What this trial means for you
This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Cagrilintide, Semaglutide, Placebo for cardiovascular disease.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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
Study sites by state
Alabama
- Univ of Alabama Birmingham — Birmingham
- Chambliss Clinical Trials LLC — Montgomery
Arizona
- Honor Health — Scottsdale
California
- National Heart Institute Cal — Beverly Hills
- Valley Clinical Trials — Covina
- Scripps Wht Diab Inst La Jolla — La Jolla
- First Valley Medical Group — Lancaster
- Clinical Trials Research_Sacramento — Lincoln
- Torrance Clin Res Inst, Inc. — Lomita
- Pacific Clinical Studies — Los Alamitos
- Monterey Endocrine & Diabetes Institute, Inc — Monterey
- Valley Clinical Trials, Inc. — Northridge
- Desert Oasis Hlthcr Med Group — Palm Springs
- Western University of Health Sciences — Pomona
- Linda Vista Health Care Ctr — San Diego
- N America Res Inst - San Dimas — San Dimas
- Encompass Clinical Research_Spring Valley — Spring Valley
- Lundquist Inst.-Biom Inno-UCLA — Torrance
Connecticut
- Bridgeport Hospital — Bridgeport
Florida
- Innovative Research of W FL — Clearwater
- Florida Premier Cardiology — Delray Beach
- Fleming Island Center for Clinical Research — Fleming Island
- Life Spring Research Foundation LLC — Miami
- Oceane 7 Medical & Research Center, Inc. — Miami
- Reyes Clinical Research, Inc — Miami
- San Marcus Res Clin Miami Lakes — Miami Lakes
- Floridian Clinical Research, LLC — Miami Lakes
- Adult Medicine of Lake County, Inc. — Mt. Dora
- Suncoast Clinical Research, Inc. — New Port Richey
- Center for Diab,Obes & Metab — Pembroke Pines
- Hanson Clinical Research Center — Port Charlotte
- Northeast Research Institute — Saint Augustine
- Cardio Partners Clin Res Inst — Wellington
Georgia
- Endo Res Solutions Inc — Roswell
- Atlanta Heart Specialists, LLC — Tucker
Idaho
- Rocky Mountain Diab&Osteo Ctr — Idaho Falls
Illinois
- Northwest Heart Clinical Research, LLC — Arlington Heights
- Macoupin Research Group — Gillespie
- Clinical Invest Special_Gurnee — Gurnee
- Endeavor Health — Skokie
Indiana
- American Hlth Ntwk of IN LLC — Franklin
Iowa
- West Broadway Clinic — Council Bluffs
- Iowa Diab & Endo Res Center — West Des Moines
Kansas
- Midwest Heart & Vasc Spec — Overland Park
Kentucky
- The Research Group of Lexington LLC — Lexington
- L-MARC Research Center — Louisville
Louisiana
- Louisiana Heart Center — Covington
- Louisiana Heart Center — Hammond
- Tulane University Health Sciences Center — New Orleans
- Clinical Trials Of America — West Monroe
Maryland
- Ascension Saint Agnes Heart Ca — Baltimore
Michigan
- Elite Research Center — Flint
- Arcturus HC PLC Troy Med Res — Troy
Mississippi
- Memorial Hospital at Gulfport — Diamondhead
Missouri
- StudyMetrix Research LLC — City of Saint Peters
- Clinical Research Consultants, LLC — Kansas City
- Clinvest Research — Springfield
- Amicis Centers of Clinical Research — St Louis
- St Louis Heart & Vascular, P.C. — St Louis
Nebraska
- VA Neb West Iowa Hlth System — Omaha
- Methodist Physicians Clin — Omaha
- Univ of NE Med Center_Omaha — Omaha
New Hampshire
- Southern New Hampshire Diabetes and Endocrinology — Nashua
New Mexico
- Renal Medicine Associates — Albuquerque
New York
- Albany Medical College — Albany
- Mid Hudson Med Res-New Windsor — New Windsor
- IMA Clinical Research- NY — New York
- Saratoga Clinical Research — Saratoga Springs
- Prime Global Research Inc. — The Bronx
- Southgate Medical Group, LLP — West Seneca
- Great Lakes Medical Research — Westfield
North Carolina
- UNC- Chapel Hill — Chapel Hill
- Duke University — Durham
- Carteret Medical Group — Morehead City
- Eastern Nephrology Associates, PLLC — New Bern
- Piedmont Healthcare/Research — Statesville
- Brookview Hills Research Associates, LLC — Winston-Salem
North Dakota
- Lillestol Research LLC — Fargo
Ohio
- Cleveland Clinic - Main Campus — Cleveland
- Providence Health Partners Ctr — Dayton
- Ohio- Advanced Medical Research — Maumee
Pennsylvania
- Heritage Valley Medical Group — Beaver
- Capital Area Research LLC — Newport
- Aria Endocrine Metabolic Assoc — Philadelphia
South Carolina
- Carolina Health Specialists — Myrtle Beach
Tennessee
- Univ Diab & Endo Consultants — Chattanooga
Texas
- PharmaTex Research — Amarillo
- Arlington Family Res. Ctr Inc — Arlington
- South Texas Clinical Research — Corpus Christi
- Baylor Scott & White Res Inst — Dallas
- Velocity Clinical Res-Dallas — Dallas
- Dallas Heart and Vascular — Duncanville
- Academy of Diabetes, T&E — El Paso
- Diabetes and Thyroid Ctr of FW — Fort Worth
- Forefront Med Res Inst PLLC — Harlingen
- PrimeCare Medical Group — Houston
- Synergy Groups Medical — Houston
- Southwest Houston Research Ltd — Houston
- Prem Internal Med Asso Houston — Katy
- Radiance Clinical Research — Lampasas
- DCOL Ctr for Clin Res — Longview
- Texas Inst, Kdny & Endo Disor — Lufkin
- Texas Institute of Cardiology PA — McKinney
- Texas Diabetes & Endocrinology_Round Rock — Round Rock
- Clinical Advancement Center — San Antonio
- San Antonio Prem Int Med — San Antonio
- Audie L. Murphy VA Hospital — San Antonio
- Bexar County Hospital District — San Antonio
- Northeast Clinical Research of San Antonio — San Antonio
- Simcare Medical Research, LLC — Sugar Land
- Crossroads Clinical Res- Texas — Victoria
- Hillcrest Family Health Center — Waco
- Valley Diab. & Endo Comp Ctr — Weslaco
Virginia
- York Clinical Research LLC — Norfolk
- Dominion Medical Associates — Richmond
- VA Medical Center_Salem — Salem
- Selma Medical Associates — Winchester
Washington
- Confluence Health Hospital — Wenatchee
Wisconsin
- Aspirus Research Institute — Wausau
View the official record on ClinicalTrials.gov →
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