Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

Part of paid clinical trials in Daphne, Alabama.

Sponsor
Amgen
Study ID
NCT07037433
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Maridebart Cafraglutide — DRUG
    Maridebart cafraglutide will be administered SC.
  • Placebo — DRUG
    Placebo will be administered SC.

Study Details

The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.

Key Dates

Start date
Jul 25, 2025
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Sep 29, 2030

Study Design

Enrollment
12,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Maridebart Cafraglutide
    Participants will receive maridebart cafraglutide subcutaneously (SC).
  • Placebo Comparator: Placebo
    Participants will receive placebo SC.

Primary Outcome Measure

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, Myocardial Infarction (MI), or Ischemic Stroke (3-point Major Adverse Cardiac Events [3-P MACE]) [ Time Frame: Up to approximately 35 months ]

Central Contacts

Locations (139)

FacilityCityStateZIPSite coordinators
Alliance For Multispecialty Research - DaphneDaphneAlabama36526-
Eastern Shore Research InstituteFairhopeAlabama36532-
Heart Center Research LLCHuntsvilleAlabama35801-
Mobile Heart Specialists PCMobileAlabama36608-
Syed Research Consultants LLCSheffieldAlabama35660-
Medical Advancement Centers of ArizonaPhoenixArizona85044-
Synexus Clinical Research US, Inc.PhoenixArizona85020-
Valley Clinical Trials, LLC dba Flourish ResearchCovinaCalifornia91723-
Velocity Clinical Research- Huntington ParkHuntington ParkCalifornia90255-
Velocity Clinical Research- Los AngelesLa MesaCalifornia91942-
Orange County Research CenterLake ForestCalifornia92630-
Biopharma Informatic - The Cardiovascular CenterReddingCalifornia96001-
Acclaim Clinical ResearchSan DiegoCalifornia92120-
Encompass Clinical ResearchSpring ValleyCalifornia91978-
Diablo Clinical ResearchWalnut CreekCalifornia94598-
Focus Clinical ResearchWest HillsCalifornia91307-
Family Practice AssociatesWilmingtonDelaware19805-
Excel Medical Clinical TrialsBoca RatonFlorida33434-
Velocity Clinical Research - New Smyrna BeachEdgewaterFlorida32132-
Alliance for Multispecialty Research - Fort MyersFort MyersFlorida33912-
Elite Cardiac Research Center LLCHialeahFlorida33013-
Elite Clinical ResearchHialeahFlorida33018-
Indago Research and Health CenterHialeahFlorida33012-
Encore Medical Research LLCHollywoodFlorida33024-
Zenith Clinical ResearchHollywoodFlorida33021-
East Coast Institute for Research, LLCJacksonvilleFlorida32216-
Clinical Research of Central FloridaLakelandFlorida33805-
South Florida Clinical ResearchMargateFlorida33063-
Finlay Medical ResearchMiamiFlorida33126-
New Horizon Research CenterMiamiFlorida33165-
Suncoast Research Group LLCMiamiFlorida33135-
Panax Clinical ResearchMiami LakesFlorida33014-
San Marcus Research Clinic IncMiami LakesFlorida33014-
West Orange EndocrinologyOcoeeFlorida34761-
Cardiology Partners Clinical Research InstitutePalm Beach GardensFlorida33410-
Peace River Cardiovascular CenterPort CharlotteFlorida33952-
Progressive Medical ResearchPort OrangeFlorida32127-
Saint Johns Center for Clinical ResearchSaint AugustineFlorida32086-
Intercoastal Medical GroupSarasotaFlorida34239-
Winter Haven HospitalWinter HavenFlorida33881-
East Coast Institute for Research LLC at Canton GeorgiaCantonGeorgia30114-
The Jones Center Clinical ResearchMaconGeorgia31210-
Velocity Clinical Research - SavannahSavannahGeorgia31419-
Velocity Clinical Research - BoiseMeridianIdaho83642-
Endeavor Health-Northwest Community HealthcareArlington HeightsIllinois60005-
Eagle Clinical ResearchChicagoIllinois60621-
University of ChicagoChicagoIllinois60637-
Alliance For Multispecialty Research - Oak BrookOak BrookIllinois60523-
Prarie Education and ResearchSpringfieldIllinois62701-
Cardiovascular Research of Northwest Indiana LLCMunsterIndiana46321-
Velocity Clinical Research - ValparaisoValparaisoIndiana46383-
McFarland Clinic PCAmesIowa50010-
Midwest Cardiovascular Research FoundationDavenportIowa52801-
Cotton-ONeil Diabetes and Endocrinology CenterTopekaKansas66606-
Monroe Biomedical ResearchLouisvilleKentucky40213-
Cardiovascular Associates Research, LLCCovingtonLouisiana70433-
Tandem Clinical Research - MarreroMarreroLouisiana70072-
Ascension Saint Agnes Heart CareBaltimoreMaryland21229-
MD Medical ResearchOxon HillMaryland20745-
Velocity Clinical Research - RockvilleRockvilleMaryland20854-
Btc of New BedfordNew BedfordMassachusetts02740-
Fairview Health Services M Health Fairview St Johns HospitalMaplewoodMinnesota55109-
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407-
Jackson Heart ClinicJacksonMississippi39216-
Cardiology Associates of North MississippiTupeloMississippi38801-
StudyMetrix ResearchCity of Saint PetersMissouri63303-
Alliance for Multispecialty Research - Kansas CityKansas CityMissouri64114-
Kansas City Veterans Affairs Medical CenterKansas CityMissouri64128-
Saint Louis Heart and Vascular PCSt LouisMissouri63136-
Bryan HeartLincolnNebraska68506-
University of Nebraska Medical CenterOmahaNebraska68198-
Primary Clinical ResearchPapillionNebraska68046-
Excel Clinical ResearchLas VegasNevada89109-
Vector Clinical TrialsLas VegasNevada89128-
CardioMetabolic Collaborative ClinicSomersetNew Jersey08873-
Velocity Clinical Research - BinghamtonBinghamtonNew York13905-
Hudson Valley Cardiovascular Practice PCPoughkeepsieNew York12601-
Rochester Clinical ResearchRochesterNew York14609-
Saratoga Clinical Research, LLCSaratoga SpringsNew York12866-
Southgate Medical GroupWest SenecaNew York14224-
Novant Health Heart and Vascular InstituteCharlotteNorth Carolina28204-
Velocity Clinical Research - DurhamDurhamNorth Carolina27701-
Moses H Cone Memorial HospitalGreensboroNorth Carolina27401-
Monroe Biomedical ResearchMonroeNorth Carolina28112-
West Clinical ResearchMorehead CityNorth Carolina28557-
Burke Primary Care Family PracticeMorgantonNorth Carolina28655-
Accellacare of RaleighRaleighNorth Carolina27609-
Accellacare of Piedmont HealthcareStatesvilleNorth Carolina28625-
Brookview Hills Research Associates LlcWinston-SalemNorth Carolina27103-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Velocity Clinical Research - ClevelandBeachwoodOhio44122-
Aultman Hospital, Cardiovascular Consultants, IncCantonOhio44710-
Velocity Clinical Research - AuburnCincinnatiOhio45219-
Endocrinology Associates IncColumbusOhio43201-
Nexgen ResearchLimaOhio45801-
Alliance for Multispecialty Research - NormanNormanOklahoma73069-
Heritage Valley Multispecialty Group IncBeaverPennsylvania15009-
Capital Area Research LLCCamp HillPennsylvania17011-
Abington Medical SpecialistsHorshamPennsylvania19044-
Velocity Clinical Research - ProvidenceEast GreenwichRhode Island02818-
Accellacare CharlestonMt. PleasantSouth Carolina29464-
Monument Health Clinical ResearchRapid CitySouth Dakota57701-
Stern Cardiovascular Foundation IncGermantownTennessee38138-
Accellacare of KnoxvilleKnoxvilleTennessee37912-
Cardiovascular Research of Knoxville North Knoxville Medical CenterPowellTennessee37849-
Tennessee Center for Clinical TrialsTullahomaTennessee37388-
PharmaTex Research, LLCAmarilloTexas79106-
Austin HeartAustinTexas78705-
Velocity Clinical Research - AustinAustinTexas78759-
Cedar Health Research, LLCDallasTexas75251-
Soltero Cardiovascular Research CenterDallasTexas75226-
Thyroid Endocrinology and DiabetesDallasTexas75208-
University of Texas Southwestern Medical CenterDallasTexas75390-
Zenos Clinical ResearchDallasTexas75230-
Academy of Diabetes Thyroid and EndocrineEl PasoTexas79935-
David Turbay, MDEl PasoTexas79905-
Biopharma Informatic, LLCHoustonTexas77043-
Cardiovascular Specialists of WillowbrookHoustonTexas77070-
PlanIt Research, PLLCHoustonTexas77079-
Research Physicians Network, LLCHoustonTexas77089-
Vital Heart and VeinHumbleTexas77338-
Tcr Institute LlcKingwoodTexas77339-
Helium Research GroupLake JacksonTexas77566-
Epic Clinical ResearchLewisvilleTexas75057-
Biopharma Informatic-McAllenMcAllenTexas78503-
Southern Endocrinology Associates PAMesquiteTexas75149-
North Hills Medical ResearchNorth Richland HillsTexas76180-
Bandera Family Health CareSan AntonioTexas78249-
Consano Clinical Research - Shavano ParkShavano ParkTexas78231-
Sugar Lakes Family PracticeSugar LandTexas77479-
Wichita Falls Heart ClinicWichita FallsTexas76301-
Boeson ResearchProvoUtah84604-
Velocity Clinical Research - Salt Lake CityWest JordanUtah84088-
Inova Cardiology - FairfaxFairfaxVirginia22031-
Virginia HeartFalls ChurchVirginia22042-
VA Puget Sound Healthcare SystemSeattleWashington98108-
Velocity Clinical Research - SpokaneSpokaneWashington99218-
Vaught Neurological ServicesCrab OrchardWest Virginia25827-
Aspirus Cardiovascular AssociatesWausauWisconsin54401-

Find similar trials in Daphne, AL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Alliance For Multispecialty Research - Daphne· Daphne, ALEastern Shore Research Institute· Fairhope, ALHeart Center Research LLC· Huntsville, ALMobile Heart Specialists PC· Mobile, ALSyed Research Consultants LLC· Sheffield, ALMedical Advancement Centers of Arizona· Phoenix, AZ

Related Studies