A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novo Nordisk A/S
Study ID
NCT07564414
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cagrisema — DRUG
    Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
  • Semaglutide — DRUG
    Semaglutide will be administered subcutaneously.

Study Details

This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks

Key Dates

Start date
May 21, 2026
Status verified
May 2026
Primary completion
Feb 23, 2028
Completion
Apr 19, 2028

Study Design

Enrollment
2,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cagrisema - dose level 1
    Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks.
  • Active Comparator: Cagrisema - dose level 2
    Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.
  • Active Comparator: Semaglutide
    Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.

Primary Outcome Measure

Relative change in body weight [ Time Frame: From randomisation (week 0) to end of treatment (week 72) ]

Central Contacts

Locations (99)

FacilityCityStateZIPSite coordinators
Uni of Alabama at BirminghamBirminghamAlabama35294-
Cahaba ResearchPelhamAlabama35124-
Elligo Health Research IncGilbertArizona85296-
Velocity Clinical Research-PhoenixPhoenixArizona85006-
Arkansas Clinical ResearchLittle RockArkansas72205-
Woodland Int. Research GroupLittle RockArkansas72211-
Headlands Research California, LLCEscondidoCalifornia92025-
Neighborhood HealthcareEscondidoCalifornia92025-
Diabetes & Endocrine Specialists - La MesaLa MesaCalifornia91942-
Clinical Trials Research_SacramentoLincolnCalifornia95648-
Loma Linda University Faculty Medical ClinicsLoma LindaCalifornia92354-
Pacific Clinical StudiesLos AlamitosCalifornia90720-
Valley Clinical TrialsNorthridgeCalifornia91325-
Desert Oasis HealthcarePalm SpringsCalifornia92262-
Linda Vista Health Care CtrSan DiegoCalifornia92111-
Velocity Clin Res - Van NuysVan NuysCalifornia91405-
Flourish Research - CAWalnut CreekCalifornia94598-
University of Colorado HospitalAuroraColorado80045-
TBMR & AlcanzaClearwaterFlorida33761-
Northeast Research InstituteFleming IslandFlorida32003-
Northeast Research InstituteJacksonvilleFlorida32204-
Westside Center For Clinical ResearchJacksonvilleFlorida32205-
Bioclinical Research AllianceMiamiFlorida33155-
New Horizon Research CenterMiamiFlorida33165-
South Broward Research LLCMiramarFlorida33027-
West Orange EndocrinologyOcoeeFlorida34761-
Oviedo Medical Research, LLCOviedoFlorida32765-
Clinical Trial Services CorpPembroke PinesFlorida33024-
Hope Clin Res & WellnessConyersGeorgia30094-
Center for Adv Res & EducationGainesvilleGeorgia30501-
Endocrine Research Solutions, IncRoswellGeorgia30076-
North Georgia Clinical ResearchWoodstockGeorgia30189-4255-
Solaris Clinical ResearchMeridianIdaho83646-
Cedar-Crosse Research CenterChicagoIllinois60607-
Macoupin Fam Practice Ctr, LLPGillespieIllinois62033-
Clinical Investigation Spec GurneeGurneeIllinois60031-
Endeavor HealthSkokieIllinois60077-
Evanston Premier Hlthcr ResSkokieIllinois60077-
Iowa Diabetes ResearchWest Des MoinesIowa50266-
Alliance for Multispecialty ResearchNewtonKansas67114-
Cotton O'Neil Diab & Endo CtrTopekaKansas66606-
The Research Group of Lexington LLCLexingtonKentucky40503-
Endo and Metabolic ConsultantsRockvilleMaryland20852-
Northern Pines Hlth Ctr, PCBuckleyMichigan49620-
International Diabetes CenterMinneapolisMinnesota55416-
AES Minneapolis DRSRichfieldMinnesota55423-
Belzoni Clinical ResearchBelzoniMississippi39038-
Clinical Research ProfessionalsChesterfieldMissouri63005-
Amicis Centers of Clinical ResearchSt LouisMissouri63128-
Southgate Medical Group, LLPWest SenecaNew York14224-
PharmQuest Life Sciences LLCGreensboroNorth Carolina27408-
Physician's East EndocrinologyGreenvilleNorth Carolina27834-
Carteret Medical GroupMorehead CityNorth Carolina28557-
Centricity Rsrch MHCity MultiMorehead CityNorth Carolina28557-
Piedmont Healthcare/ResearchStatesvilleNorth Carolina28625-
Accellacare WilmingtonWilmingtonNorth Carolina28401-
Lillestol Research LLCFargoNorth Dakota58104-
Plains Clinical Research Center, LLCFargoNorth Dakota58104-
Advanced Medical ResearchMaumeeOhio43537-
Alliance for Multispecialty ResearchNormanOklahoma73069-
Lynn Institute of NormanNormanOklahoma73072-
Heritage Valley Medical GroupBeaverPennsylvania15009-
Hatboro Med AssociatesHatboroPennsylvania19040-
Northeast Endocrine Metabolic AssociatesPhiladelphiaPennsylvania19114-
Clinical Res CollaborativeCumberlandRhode Island02864-
Velocity Clinical Research-GaffneyGaffneySouth Carolina29340-
Spartanburg Medical ResearchSpartanburgSouth Carolina29303-
Jackson ClinicJacksonTennessee38305-
Holston Medical GroupKingsportTennessee37660-
CNS HealthcareMemphisTennessee38119-
HealthStar Physicians, PCMorristownTennessee37813-
Clinical Research AssociatesNashvilleTennessee37203-
Amarillo Med Spec LLPAmarilloTexas79124-
Texas Diab & Endo, P.A.AustinTexas78731-
Velocity Clinical Research AustinAustinTexas78759-
North Texas Endocrine CenterDallasTexas75231-
Velocity Clin Res, DallasDallasTexas75230-
Cedar Health ResearchEulessTexas76040-
JCCT- Juno NW HoustonHoustonTexas77040-
The Endocrine CenterHoustonTexas77079-
Medical Colleagues-Texas LLPKatyTexas77450-
Sante Clinical ResearchKerrvilleTexas78028-
Radiance Clinical ResearchLampasasTexas76550-
Aeres Clinical ResearchLaredoTexas78041-
DCOL Ctr for Clin ResLongviewTexas75605-
RGV Endocrine CenterMcAllenTexas78503-
AES San AntonioSan AntonioTexas78229-
Northeast Clinical Research of San AntonioSan AntonioTexas78233-
Quality Research IncSan AntonioTexas78209-
Consano Clinical Research, LLCShavano ParkTexas78231-
Mt Olympus Medical Research, LLCSugar LandTexas77478-
J.Lewis Research IncSalt Lake CityUtah84109-
J.Lewis Research IncSalt Lake CityUtah84121-
Diabetes & Endo Tx SpecialistsSandy CityUtah84093-
J.Lewis Research IncSouth JordanUtah84095-
Health Res of Hampton RoadsNewport NewsVirginia23606-
Tidewater Physicians Multispecialty GroupNewport NewsVirginia23606-
National Clin Res Inc.RichmondVirginia23294-
Prevea HealthGreen BayWisconsin54303-

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