Language: BG BG
← Back to results
Active (not recruiting) Phase 3 NCT05669755

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

Phase 3 – large-scale trial before approval
Conditions: Cardiovascular Disease

Sponsor: Novo Nordisk A/S

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 24
Argentina (1)
Mautalen Salud e investigación
CABA , Buenos Aires
Australia (1)
Gosford Renal Research
Gosford , New South Wales
Brazil (1)
CPHosp Manaus Medicina, Ensino e Pesquisa LTDA
Manaus , Amazonas
Bulgaria (1)
Medical centre Asclepius OOD
Dupnitsa , Kyustendil
Canada (1)
Centricity Research Calgary Endocrinology
Calgary , Alberta
Colombia (1)
Servicios de Salud Ips Suramericana S.A.S.
Medellín , Antioquia
Denmark (1)
Herlev Hospital - Afdeling for Hjertesygdomme, Forskning 1
Herlev , Capital Region
France (1)
Centre Hospitalier d'Annonay
Annonay
India (1)
Endolife Specialty Hospitals
Guntur , Andhra Pradesh
Ireland (1)
CRF - Galway
Galway , Connaght
Italy (1)
Università degli studi G. D'Annunzio Chieti Pescara - CAST
Chieti , Abruzzo
Japan (1)
Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima , Fukushima, Japan
Malaysia (1)
University Malaya Medical Centre
Lembah Pantai , Kuala Lumpur
Mexico (1)
Centro de Investigacion Clinica Endocrinologica de Jalisco
Guadalajara , Jalisco
Netherlands (1)
Gelre Zkh Apeldoorn Cardiologie
Apeldoorn
Poland (1)
NSZOZ Unica CR
Dąbrówka , Greater Poland Voivodeship
Puerto Rico (1)
Isis Clinical Res. Ctr P.S.C.
Guaynabo
Serbia (1)
University Clinical Centre Nis
Niš , RS
South Africa (1)
Phoenix Pharma
Port Elizabeth , Eastern Cape
Spain (1)
Hospital Universitario de Fuenlabrada
Fuenlabrada , Madrid
Thailand (1)
Siriraj Hospital
Bangkok , Bangkok Noi
Turkey (1)
Baskent University Ankara Hospital
Ankara , Bahcelievler
United Kingdom (1)
Blackpool Victoria Hospital
Blackpool , Lancashire
United States (1)
Univ of Alabama Birmingham
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
55 Years
Healthy volunteers
No
Start date
01.03.2023
Completion date
13.10.2027
Registry ID
NCT05669755
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.