A Randomized, Double-Blind, Placebo-Controlled, Two Part Trial (Sequential Single Subcutaneous Dose Rising Trial and Semi-Sequential Multiple Subcutaneous Dose Response Trial) to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0453 in Overweight/Obese Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Number and severity of adverse events
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the trial drug is eliminated from the body) of NNC 0070-0002-0453 in overweight/obese, but otherwise healthy male and female volunteers. Selected subjects will continue in a follow-up period of up to 5 years.
详细描述
Due to an unfavourable benefit-risk profile observed during the phase 1 trial for the obesity project, NN9161, Novo Nordisk has decided to terminate further clinical development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •FOR TRIAL PART 1, THE FOLLOWING APPLIES:
- •Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject
- •Overweight/obese males: Body Mass Index (BMI) between 27.0 to 39.0 kg/m2
- •Good general health
- •FOR TRIAL PART 2, THE FOLLOWING APPLIES:
- •Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject.
- •Obese male and female subjects: Body Mass Index (BMI) between 30.0 to 39.0 kg/m2
- •Good general health.
排除标准
- •Aggressive diet attempts within the last 3 months
- •Current or history of treatment with medications that may cause significant weight gain
- •History of major depressive disorder or history of a suicide attempt or history of any suicidal behaviour
- •History of eating disorders
- •Any weight change of 5 kg (11 pounds) in the last 3 months
- •Tobacco use
- •History of alcoholism or drug/chemical abuse
研究组 & 干预措施
Trial, part 1 (males only)
干预措施: NNC 0070-0002-0453 (Drug)
Trial, part 1 (males only)
干预措施: placebo (Drug)
Trial, part 2 (males and females)
干预措施: '2-0453 (Drug)
Trial, part 2 (males and females)
干预措施: placebo (Drug)
结局指标
主要结局
Number and severity of adverse events
时间窗: From the first trial related activity (Day 1) and until completion of the post treatment follow-up visit (Day 22 +/- 1)
次要结局
- AUC 0-24h, area under the '2-453 concentration-time curve(From 0 to 24 hours after steady state)
- Terminal half-life (t½)(After administration of a single dose of trial drug)