Semaglutide effects on cardiovascular outcomes in people with overweight or obesity
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 17,500
- 试验地点
- 35
- 主要终点
- consisting of: CV death, non-fatal myocardial infarction, or non-fatal stroke
研究概览
简要总结
This is a randomised, double-blind, parallel group, placebo-controlled trial comparing semaglutide 2.4 mg with semaglutide placebo both administered s.c. once-weekly in subjects with established CV disease and overweight or obesity. Subjects will be randomised in a 1:1 ratio to receive either semaglutide 2.4 mg or semaglutide placebo as an adjunct to standard-of-care. The trial is event driven with trial closure being performed when the targeted number of primary endpoint events has been reached. An independent Data Monitoring Committee (DMC) will oversee subject safety and may recommend stopping the trial early. With the assumed event rate and a recruitment period of 28 months, the estimated trial duration will be 59 months from start of randomisation to end of follow-up of the last subject,including 28 months of recruitment and 7 weeks of follow-up. Estimated trial duration for an individual subject is from 31 to 59 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent obtained before any trial-related activities.
- •Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •Male or female, age more than or equal to 45 years at the time of signing informed consent
- •Body mass index more than or equal to 27 kg per m
- •Have established CV disease as evidenced by at least one of the following: a.
- •prior myocardial infarction b.
- •prior stroke (ischemic or hemorrhagic stroke) c.
- •symptomatic peripheral arterial disease, as evidenced by intermittent claudication with ankle-brachial index less than 0.85 at rest , or peripheral arterialrevascularization procedure, or amputation due to atherosclerotic disease.
排除标准
- •Cardiovascular-related:
- •Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •Presently classified as being in New York Heart Association (NYHA) Class IV heart failure Glycaemia-related:
- •HbA1c more than or equal to48 mmolpermol -6.5 percent as measured by the central laboratory at screening
- •History of type 1 or type 2 diabetes -history of gestational diabetes is allowed.
- •Treatment with glucose-lowering agents within 90 days before screening
- •Treatment with any GLP-1 RA within 90 days before screening General safety:
- •History or presence of chronic pancreatitis
- •Presence of acute pancreatitis within the past 180 days prior to the day of screening
- •Personal or first degree relatives history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- •End stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis
- •Presence or history of malignant neoplasms within the past 5 years prior to the day of screening Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
- •Severe psychiatric disorder which in the investigator’s opinion could compromise compliance with the protocol
- •Known or suspected hypersensitivity to trial products or related products
- •Previous participation in this trial.
- •Participation is defined as randomisation
- •Receipt of any investigational medicinal product within 30 days before screening
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
- •Any disorder, unwillingness or inability, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol.
结局指标
主要结局
consisting of: CV death, non-fatal myocardial infarction, or non-fatal stroke
时间窗: upto 59 months
The primary endpoint is time from randomisation to first occurrence of a composite endpoint
时间窗: upto 59 months
次要结局
- Time from randomisation to:(CV death)
- Time from randomisation to first occurrence of:(Non-fatal myocardial infarction)
- Change from randomisation to year 2 (visit14) in:(Systolic blood pressure (mmHg))