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Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

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合作者:
信息的提供 (责任方):
October 1, 2018
October 3, 2018
October 3, 2018
October 5, 2018
January 29, 2021   (主要结果测量的最终数据收集日期)
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

与当前相同
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 10%[ Time Frame: Week 0, week 104 ]
    Number of subjects
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 15%[ Time Frame: Week 0, week 104 ]
    Number of subjects
  • Change in waist circumference[ Time Frame: Week 0, week 104 ]
    Measured in cm
  • Change in systolic blood pressure[ Time Frame: Week 0, week 104 ]
    Measured in mmHg
  • Change in body weight[ Time Frame: Week 0, week 104 ]
    Measured in kg
  • Change in body mass index (BMI)[ Time Frame: Week 0, week 104 ]
    Measured in kg/m^2
  • Change in hemoglobin A1c (HbA1c)[ Time Frame: Week 0, week 104 ]
    Measured in %
  • Change in HbA1c[ Time Frame: Week 0, week 104 ]
    Measured in mmol/mol
  • Change in fasting plasma glucose[ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in fasting serum insulin[ Time Frame: Week 0, week 104 ]
    Measured in micro IU/mL
  • Change in diastolic blood pressure[ Time Frame: Week 0, week 104 ]
    Measured in mmHg
  • Change in total cholesterol[ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in high density lipoprotein (HDL) cholesterol[ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in low density lipoprotein (LDL) cholesterol[ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in very low density lipoprotein (VLDL) cholesterol[ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in free fatty acids[ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in triglycerides[ Time Frame: Week 0, week 104 ]
    Measured in mg/dL
  • Change in high sensitivity C-Reactive Protein[ Time Frame: Week 0, week 104 ]
    Measured in mg/L
  • Change in body weight[ Time Frame: Week 0, week 52 ]
    Measured in %
  • Change in body weight[ Time Frame: Week 0, week 52 ]
    Measured in kg
  • Change in BMI[ Time Frame: Week 0, week 52 ]
    Measured in kg/m^2
  • Change in waist circumference[ Time Frame: Week 0, week 52 ]
    Measured in cm
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 5%[ Time Frame: Week 0, week 52 ]
    Number of subjects
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 10%[ Time Frame: Week 0, week 52 ]
    Number of subjects
  • Subjects who achieve (yes/no): body weight reduction more than or equal to 15%[ Time Frame: Week 0, week 52 ]
    Number of subjects
  • Number of treatment-emergent adverse events (TEAEs)[ Time Frame: Week 0, week 111 ]
    Number of events
  • Number of serious adverse events (SAEs)[ Time Frame: Week 0, week 111 ]
    Number of events
  • Change in pulse[ Time Frame: Week 0, week 104 ]
    Measured in beats per minute
  • Change in amylase[ Time Frame: Week 0, week 104 ]
    Measured in U/L
  • Change in lipase[ Time Frame: Week 0, week 104 ]
    Measured in U/L
  • Change in calcitonin[ Time Frame: Week 0, week 104 ]
    Measured in ng/L
 
Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity

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.

Interventional
Phase 3
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
  • Drug: Semaglutide
    Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks
  • Drug: Placebo (Semaglutide)
    S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks
  • Experimental: Semaglutide
    Participants will receive semaglutide 2.4 mg during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.
  • Placebo Comparator: Placebo
    Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.
 
Not yet recruiting
88
与当前相同
March 19, 2021
January 29, 2021   (主要结果测量的最终数据收集日期)
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
参与研究的性别: All
最小年龄:18 Years ,最大年龄:N/A  
没有
Hungary|Italy|Spain|United States
 
No
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
计划分享 IPD: Yes
Novo Nordisk A/S
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
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
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