CTRI/2018/10/016193进行中（未招募）3 期
Semaglutide effects on cardiovascular outcomes in people with overweight or obesity
ovo Nordisk AS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. 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
- •2. Male or female, age more than or equal to 45 years at the time of signing informed consent
- •3. Body mass index more than or equal to 27 kg per m2.
- •4. 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:
- •1. 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
- •2. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •3. Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
- •Glycaemia-related:
- •4. HbA1c more than or equal to48 mmolpermol -6.5 percent as measured by the central laboratory at screening
- •5. History of type 1 or type 2 diabetes -history of gestational diabetes is allowed.
- •6. Treatment with glucose-lowering agents within 90 days before screening
- •7. Treatment with any GLP-1 RA within 90 days before screening
- •General safety:
- •8. History or presence of chronic pancreatitis
- •9. Presence of acute pancreatitis within the past 180 days prior to the day of screening
- •10. Personal or first degree relatives history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- •11. End stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis
- •12. 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
- •13. Severe psychiatric disorder which in the investigator’s opinion could compromise compliance with the protocol
- •14. Known or suspected hypersensitivity to trial products or related products
- •15. Previous participation in this trial. Participation is defined as randomisation
- •16. Receipt of any investigational medicinal product within 30 days before screening
- •17. 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
- •18. Any disorder, unwillingness or inability, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol
研究者
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