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

NCT05669755
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Participants
7,101
clinicaltrials.gov
Lead sponsor
Novo Nordisk A/S
clinicaltrials.gov
Start date
2023-03-01
clinicaltrials.gov
Number of sites
633
clinicaltrials.gov

Summary
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.
clinicaltrials.gov
Acronym
REDEFINE 3
clinicaltrials.gov
Short title
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
clinicaltrials.gov
Official 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
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2027-10-13
clinicaltrials.gov
First posted
2023-01-03
clinicaltrials.gov
Registry last updated
2026-07-17
clinicaltrials.gov
Primary completion date
2027-09-01
clinicaltrials.gov
Start date
2023-03-01
clinicaltrials.gov

Actual participants
7,101
clinicaltrials.gov
Participants
7,101
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
3
clinicaltrials.gov
Number of sites
633
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Novo Nordisk A/S
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05669755
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05669755
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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

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

    Measured in days.

  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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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)

    Timeframe: 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)

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

    Measured in days.

  7. Change in eGFRcr (CKD-EPI)

    Timeframe: 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)

    Timeframe: From baseline (week 0) to 120 weeks

    Measured in ratio.

  9. Relative change in body weight

    Timeframe: From baseline (week 0) to 120 weeks

    Measured in percentage (%).

  10. Change in waist circumference

    Timeframe: From baseline (week 0) to 120 weeks

    Measured in centimeters (cm).

  11. Change in waist-to-height ratio

    Timeframe: From baseline (week 0) to 120 weeks

    Measured in ratio.

  12. Change in systolic blood pressure (SBP)

    Timeframe: From baseline (week 0) to 120 weeks

    Measured in millimeters of mercury (mmHg).

  13. Change in diastolic blood pressure (DBP)

    Timeframe: 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

    Timeframe: From baseline (week 0) to 120 weeks

    Measured in ratio.

  15. Change in glycated haemoglobin (HbA1c)

    Timeframe: From baseline (week 0) to 120 weeks

    Measured in percentage-points.

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

    Timeframe: 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

    Timeframe: 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)

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

    Measured as count of events.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
55 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Univ of Alabama BirminghamBirmingham, United States
  • Chambliss Clinical Trials LLCMontgomery, United States
  • Honor HealthScottsdale, United States
  • National Heart Institute CalBeverly Hills, United States
  • Valley Clinical TrialsCovina, United States
  • Scripps Wht Diab Inst La JollaLa Jolla, United States
  • First Valley Medical GroupLancaster, United States
  • Clinical Trials Research_SacramentoLincoln, United States
  • Torrance Clin Res Inst, Inc.Lomita, United States
  • Pacific Clinical StudiesLos Alamitos, United States
  • Monterey Endocrine & Diabetes Institute, IncMonterey, United States
  • Valley Clinical Trials, Inc.Northridge, United States
  • Desert Oasis Hlthcr Med GroupPalm Springs, United States
  • Western University of Health SciencesPomona, United States
  • Linda Vista Health Care CtrSan Diego, United States
  • N America Res Inst - San DimasSan Dimas, United States
  • Encompass Clinical Research_Spring ValleySpring Valley, United States
  • Lundquist Inst.-Biom Inno-UCLATorrance, United States
  • Bridgeport HospitalBridgeport, United States
  • Innovative Research of W FLClearwater, United States
  • Florida Premier CardiologyDelray Beach, United States
  • Fleming Island Center for Clinical ResearchFleming Island, United States
  • Life Spring Research Foundation LLCMiami, United States
  • Oceane 7 Medical & Research Center, Inc.Miami, United States
  • Reyes Clinical Research, IncMiami, United States

And 608 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • jRCT2031220672
  • 2021-005855-35
  • U1111-1270-0943
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)