Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity



Status:Recruiting
Conditions:Obesity Weight Loss, Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:45 - Any
Updated:4/4/2019
Start Date:October 24, 2018
End Date:September 28, 2023
Contact:Novo Nordisk
Email:clinicaltrials@novonordisk.com
Phone:(+1) 866-867-7178

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SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity

The researchers are doing the study to see if semaglutide may reduce the risk of having
cardiovascular events in patients with overweight or obesity and with prior cardiovascular
disease. The participant will either get semaglutide (active medicine) or placebo ("dummy"
medicine). Which treatment the participants get is decided by chance. The participant's
chance of getting semaglutide or placebo is the same. The participant will get the study
medicine in a pen. The participants will need to use the pen to inject the study medicine in
a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have
up to 25 clinic visits with the study doctor.


Inclusion Criteria: - Male or female, age greater than or equal to 45 years at the time of
signing informed consent - Body mass index (BMI) greater than or equal to 27 kg/m^2 - Have
established cardiovascular (CV) disease as evidenced by at least one of the following:
prior myocardial infarction; prior stroke (ischemic or haemorrhagic stroke); or symptomatic
peripheral arterial disease (PAD), as evidenced by intermittent claudication with
ankle-brachial index (ABI) less than 0.85 (at rest), or peripheral arterial
revascularization procedure, or amputation due to atherosclerotic disease Exclusion
Criteria: - 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 - HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the
central laboratory at screening - History of type 1 or type 2 diabetes (history of
gestational diabetes is allowed)
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Kingsport, Tennessee 37660
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