Clinical trial

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

Active, not recruiting · Phase 3 · 3 countries · Registry ID NCT05669755

Active, not recruitingPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age55 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionCardiovascular Disease

Full registry criteria

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

Treatments and study arms

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

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 strokeFrom baseline (week 0) to end of study (up to 242 weeks or more)

Measured in days.

Study locations

633 locations were listed when this page was built. The first 40 are shown.

CIPREC Pueyrredon🇦🇷 Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli🇦🇷 Buenos Aires, Argentina
CEDIC Centro de Investigación Clínica🇦🇷 CABA, Argentina
CEMEDIC🇦🇷 CABA, Buenos Aires, Argentina
CENUDIAB Centro Médico de Nutrición v Diabetes🇦🇷 CABA, Argentina
CIPREC Arenales🇦🇷 CABA, Argentina
Mautalen Salud e investigación🇦🇷 CABA, Buenos Aires, Argentina
Medical Center of Diabetes and Nutrition🇦🇷 CABA, Argentina
Centro de Investigaciones Metabólicas🇦🇷 Capital Federal, Buenos Aires, Argentina
Centro Médico Privado San Vicente Diabetes🇦🇷 Córdoba, Argentina
Instituto Médico DAMIC🇦🇷 Córdoba, Argentina
Hospital Italiano de la Plata🇦🇷 La Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar Del Plata🇦🇷 Mar del Plata, Buenos Aires, Argentina
Consultorio Integral de Atención al Diabético🇦🇷 Morón, Argentina
Instituto Medico Catamarca🇦🇷 Rosario, Santa Fe Province, Argentina
Instituto de Investigaciones Clinicas San Nicolás🇦🇷 San Nicolás, Argentina
Sanatorio Norte🇦🇷 Santiago del Estero, Argentina
Nightingale Research Adelaide🇦🇺 Adelaide, South Australia, Australia
Royal Adelaide Hospital - Cardiology Department🇦🇺 Adelaide, South Australia, Australia
Advara HeartCare Auchenflower🇦🇺 Auchenflower, Queensland, Australia
Gosford Renal Research🇦🇺 Gosford, New South Wales, Australia
Royal Hobart Hospital🇦🇺 Hobart, Tasmania, Australia
Advara HeartCare Joondalup🇦🇺 Joondalup, Western Australia, Australia
Paratus Clinical🇦🇺 Kanwal, New South Wales, Australia
Southern Neurology🇦🇺 Kogarah, New South Wales, Australia
Advara HeartCare Leabrook🇦🇺 Leabrook, South Australia, Australia
Liverpool Hospital🇦🇺 Liverpool, New South Wales, Australia
Macquarie University - Clinical Trials Unit🇦🇺 Macquarie Park, New South Wales, Australia
Logan Hospital🇦🇺 Meadowbrook, Queensland, Australia
Baker Heart and Diabetes Institute🇦🇺 Melbourne, Victoria, Australia
One Clinical Research🇦🇺 Nedlands, Western Australia, Australia
Clinitrials🇦🇺 Perth, Western Australia, Australia
Clinitrials🇦🇺 West Perth, Western Australia, Australia
Instituto de Pesquisa Clínica de Campinas🇧🇷 Campinas, São Paulo, Brazil
PUCCAMP - Hospital e Maternidade Celso Pierro🇧🇷 Campinas, São Paulo, Brazil
i9 Pesquisas Clínicas🇧🇷 Campinas, São Paulo, Brazil
Núcleo de Pesquisa Clínica S/S🇧🇷 Curitiba, Paraná, Brazil
Centro de Pesquisa em Diabetes Doenças Endócrino-Metabólicas🇧🇷 Fortaleza, Ceará, Brazil
CPHosp Manaus Medicina, Ensino e Pesquisa LTDA🇧🇷 Manaus, Amazonas, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil