NCT00665665终止1 期
Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Healthy Male and Female Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses
研究概览
简要总结
This trial will be conducted in the United States of America (USA). The aim of the trial is to investigate whether the drug is safe, well tolerated and to investigate the efficacy of NNC 0070-0002-0182 for the treatment of obesity. The subjects will be treated with drug and placebo. This registration covers the phase 2 part of a combined phase 1/phase 2 trial (phase 1 part of trial conducted between November 2007 and April 2008).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 30.0-39.0 kg/m2 (obese)
- •Females who consent to using double barrier method of contraception, are post-menopausal and older than 50 years, or have had total hysterectomy
排除标准
- •Clinically significant diseases
- •Blood pressure greater than 140/90 mmHg
- •Evidence of depression
- •Recent diet attempts, treatment with diet drugs (within 3 months)
- •Liposuction or other surgery for weight loss within the last year
- •Evidence of eating disorders (bulimia, binge eating)
- •Restricted diets (Kosher, vegetarian)
- •Smoker or history of drug or alcohol abuse
- •Females of childbearing potential: positive pregnancy test
研究组 & 干预措施
A
Experimental
干预措施: placebo (Drug)
A
Experimental
干预措施: NNC 0070-0002-0182 (Drug)
B
Experimental
干预措施: placebo (Drug)
B
Experimental
干预措施: NNC 0070-0002-0182 (Drug)
C
Experimental
干预措施: placebo (Drug)
C
Experimental
干预措施: NNC 0070-0002-0182 (Drug)
D
Experimental
干预措施: placebo (Drug)
D
Experimental
干预措施: NNC 0070-0002-0182 (Drug)
结局指标
主要结局
To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses
时间窗: after 6 weeks
次要结局
- Pharmacokinetics of NNC 0070-0002-0182 and its isomer(at 8 weeks)
- Assessment of changes in food consumption and hunger(at 6 weeks)
- Change in weight, waist and hip measurements and mood(at 6 weeks)
- Change in body composition and resting metabolism(at 6 weeks)
- Intervention arm D only: Change from baseline in body fat (DEXA)(at 6 weeks)
- Intervention arm D only: Change from baseline in indirect calorimetry(at 6 weeks)
- Intervention arm D only: Change in insulin sensitivity (HOMA)(at 6 weeks)
- Intervention arm D only: Change from baseline in adiponectin, hsCRP(at 6 weeks)
- Intervention arm D only: Antibody assessment(at 10 weeks)
研究者
研究点 (1)
Loading locations...
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