> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/redefine-3-a-research-study-to-see-the-effects-of-cagrisema-4205bb23-fcd9-4d2e-89ca-fc3075619f5b > Record changed: 2026-10-13 # REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels NCT05669755 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) Participants 7,101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) Lead sponsor Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) Start date 2023-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) Number of sites 633 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Acronym** REDEFINE 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Short title** REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) ## Dates **Completion date** 2027-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **First posted** 2023-01-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Registry last updated** 2026-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Primary completion date** 2027-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Start date** 2023-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) ## Size and sites **Actual participants** 7,101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Participants** 7,101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Number of sites** 633 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Lead sponsor** Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) ## Identifiers **Registry ID** NCT05669755 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **ClinicalTrials.gov ID** NCT05669755 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) ## Outcomes ### 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 Timeframe: 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 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 55 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) ## References ### Other registry identifiers (3) - jRCT2031220672 - 2021-005855-35 - U1111-1270-0943 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669755) ## Related records ### Drugs (2) - [Cagrilintide](https://trialight.com/data/asset/cagrilintide-83b81776-3caf-4dea-a1a9-64bd998ac431.md) - [Semaglutide](https://trialight.com/data/asset/semaglutide-0f0980aa-d386-4209-8f14-80da83c40d80.md) ### Lead sponsors (1) - [Novo Nordisk A/S](https://trialight.com/data/company/novo-nordisk-a-s-35a80f1a-9ef6-4057-99c1-6ab497939195.md) ### Conditions (1) - [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) Primary condition ### Targets (1) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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