REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels

About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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:

Intermittent claudication with an ankle-brachial index (ABI) less than (<) 0.85 at rest
Intermittent claudication with a >= 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computed tomography (CT) angiography or Doppler ultrasound
Prior revascularization procedure of a lower extremity peripheral artery
Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)

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:

Lifestyle intervention alone
1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), dipeptidyl peptidase 4 (DPP4)-inhibitors, thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local label
Basal insulin alone or in combination with up to two marketed OADs, all according to local label

EXCLUSION CRITERIA

Exclusion Criteria:

Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 60 days before screening
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Heart failure classified as being in New York Heart Association (NYHA) Class IV at screening
Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or a medication with GLP-1 activity within 90 days before screening
End stage renal disease defined as estimated glomerular filtration rate (eGFR) < 15 millileters per minutes per 1.73^2 (mL/min/1.73 m^2), as measured by the central laboratory at screening
Chronic or intermittent haemodialysis or peritoneal dialysis