Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
45–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 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
You may not be if
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 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)
Treatment with glucose-lowering agents within 90 days before screening
Treatment with any glucagon-like-peptide-1 receptor agonist (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 relative(s) 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 participant's safety or compliance with the protocol
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