Health Condition 1: I30-I52- Other forms of heart disease Health Condition 2: E66- Overweight and obesity Health Condition 3: E66- Overweight and obesity
Conditions
Interventions
Intervention1: Semaglutide: Dose: Subjects will be initiated at a once-weekly dose of 0.24 mg s.c. and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0,
Sponsors
Novo Nordisk AS
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is time from randomisation to first occurrence of a composite endpoint consisting of: CV death, non-fatal myocardial infarction, or non-fatal strokeTimepoint: upto 59 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from randomisation to year 2 (visit14) in: Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg) Pulse (bpm) High sensitivity C-Reactive Protein (hsCRP) (mg/L) Lipids (mg/dL) Total cholesterol High density lipoprotein (HDL) cholesterol Low density lipoprotein (LDL) cholesterol Triglycerides Body weight (%) Waist circumference (cm) Patient reported outcomes HbA1c (%, mmol /mol) change from screening (visit 1) to year 2 (visit 14) Timepoint: upto 59 months;Time from randomisation to first occurrence of: An expanded composite CV endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or unstable angina requiring hospitalisation A composite heart failure endpoint consisting of: heart failure hospitalisation, urgent heart failure visit or CV death A composite endpoint consisting of: all-cause death, non-fatal myocardial infarction, or nonfatal strokeTimepoint: upto 59 months;Time from randomisation to first occurrence of: Non-fatal myocardial infarction Non-fatal stroke Coronary revascularisation Unstable angina requiring hospitalisation Heart failure hospitalisation or urgent heart failure visit HbA1c more than or equal to 48 mmol per mol (6.5 percent) A 5-component composite nephropathy endpoint Timepoint: upto 59 months;Time from randomisation to: CV death All-cause deathTimepoint: upto 59 months | — |
Countries
Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactMaya Sharma
Novo Nordisk India Private Ltd.
Outcome results
None listed