NCT00779519已完成2 期
A Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multiple Dose, Multicenter Study to Assess Safety and Tolerability of TTP435 in Obese (Class 1-2) Subjects Over 8 Weeks of Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Participant Adverse Events
研究概览
简要总结
Multiple pathways including peripheral and central hormones and neurotransmitters are involved in the regulation of food intake and body weight. One of the most studied pathways involves the melanocortin receptor. Agouti-related protein (AgRP) and alpha-melanocyte stimulating hormone (alphaMSH)have been shown to play an integral role in food intake and body weight.
It is reasonable to speculate that if there is an imbalance of alphaMSH and AgRP exist in obese individuals and inhibiting the activity of AgRP may be of therapeutic benefit in treating obesity.
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
- Double (Participant, Investigator)
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
- 是
入选标准
- •Male or female volunteers, aged 18 to 65 years, inclusive.
- •Subjects must be obese (class 1: BMI of 30.0 to 34.9 kg/m2 or class 2: BMI of 35 to 39.9 kg/m2 in non-Asians and BMI of 27.0 - 31.9 kg/m2 or 32.0 - 36.9 kg/m2 in Asians) at the Screening Visit.
- •Female subjects must be postmenopausal (with amenorrhea for at least 2 years prior to scheduled dosing and confirmatory FSH test in the range of 23-116 IU/L) or surgically sterile (with physician or insurance documentation of bilateral tubal ligation at least 6 months prior to Screening Visit or of a hysterectomy and/or bilateral oophorectomy) and agree not to undergo in vitro fertilization during the study and for 6 months post treatment.
排除标准
- •Type 1 diabetes.
- •Type 2 diabetes.
- •History of myocardial infarction, stroke, including transient ischemic attack, in the last 2 years.
- •Asthma or chronic obstructive pulmonary disease controlled by regular use of inhaled steroids.
- •Subjects with rheumatoid arthritis, lupus, or multiple sclerosis regularly requiring steroids or disease-modifying anti-rheumatic agents.
- •Subjects with psoriasis requiring oral steroids.
- •Subjects planning to undergo gastric bypass or resection surgery, or who have had such a procedure in the 6 months prior to the Screening Visit.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
TTP435
Experimental
干预措施: TTP435 (Drug)
结局指标
主要结局
Participant Adverse Events
时间窗: Day 1 to Day 70 (2 weeks post dose)
次要结局
- Change from Baseline Glucose Levels(Day 1 to Day 70 (2 weeks post dose))
- Absolute Change in Body Weight(Day 1 to Day 70 (2 weeks post dose))
- Absolute Change in Body Mass Index(Day 1 to Day 70 (2 weeks post dose))
- Percent Change in Body Weight After 8 Weeks of Treatment with TTP435 or Placebo(Day 1 to Day 70 (2 weeks post dose))
- Effect Subject-reported Satiety(Day 1 to Day 70 (2 weeks post dose))
- Change from Baseline Insulin Levels(Day 1 to Day 70 (2 weeks post dose))
- Change from Baseline Free Fatty Acid Levels(Day 1 to Day 70 (2 weeks post dose))
- Change from Baseline Leptin Levels(Day 1 to Day 70 (2 weeks post dose))
研究者
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