Subjects with heart block
- •Clinically significant thyroid dysfunction as evidenced by TSH > 1.5 X ULN
研究组 & 干预措施
1
AM dose: 0.85 mg
PM dose: placebo
干预措施: TM30339 and/or placebo (Drug)
2
AM dose: 0.85 mg
PM dose: 0.85 mg
干预措施: TM30339 and/or placebo (Drug)
3
AM dose: 2.55 mg
PM dose: placebo
干预措施: TM30339 and/or placebo (Drug)
4
AM dose: placebo
PM dose: 2.55 mg
干预措施: TM30339 and/or placebo (Drug)
5
AM dose: 2.55 mg
PM dose: 2.55 mg
干预措施: TM30339 and/or placebo (Drug)
6
AM dose: placebo
PM dose: placebo
干预措施: TM30339 and/or placebo (Drug)
结局指标
主要结局
The primary endpoint is the change in body weight from baseline (Visit 1) to Visit 5 (the 29th day),which will be computed for each patient and then averaged for each dose arm.
时间窗: Visit 5 (the 29th day)
次要结局
- To determine the effects of TM30339 after 28 days dosing of obese individuals on: Waist, hip, and waist/hip ratio(Visit 5 (the 29th day))
- To determine the effects of TM30339 after 28 days dosing of obese individuals on fasting glucose and insulin, and insulin sensitivity index(Visit 5 (the 29th day))
- To determine the effects of TM30339 after 28 days dosing of obese individuals on formation of antibodies towards the drug, TM30339(Visit 5 (the 29th day))
- To determine the effects of TM30339 after 28 days dosing of obese individuals on safety and tolerability(Visit 5 (the 29th day))