Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
追踪信息 | |||
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首次提交日期 ICMJE | October 1, 2018 | ||
首次发布日期e ICMJE | October 3, 2018 | ||
最后更新发布日期 | October 3, 2018 | ||
预计研究开始日期 ICMJE | October 5, 2018 | ||
预计主要完成日期 | January 29, 2021 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Change in body weight[ Time Frame: Week 0, week 104 ] Measured in % Subjects who achieve (yes/no): body weight reduction more than or equal to 5%[ Time Frame: Week 0, week 104 ] Number of subjects |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity | ||
正式标题 ICMJE | Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity | ||
简要概况 | This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | Phase 3 | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
88 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | March 19, 2021 | ||
预计主要完成日期 | January 29, 2021 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Male or female, age more than or equal to 18 years at the time of signing informed consent - Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease - History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion criteria: - HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening - A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Hungary|Italy|Spain|United States | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | Novo Nordisk A/S | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | |||
验证日期 | September 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |