Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%
研究概览
简要总结
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.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Semaglutide
Participants will receive semaglutide 2.4 mg during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.
干预措施: Semaglutide (Drug)
Placebo
Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.
干预措施: Placebo (Semaglutide) (Drug)
结局指标
主要结局
Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%
时间窗: At Week 104
Number of participants who achieved greater than or equal to (\>=) 5% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved \>=5% weight loss, whereas 'No' infers the number of participants who have not achieved \>=5% weight loss. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment).
Percentage Change From Baseline (Week 0) to Week 104 in Body Weight
时间窗: From Baseline (Week 0) to Week 104
Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment).
次要结局
- Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%(At Week 104)
- Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure(From Baseline (Week 0) to Week 104)
- Change From Baseline (Week 0) to Week 104 in Waist Circumference(From Baseline (Week 0) to Week 104)
- Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline(From Baseline (Week 0) to Week 104)
- Change in Glycated Haemoglobin (HbA1c) (Percent [%])(From Baseline (Week 0) to Week 104)
- Percentage Change From Baseline (Week 0) to Week 52 in Body Weight(From Baseline (Week 0) to Week 52)
- Change From Baseline (Week 0) to Week 52 in Body Weight (kg)(From Baseline (Week 0) to Week 52)
- Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%(At Week 52)
- Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%(At Week 52)
- Change From Baseline (Week 0) to Week 104 in Lipase(From Baseline (Week 0) to Week 104)
- Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%(At Week 104)
- Change From Baseline (Week 0) to Week 104 in Body Weight (kg)(From Baseline (Week 0) to Week 104)
- Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI)(From Baseline (Week 0) to Week 104)
- Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure(From Baseline (Week 0) to Week 104)
- Change in Total Cholesterol-ratio to Baseline(From Baseline (Week 0) to Week 104)
- Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline(From Baseline (Week 0) to Week 104)
- Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%(At Week 104)
- Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L)(From Baseline (Week 0) to Week 104)
- Number of Serious Adverse Events (SAEs)(From Baseline (Week 0) to Week 111)
- Change From Baseline (Week 0) to Week 52 in Waist Circumference(From Baseline (Week 0) to Week 52)
- Number of Treatment-emergent Adverse Events (TEAEs)(From Baseline (Week 0) to Week 111)
- Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline(From Baseline (Week 0) to Week 104)
- Change in Free Fatty Acids-ratio to Baseline(From Baseline (Week 0) to Week 104)
- Change in Triglycerides-ratio to Baseline(From Baseline (Week 0) to Week 104)
- Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline(From Baseline (Week 0) to Week 104)
- Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol)(From Baseline (Week 0) to Week 104)
- Change From Baseline (Week 0) to Week 104 in FPG (mg/dL)(From Baseline (Week 0) to Week 104)
- Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL)(From Baseline (Week 0) to Week 104)
- Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI)(From Baseline (Week 0) to Week 52)
- Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%(At Week 52)
- Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%(At Week 52)
- Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L)(From Baseline (Week 0) to Week 104)
- Change From Baseline (Week 0) to Week 104 in Amylase(From Baseline (Week 0) to Week 104)
- Change From Baseline (Week 0) to Week 104 in Calcitonin(From Baseline (Week 0) to Week 104)
- Change From Baseline (Week 0) to Week 104 in Pulse(From Baseline (Week 0) to Week 104)