GLP-1 Evidence

Not medical advice. A record of published research and our assessments of it. The limits

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

Status
Active not recruitingResults none
Why it is watched
non-weight indication: cardiovascular, cerebrovascular
Who it enrolls
age 55 Years to no upper limit; no BMI minimum stated; conditions: Cardiovascular Disease
Interventions
Cagrilintide; Semaglutide; Placebo
Conditions
Cardiovascular Disease
Phase and size
Phase 3 · 7101 participants
Dates
Start 2023-03-01
Primary completion 2027-09-01
Sponsor
Novo Nordisk A/S (Industry)
Last checked
Sep 13, 2026
01Endpoints

What the trial will measure

  • Time to first occurrence of 3-point major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal strokeFrom baseline (week 0) to end of study (up to 242 weeks or more)
02Eligibility

Who can take part

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% (47-86 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
03Change log

Registry changes

No changes recorded since the trial was added.