Clinical Trial Services, Corp | Miami, FL
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About
This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years.
Enrollment
Sex
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Volunteers
Inclusion criteria
Male or female
Age above or equal to 55 years at the time of signing informed consent
Body mass index (BMI) greater than or equal to (>=) 25.0 kilograms per meter square (kg/m^2)
Established CVD as evidenced by at least one of the following:
Prior myocardial infarction
Prior stroke (ischemic or haemorrhagic stroke)
Symptomatic peripheral arterial disease (PAD) defined as at least one of the following:
For participants with T2D at screening the following inclusion criteria also apply:
Diagnosed with type 2 diabetes mellitus (T2D) >= 180 days before screening
HbA1c 6.5%-10% (48-86 millimoles per mole [mmol/mol]) (both inclusive), as measured by central laboratory at screening
Treatment with either:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
7,000 participants in 2 patient groups, including a placebo group
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Central trial contact
Novo Nordisk
Data sourced from clinicaltrials.gov
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