Effect and Safety of Semaglutide Once-weekly in East Asian Subjects With Overweight or Obesity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- Change in Body Weight (%)
研究概览
简要总结
This study will look at the change in participants' body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a half years. Participants will have 14 clinic visits and 11 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)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 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
- •BMI more than or equal to 27.0 kg/m^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D)
- •History of at least one self-reported unsuccessful dietary effort to lose body weight
- •For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
排除标准
- •A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- •For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
- •For subjects with T2D at screening (Japan only): a) Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m^2 (less than 60 mL/min/1.73 m^2 in subjects treated with sodium-glucose co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation
研究组 & 干预措施
Semaglutide 2.4 mg
Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue semaglutide 2.4 mg until week 68.
干预措施: Semaglutide (Drug)
Placebo (semaglutide 2.4 mg)
Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue placebo (semaglutide 2.4 mg) until week 68.
干预措施: Placebo (semaglutide) (Drug)
Semaglutide 1.7 mg
Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue semaglutide 1.7 mg until week 68.
干预措施: Semaglutide (Drug)
Placebo (semaglutide 1.7 mg)
Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue placebo (semaglutide 1.7) until week 68.
干预措施: Placebo (semaglutide) (Drug)
结局指标
主要结局
Change in Body Weight (%)
时间窗: Baseline (week 0), week 68
Change from baseline (week 0) in body weight for 'in-trial' observation period at week 68 is presented. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).
Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%
时间窗: At week 68
Number of participants who achieved greater than or equal to (≥) 5% weight loss at week 68 for in-trial observation period 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. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).
次要结局
- Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%(At week 68)
- Change in Visceral Fat Area (VFA) (%)(Baseline (week 0) to week 68)
- Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest(Baseline (week 0) to week 68)
- Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline(Baseline (week 0) to week 68)
- Change in Diastolic Blood Pressure(Baseline (week 0) to week 68)
- Change in Free Fatty Acids-ratio to Baseline(Baseline (week 0) to week 68)
- Change in Lipase: Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Calcitonin: Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Body Mass Index (BMI)(Baseline (week 0) to week 68)
- Change in Visceral Fat Area (VFA) Centimeter Square (cm^2)(Baseline (week 0) to week 68)
- Change in Fasting Serum Insulin-ratio to Baseline(Baseline (week 0) to week 68)
- Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%(At week 68)
- Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%(At week 68)
- Change in Body Weight (Kg)(Baseline (week 0) to week 68)
- Change in HbA1c (%)(Baseline (week 0) to week 68)
- Change in HbA1c (mmol/Mol)(Baseline (week 0) to week 68)
- Change in Fasting Plasma Glucose(Baseline (week 0) to week 68)
- Change in Systolic Blood Pressure(Baseline (week 0) to week 68)
- Change in Low-density Lipoproteins (LDL)-Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Total Cholesterol-ratio to Baseline(Baseline (week 0) to week 68)
- Change in High-density Lipoproteins (HDL)-Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Very Low-density Lipoproteins (VLDL)-Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Triglycerides-ratio to Baseline(Baseline (week 0) to week 68)
- Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Plasminogen Activator Inhibitor-1 Activity-ratio to Baseline(Baseline (week 0) to week 68)
- Change in Short Form 36 v2.0 Acute (SF-36) Score(Baseline (week 0) to week 68)
- Change in Impact of Weight on Quality of Life-lite for Clinical Trials (IWQOL-Lite for CT) Score(Baseline (week 0) to week 68)
- Number of Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score(At week 68)
- Number of Participants Who Achieve (Yes/no): Responder Definition Value for IWQoL-Lite for CT Physical Function (5-items) Score(At week 68)
- Number of Participants Who Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol)(At week 68)
- Number of Participants Who Achieved (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)(At week 68)
- Number of Treatment-emergent AEs(Week 0 to week 75)
- Number of Serious Adverse Events(Week 0 to week 75)
- Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes(Week 0 to week 75)
- Change in Pulse(Baseline (week 0) to week 68)
- Change in Amylase: Ratio to Baseline(Baseline (week 0) to week 68)
- Change in QTCF Interval(Baseline (week 0) to week 68)