A randomised, double-blind, parallel group, placebo-controlled trial comparing semaglutide 2.4 mgwith semaglutide placebo both administered s.c. once-weekly in subjects with established CVdisease and overweight or obesity
- Conditions
- Health Condition 1: I30-I52- Other forms of heart diseaseHealth Condition 2: E66- Overweight and obesityHealth Condition 3: E66- Overweight and obesity
- Registration Number
- CTRI/2018/10/016193
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method