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

STUDY OVERVIEW

This study by Novo Nordisk A/S will examine the effects of CagriSema on cardiovascular events, such as heart attacks and strokes, in individuals with cardiovascular disease. Participants will be randomly assigned to receive either CagriSema or a placebo, with an equal chance of receiving either treatment. The study medication will be administered via a weekly injection using a thin needle, typically in the stomach, thighs, or upper arms, over a period of up to 4.5 years.

STUDY GOALS

The goal of this study is to evaluate the effects of CagriSema on cardiovascular events, such as heart attacks and strokes, in individuals with cardiovascular disease over a period of up to 4.5 years.

LOCATION

El Paso, Texas: Texas Academy of Diabetes, Thyroid and Endocrine

INCLUSION CRITERIA

  • Male or female, aged 55 or older.

  • BMI of 25 kg/m² or higher.

  • Established cardiovascular disease (CVD) with evidence of:

    • Prior myocardial infarction or stroke.

    • Symptomatic peripheral arterial disease (PAD) with:

      • An ankle-brachial index (ABI) less than 0.85 at rest.

      • At least 50% stenosis in a lower extremity peripheral artery.

      • Prior revascularization procedure or amputation due to atherosclerosis.

  • For participants with type 2 diabetes (T2D):

    • Diagnosed with T2D for at least 180 days.

    • HbA1c levels between 6.5%-10%.

    • Treatment with lifestyle intervention, 1-3 oral antidiabetic drugs, or basal insulin with up to two oral antidiabetic drugs.

exclusion criteria

  • Recent myocardial infarction, stroke, or hospitalization for unstable angina or transient ischemic attack within 60 days.

  • Planned revascularization procedures.

  • Heart failure is classified as NYHA Class IV.

  • Use of GLP-1 receptor agonists within 90 days.

  • End-stage renal disease with eGFR < 15 mL/min/1.73 m².

  • Chronic or intermittent dialysis.

For more information, visit ClinicalTrials.gov.