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

Novo Nordisk

Status and phase: Enrolling; Phase 3

Conditions: Cardiovascular Disease

Treatments: Drug: Semaglutide; Drug: Cagrilintide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05669755

jRCT2031220672 (Registry Identifier)

2021-005855-35 (EudraCT Number)

U1111-1270-0943 (Other Identifier)

NN9838-4942

Details and patient eligibility

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: 7,000 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy 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:

  1. Prior myocardial infarction

  2. Prior stroke (ischemic or haemorrhagic stroke)

  3. Symptomatic peripheral arterial disease (PAD) defined as at least one of the following:

     1. Intermittent claudication with an ankle-brachial index (ABI) less than (<) 0.85 at rest
     2. 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
     3. Prior revascularization procedure of a lower extremity peripheral artery
     4. 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:

  1. Lifestyle intervention alone
  2. 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
  3. Basal insulin alone or in combination with up to two marketed OADs, all according to local label

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7,000 participants in 2 patient groups, including a placebo group

CagriSema 2.4 mg/2.4 mg

Experimental group

Description:

Participants will receive 2.4 milligrams (mg) cagrilintide and 2.4 mg semaglutide subcutaneously (s.c.) once-weekly after a dose escalation period of 16 weeks during the maintenance period of 219 weeks.

Treatment:

Drug: Cagrilintide

Drug: Semaglutide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide s.c. once weekly for 235 weeks.

Treatment:

Drug: Placebo