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HomeTrials › NCT05669755

Cardiovascular · Phase 3 · Active, not recruiting

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

NCT05669755 · Sponsor: Novo Nordisk A/S

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.

Who can joinAll sexes, 55 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeCagrilintide, Semaglutide, Placebo
Study length~4.5 years overall
Planned participants7,101
TypeInterventional (you receive treatment)

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 →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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