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NCT Number: NCT05669755

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CEMEDIC, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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% (47-86 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

  • 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

Treatment and study plan

Cagrilintide

Drug

Participants will receive cagrilintide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.

semaglutide

Drug

Participants will receive semaglutide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.

Placebo

Drug

Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously.

Primary outcomes

  1. 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 stroke

    Time frame: From baseline (week 0) to end of study (up to 242 weeks or more)

    Measured in days.

Secondary outcomes

  1. Time to first occurrence of a composite endpoint: Onset of persistent ≥40% reduction in eGFRcr (CKD-EPI), eGFRcr (CKD-EPI) <15 mL/min/1.73 m^2, Initiation of chronic kidney replacement therapy, Kidney death and CV death

    Time frame: From baseline (week 0) to end of study (up to 242 weeks or more)

    CKD-EPI is Chronic Kidney Disease Epidemiology Collaboration. Measured in days.

  2. Time to first occurrence of composite endpoint consisting of: Onset of persistent macro albuminuria, ≥40% reduction in eGFRcr (CKD-EPI), eGFRcr (CKD-EPI) <15 mL/min/1.73 m^2, Initiation of chronic kidney replacement therapy and kidney death

    Time frame: From baseline (week 0) to end of study (up to 242 weeks or more)

    CKD-EPI is Chronic Kidney Disease Epidemiology Collaboration. Measured in days.

  3. Time to first occurrence of an expanded 5-point MACE composite endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation and unstable angina requiring hospitalisation

    Time frame: From baseline (week 0) to end of study (up to 242 weeks or more)

    Measured in days.

  4. Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction and non-fatal stroke

    Time frame: From baseline (week 0) to end of study (up to 242 weeks or more)

    Measured in days.

  5. Time to first occurrence of myocardial infarction (fatal and non-fatal)

    Time frame: From baseline (week 0) to end of study (up to 242 weeks or more)

    Measured in days.

  6. Time to first occurrence of stroke (fatal and non-fatal)

    Time frame: From baseline (week 0) to end of study (up to 242 weeks or more)

    Measured in days.

  7. Change in eGFRcr (CKD-EPI)

    Time frame: From baseline (week 0) to 120 weeks

    Measured in milliliter per min per 1.73 square meter (mL/min/1.73m^2).

  8. Ratio to baseline in Urine albumin-to-creatinine ratio (UACR)

    Time frame: From baseline (week 0) to 120 weeks

    Measured in ratio.

  9. Relative change in body weight

    Time frame: From baseline (week 0) to 120 weeks

    Measured in percentage (%).

  10. Change in waist circumference

    Time frame: From baseline (week 0) to 120 weeks

    Measured in centimeters (cm).

  11. Change in waist-to-height ratio

    Time frame: From baseline (week 0) to 120 weeks

    Measured in ratio.

  12. Change in systolic blood pressure (SBP)

    Time frame: From baseline (week 0) to 120 weeks

    Measured in millimeters of mercury (mmHg).

  13. Change in diastolic blood pressure (DBP)

    Time frame: From baseline (week 0) to 120 weeks

    Measured in mmHg.

  14. Ratio to baseline in lipids: Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, triglycerides and free fatty acids

    Time frame: From baseline (week 0) to 120 weeks

    Measured in ratio.

  15. Change in glycated haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to 120 weeks

    Measured in percentage-points.

  16. Number of treatment emergent serious adverse events (TESAEs)

    Time frame: From baseline (week 0) to end of study (up to 242 weeks or more)

    Measured in count of events.

  17. Number of event adjudication committee (EAC)-confirmed malignant neoplasms

    Time frame: From baseline (week 0) to end of study (up to 242 weeks or more)

    Measured as count of events.

  18. Number of severe hypoglycaemic episodes (level 3) (only for participants with type 2 diabetes mellitus [T2D] at screening)

    Time frame: From baseline (week 0) to end of study (up to 242 weeks or more)

    Measured as count of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

The Cardiovascular Safety and Efficacy of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) Once-weekly in Participants With Established Cardiovascular Disease

Acronym: REDEFINE 3

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 3, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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