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Clinical Trials in the UK / NCT05669755
Active, not recruiting Phase 3

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

NCT05669755 · tracked via the Priya Life Science UK tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2023-03-01
Last updated
2026-08-31

Condition(s) studied

Cardiovascular Disease

Investigational drug(s) / intervention(s)

CagrilintideSemaglutidePlacebo

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

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

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

Study 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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
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

Primary outcome measure(s)

Trial sites (633)

FacilityCityRegionStatus
Univ of Alabama Birmingham Birmingham Alabama
Chambliss Clinical Trials LLC Montgomery Alabama
Honor Health Scottsdale Arizona
National Heart Institute Cal Beverly Hills California
Valley Clinical Trials Covina California
Scripps Wht Diab Inst La Jolla La Jolla California
First Valley Medical Group Lancaster California
Clinical Trials Research_Sacramento Lincoln California
Torrance Clin Res Inst, Inc. Lomita California
Pacific Clinical Studies Los Alamitos California
Monterey Endocrine & Diabetes Institute, Inc Monterey California
Valley Clinical Trials, Inc. Northridge California
Desert Oasis Hlthcr Med Group Palm Springs California
Western University of Health Sciences Pomona California
Linda Vista Health Care Ctr San Diego California
N America Res Inst - San Dimas San Dimas California
Encompass Clinical Research_Spring Valley Spring Valley California
Lundquist Inst.-Biom Inno-UCLA Torrance California
Bridgeport Hospital Bridgeport Connecticut
Innovative Research of W FL Clearwater Florida
Florida Premier Cardiology Delray Beach Florida
Fleming Island Center for Clinical Research Fleming Island Florida
Life Spring Research Foundation LLC Miami Florida
Oceane 7 Medical & Research Center, Inc. Miami Florida
Reyes Clinical Research, Inc Miami Florida
San Marcus Res Clin Miami Lakes Miami Lakes Florida
Floridian Clinical Research, LLC Miami Lakes Florida
Adult Medicine of Lake County, Inc Mt. Dora Florida
Suncoast Clinical Research, Inc. New Port Richey Florida
Center for Diab,Obes & Metab Pembroke Pines Florida
Hanson Clinical Research Center Port Charlotte Florida
Northeast Research Institute Saint Augustine Florida
Cardio Partners Clin Res Inst Wellington Florida
Endo Res Solutions Inc Roswell Georgia
Atlanta Heart Specialists, LLC Tucker Georgia
Rocky Mountain Diab&Osteo Ctr Idaho Falls Idaho
Northwest Heart Clinical Research, LLC Arlington Heights Illinois
Macoupin Research Group Gillespie Illinois
Clinical Invest Special_Gurnee Gurnee Illinois
Endeavor Health Skokie Illinois

+ 593 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05669755 on ClinicalTrials.gov ↗ ← All trials in the UK