A Research Study to Investigate How Well the Medicine CagriSema Lowers High Blood Pressure in People Living With High Blood Pressure and Obesity (REDEFINE)
30. oktober 2026 oppdatert av: Novo Nordisk A/S
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) in Participants With Hypertension and Obesity
This study is testing whether CagriSema is safe and works well in adults with high blood pressure and excess body weight. Participants will receive CagriSema, semaglutide, cagrilintide, or placebo, and treatment will be assigned by chance. CagriSema and cagrilintide are investigational medicines, while semaglutide is already available by prescription.
Studieoversikt
Status
Status
Har ikke rekruttert ennå
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Studietype
Studietype
Intervensjonell
Registrering (Antatt)
Registrering
1408
Fase
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
Studiekontakt
- Navn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-post: clinicaltrials@novonordisk.com
Studiesteder
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Buenos Aires, Argentina, C1425AGC
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
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CABA, Argentina, C1060ABA
- CEDIC Centro de Investigación Clínica
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CABA, Argentina, C1120AAC
- Centro Médico Viamonte SRL
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Rosario, Argentina, S2000PBJ
- CAICI
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Santiago del Estero, Argentina, G4200
- Sanatorio Norte
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1128 AAF
- Mautalen Salud e investigación
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CABA, Buenos Aires, Argentina, C1440CFD
- CEMEDIC
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Capital Federal, Buenos Aires, Argentina, C1056ABI
- Centro de Investigaciones Metabólicas
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La Pampa Province
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Santa Rosa, La Pampa Province, Argentina, 6300
- Fundación CESIM
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Mendoza Province
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Godoy Cruz, Mendoza, Mendoza Province, Argentina, 5501
- Hospital Español de Mendoza
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New South Wales
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Castle Hill, New South Wales, Australia, 2154
- Castle Hill Medical Centre
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Darlinghurst, New South Wales, Australia, 2010
- Momentum Clinical Research Darlinghurst
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Maroubra, New South Wales, Australia, 2035
- Australian Clinical Research Network
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Sydney, New South Wales, Australia, 2148
- Roger Chih Yu Chen
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Queensland
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Douglas, Queensland, Australia, 4814
- Townsville University Hospital
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Victoria
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Torquay, Victoria, Australia, 3228
- Clinical Trials Institute
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Western Australia
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Bunbury, Western Australia, Australia, 6230
- Brecken Health Clinical Trials
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Perth, Western Australia, Australia, 6000
- Dobney Hypertension Centre
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Alken, Belgia, 3570
- Anima Research Center
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Bonheiden, Belgia, 2820
- Imelda
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Genk, Belgia, 3600
- Ziekenhuis Oost-Limburg
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Ghent, Belgia, 9000
- Universitair Ziekenhuis Gent
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Leuven, Belgia, 3000
- Uz Leuven
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Mons, Belgia, 7000
- CHU Helora - Hôpital de Mons - Site Constantinople
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasil, 30455-610
- Centro Universitário de Belo Horizonte (UNIBH)
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Paraná
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Curitiba, Paraná, Brasil, 80230-130
- PUCPR - Pontificia Universidade Catolica do Parana
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São Paulo
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Bragança Paulista, São Paulo, Brasil, 12916-542
- Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista
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Campinas, São Paulo, Brasil, 13092-133
- i9 Pesquisas Clínicas
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Campinas, São Paulo, Brasil, 13060-803
- PUCCAMP - Hospital e Maternidade Celso Pierro
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Campinas, São Paulo, Brasil, 13083-887
- Centro de Pesquisa Clínica da Faculdade de Ciências Médicas - Unicamp
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São Paulo, São Paulo, Brasil, 05403-000
- Instituto do Coração - HCFMUSP
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São Paulo, São Paulo, Brasil, 04038-032
- IBTED Tecnologia e Educação em Diabetes - EPP
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São Paulo, São Paulo, Brasil, 01228-000
- CPQuali Pesquisa Clínica Ltda
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Burgas, Bulgaria, 8000
- Medical center Medconsult Burgas OOD
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Panagyurishte, Bulgaria, 4500
- MHAT - Uni Hospital OOD, Clinic of Cardiology
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Pernik, Bulgaria, 2308
- MHAT Rahila Angelova AD, Research Center
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Plovdiv, Bulgaria, 4002
- Dr. Ilcho Ilchev - AIPSMC - Cardiology EOOD
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Shumen, Bulgaria, 9700
- MHAT Shumen AD
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Sliven, Bulgaria, 8800
- GPSMC - Inacor OOD
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Sofia, Bulgaria, 1202
- DCC Ascendent OOD
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Sofia, Bulgaria, 1231
- MC Dr. Atanasov EOOD
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Sofia, Bulgaria, 1510
- MC Hera EOOD - Sofia
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Sofia, Bulgaria, 1431
- UMHAT Aleksandrovska EAD, Clinic of Cardiology
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Sofia, Bulgaria, 1750
- MHAT Sveta Anna Sofia AD, Clinic of Cardiology
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Sofia, Bulgaria, 1527
- UMHAT Tsaritsa Yoanna - ISUL EAD, Cardiology
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Sofia, Bulgaria, 1612
- Nevrovita - Medical Center OOD
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Varna, Bulgaria, 9010
- UMHAT Sveta Marina EAD, Clinic of Internal Diseases
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Varna, Bulgaria, 9009
- SHATC - Cardiolife OOD - Varna
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Québec, Canada, G1V 4T3
- Diex Recherche Quebec
-
Québec, Canada, G1V 4G5
- IUCPQ - Universite Laval
-
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British Columbia
-
Vancouver, British Columbia, Canada, V6Z 2T1
- Spectrum Health Clinic
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Victoria, British Columbia, Canada, V8V 4A1
- Dr. M.B. Jones Inc
-
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New Brunswick
-
Moncton, New Brunswick, Canada, E1G 1A7
- G.A. Research Associates Ltd.
-
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Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Health Authority
-
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Ontario
-
Hamilton, Ontario, Canada, L8L 5G4
- Premier Clinical Trial Research Network (PCTRN)
-
Hamilton, Ontario, Canada, L8L 5G4
- Hamilton Medical Research Group
-
London, Ontario, Canada, N5W 6A2
- Milestone Research
-
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Quebec
-
Trois-Rivières, Quebec, Canada, G9A 4P3
- Diex Recherche Trois-Rivieres
-
-
-
-
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Herning, Danmark, 7400
- Regionshospitalet Gødstrup - Universitetsklinikken for Nyresygdomme og Blodtryksforhøjelse
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Holbæk, Danmark, 4300
- Holbæk Sygehus - Forskningsenheden, Medicinsk Afdeling, afs. 44-4
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Hvidovre, Danmark, 2650
- Hvidovre Hospital Endokrinologisk forsknings afsnit 159
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Viborg, Danmark, 8800
- Viborg Sygehus
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Region Syddanmark
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Esbjerg, Region Syddanmark, Danmark, 6700
- Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
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California
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Concord, California, Forente stater, 94520
- John Muir Physicians Network
-
Costa Mesa, California, Forente stater, 92627
- Aurora FDRC Inc.
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Fullerton, California, Forente stater, 92835
- Providence Medical Foundation
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Montclair, California, Forente stater, 91763
- Catalina Research Institute, LLC
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Palm Springs, California, Forente stater, 92262
- Desert Oasis Hlthcr Med Group
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San Dimas, California, Forente stater, 91773
- N America Res Inst - San Dimas
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Connecticut
-
Waterbury, Connecticut, Forente stater, 06708
- Chase Medical Research LLC
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Florida
-
Clearwater, Florida, Forente stater, 33765
- Clinical Res Of W Florida Inc
-
Ocala, Florida, Forente stater, 34470
- Renstar Medical Research
-
Orlando, Florida, Forente stater, 32825
- Florida Institute for Clinical research
-
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Georgia
-
Albany, Georgia, Forente stater, 31707
- Javara Inc. / Privia Medical Group Georgia LLC
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Conyers, Georgia, Forente stater, 30094
- Hope Clin Res & Wellness
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Roswell, Georgia, Forente stater, 30076
- Endocrine Research Solutions, Inc
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Savannah, Georgia, Forente stater, 31406
- Javara Inc. / Privia Medical Group Georgia LLC
-
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Illinois
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Chicago, Illinois, Forente stater, 60640
- Great Lakes Clinical Trials
-
Morton, Illinois, Forente stater, 61550
- Koch Research
-
Skokie, Illinois, Forente stater, 60077
- Evanston Premier Hlthcr Res
-
Skokie, Illinois, Forente stater, 60077
- Endeavor Health
-
Springfield, Illinois, Forente stater, 62702
- SIU Medicine
-
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Indiana
-
Indianapolis, Indiana, Forente stater, 46260
- Midwest Inst For Clin Res
-
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Iowa
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West Des Moines, Iowa, Forente stater, 50266
- Iowa Diabetes Research
-
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Kentucky
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Bowling Green, Kentucky, Forente stater, 42101
- Graves Gibert Clinic
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Louisville, Kentucky, Forente stater, 40213
- Monroe Biomedical Research, LLC
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Michigan
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Buckley, Michigan, Forente stater, 49620
- Northern Pines Hlth Ctr, PC
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Flint, Michigan, Forente stater, 48504
- Aa Mrc Llc
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Missouri
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City of Saint Peters, Missouri, Forente stater, 63303
- StudyMetrix Research LLC
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St Louis, Missouri, Forente stater, 63128
- Amicis Centers of Clinical Research
-
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New Hampshire
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Portsmouth, New Hampshire, Forente stater, 03801
- Seacoast Kidney & Htn Specialists
-
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New York
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West Seneca, New York, Forente stater, 14224
- Southgate Medical Group, LLP
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Westfield, New York, Forente stater, 14787
- Great Lakes Medical Research
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North Carolina
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Raleigh, North Carolina, Forente stater, 27609
- Medication Management, LLC
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Raleigh, North Carolina, Forente stater, 27609
- Accellacare_NC
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Statesville, North Carolina, Forente stater, 28625
- Piedmont Healthcare, Inc.
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Ohio
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Canton, Ohio, Forente stater, 44718
- Diab & Endo Assoc of Stark Co
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Wadsworth, Ohio, Forente stater, 44281-9236
- Family Practice Center of Wadsworth Inc.
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Oklahoma
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Norman, Oklahoma, Forente stater, 73072
- Lynn Institute of Norman
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Rhode Island
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Cumberland, Rhode Island, Forente stater, 02864
- Clinical Res Collaborative
-
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South Carolina
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North Charleston, South Carolina, Forente stater, 29405
- Coastal Carolina Res Ctr
-
Spartanburg, South Carolina, Forente stater, 29303
- Spartanburg Medical Research
-
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Tennessee
-
Bristol, Tennessee, Forente stater, 37620
- Holston Medical Group Pc
-
Kingsport, Tennessee, Forente stater, 37660
- Holston Medical Group
-
Nashville, Tennessee, Forente stater, 37203
- Clinical Research Associates
-
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Texas
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Amarillo, Texas, Forente stater, 79124
- Amarillo Med Spec LLP
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Austin, Texas, Forente stater, 78731
- Texas Diabetes & Endocrinology
-
Austin, Texas, Forente stater, 78749
- Texas Diabetes & Endocrinology, P.A._Austin
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Bellaire, Texas, Forente stater, 77401
- Juno Research, LLC
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Dallas, Texas, Forente stater, 75231
- North Texas Endocrine Center
-
Dallas, Texas, Forente stater, 75226
- Baylor Jack and Jane Hamilton
-
Dallas, Texas, Forente stater, 75230
- Velocity Clin Res, Dallas
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Houston, Texas, Forente stater, 77079
- The Endocrine Center
-
Houston, Texas, Forente stater, 77036
- Discovery MM Services Inc
-
Lampasas, Texas, Forente stater, 76550
- Radiance Clinical Research
-
Longview, Texas, Forente stater, 75605
- DCOL Ctr for Clin Res
-
San Antonio, Texas, Forente stater, 78212
- Clinical Advancement Center
-
San Antonio, Texas, Forente stater, 78233
- Northeast Clinical Research of San Antonio
-
Shavano Park, Texas, Forente stater, 78231
- Consano Clinical Research, LLC
-
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Washington
-
Renton, Washington, Forente stater, 98057
- Rainier Clin Res Ctr Inc
-
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Apulia
-
Bari, Apulia, Italia, 70124
- AUO Consorziale Policlinico Bari - UOC Medicina Interna Universitaria (Cesare Frugoni)
-
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Calabria
-
Catanzaro, Calabria, Italia, 88100
- AOU Renato Dulbecco - Unità Operativa Complessa Medicina Interna
-
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Emilia-Romagna
-
Ferrara, Emilia-Romagna, Italia, 44124
- Arcispedale Sant'Anna (Cona) - Medicina Interna Universitaria
-
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Lazio
-
Rome, Lazio, Italia, 00189
- Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Cardiologia
-
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Lombardy
-
Brescia, Lombardy, Italia, 25123
- Spedali Civili Brescia - U.O. Medicina Generale 2
-
Milan, Lombardy, Italia, 20162
- Grande Ospedale Metropolitano Niguarda - Dipartimento di Cardiologia Clinica
-
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Molise
-
Pozzilli (IS), Molise, Italia, 86077
- NeuroMed S.p.A. - Dipartimento di Angio-Cardio-Neurologia
-
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RM
-
Rome, RM, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCS
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Sicily
-
Palermo, Sicily, Italia, 90127
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
-
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The Marches
-
Ancorna, The Marches, Italia, 60127
- INRCA Ancona - UOC Clinica Medica e Geriatrica
-
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Tuscany
-
Siena, Tuscany, Italia, 53100
- Azienda Ospedaliero Universitaria Senese - Endocrinologia
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Veneto
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Padova, Veneto, Italia, 35128
- Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica
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Arakawa-ku, Tokyo, Japan, 116-0012
- Kumanomae Nishimura Naika Clinic_Internal Medicine
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Okayama, Japan, 700-8558
- Okayama University Hospital_Neph. and Diabetes, Metabolism
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Sendai-shi, Miyagi, Japan, 983-0039
- Shinden Higashi Clinic_Internal medicine
-
Tokyo, Japan, 103-0027
- Tokyo-Eki Center-building Clinic_Internal Medicine
-
Tokyo, Japan, 104-0031
- Fukuwa Clinic_Internal Medicine
-
Tokyo, Japan, 160-0004
- Clinical Research Hospital Tokyo_Internal medicine
-
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Kanagawa
-
Yamato-shi, Kanagawa, Japan, 242-0004
- Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
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Deventer, Nederland, 7416 SE
- Deventer Ziekenhuis - Interne geneeskunde
-
Dordrecht, Nederland, 3318 AT
- Albert Schweitzer Zkh, Dordwijk - Nefrologie
-
Eindhoven, Nederland, 5623 EJ
- Catharina Zkh Eindhoven - Interne geneeskunde
-
Haarlem, Nederland, 2035 RC
- Spaarne Gasthuis Haarlem - Interne
-
Heerlen, Nederland, 6419 PC
- Zuyderland ziekenhuis - Interne
-
Hoogeveen, Nederland, 7909 AA
- Bethesda Diabetes Research Center
-
Nijmegen, Nederland, 6525 GA
- RadboudUMC - Vasculaire geneeskunde
-
Utrecht, Nederland, 3584 CX
- UMC Utrecht - Vasculaire geneeskunde
-
-
-
-
-
Elblag, Polen, 82-300
- Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
-
Gdansk, Polen, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Gdansk, Polen, 80-462
- Copernicus Podmiot Leczniczy Sp. z o.o.
-
Krakow, Polen, 30-721
- Linden sp. z o.o. sp. k.
-
Krakow, Polen, 31-322
- Gyncentrum Sp. z o. o.
-
Lodz, Polen, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
-
Rzeszów, Polen, 35-205
- EMED Centrum Usług Medycznych Ewa Smialek
-
Siedlce, Polen, 08-110
- Lukmed 2 Sp. z o.o.
-
Starachowice, Polen, 27-200
- Star Badania Kliniczne Sp. z o.o
-
Warsaw, Polen, 04-628
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
-
Świnoujście, Polen, 72-600
- Balticmed Świnoujście Sp. z o. o.
-
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Masovian Voivodeship
-
Grodzisk Mazowiecki, Masovian Voivodeship, Polen, 05-825
- Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II
-
Ostrów Mazowiecka, Masovian Voivodeship, Polen, 07-300
- Kresmed Sp. z o. o.
-
Warsaw, Masovian Voivodeship, Polen, 04-635
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
-
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Pomeranian Voivodeship
-
Gdynia, Pomeranian Voivodeship, Polen, 81-157
- Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
-
-
-
-
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Ponce, Puerto Rico, 00716
- Ponce Med School Found Inc
-
-
-
-
-
Badajoz, Spania, 06080
- Hospital Universitario de Badajoz
-
Barcelona, Spania, 08022
- Centro Médico Quirón-Teknon
-
Barcelona, Spania, 08036
- Clinic Barcelona_Endocrinología
-
León, Spania, 24008
- H. de León_Endocrinología
-
Madrid, Spania, 28016
- Hospital Universitario Sanitas Virgen del Mar
-
Madrid, Spania, 28009
- H.G.Marañón_Endocrino-Obesidad
-
Santander, Spania, 39008
- H. Univ. Marqués de Valdecilla_Endocrinología
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Santiago de Compostela, Spania, 15702
- Clínica Gaias Santiago
-
-
-
-
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Bristol, Storbritannia, BS37 4AX
- West Walk Surgery
-
Cambridge, Storbritannia, CB2 0QQ
- Addenbrooke's Hospital_Cambridge
-
Chippenham, Storbritannia, SN14 6GT
- Hathaway Medical Centre
-
Harrow, Storbritannia, HA3 7LT
- Belmont Health Centre
-
Hounslow, Storbritannia, TW4 7NJ
- HMC Health - Heston - The Meadows Centre for Health
-
London, Storbritannia, EC1M 6BQ
- William Harvey Research Institute
-
London, Storbritannia, SW1P 2PF
- Healthcare Central London - South Westminster Centre for Health
-
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Cambridgeshire
-
Wisbech, Cambridgeshire, Storbritannia, PE13 3UZ
- Trinity Surgery
-
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Cornwall
-
Newquay, Cornwall, Storbritannia, TR7 1RU
- Newquay Health Centre
-
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Hertfordshire
-
Bushey, Hertfordshire, Storbritannia, WD23 2NN
- Attenborough Surgery
-
-
-
-
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Busan, Sør -Korea, 49201
- Dong-A University Hospital_Family Medicine
-
Daegu, Sør -Korea, 41944
- Kyungpook National University Hospital_Family Medicine
-
Daegu, Sør -Korea, 42601
- Keimyung University Dongsan Hospital_Endocrinology
-
Daejeon, Sør -Korea, 35365
- Konyang University Hospital_Family Medicine
-
Seoul, Sør -Korea, 03722
- Severance Hospital, Yonsei University Health System_Family Medicine
-
Seoul, Sør -Korea, 04763
- Hanyang University Seoul Hospital_Family Medicine
-
-
Gyeonggi-do
-
Anyang-si, Gyeonggi-do, Sør -Korea, 14068
- Hallym University Sacred Heart Hospital_Family Medicine
-
Bucheon-si, Gyeonggi-do, Sør -Korea, 14647
- The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology
-
Seongnam-si, Gyeonggi-do, Sør -Korea, 13620
- Seoul National University Bundang Hospital_Family Medicine
-
-
Gyeongsangnam-do
-
Yangsan, Gyeongsangnam-do, Sør -Korea, 50612
- Pusan National University Yangsan Hospital_Family Medicine
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-
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Gauteng
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Johannesburg, Gauteng, Sør-Afrika, 2013
- Wits Bara Clinical Trial Site
-
Johannesburg, Gauteng, Sør-Afrika, 1818
- Soweto Clinical Trial Centre
-
Midrand, Gauteng, Sør-Afrika, 1685
- Dr A Jacovides and Partners Inc
-
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KwaZulu-Natal
-
Durban, KwaZulu-Natal, Sør-Afrika, 4091
- Dr Vawda's site
-
eMkhomazi, KwaZulu-Natal, Sør-Afrika, 4170
- Dr T Padayachee
-
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Lenasia
-
Gauteng, Lenasia, Sør-Afrika, 1827
- Dr Moosa's Rooms
-
-
-
-
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Berlin, Tyskland, 13405
- KARDIA - Dr. Hashemi
-
Duisburg, Tyskland, 47269
- MVZ Hausärzte Großenbaum GmbH Duisburg
-
Elsterwerda, Tyskland, 04910
- Zentrum für klinische Studien Südbrandenburg GmbH
-
Frankfurt, Tyskland, 60590
- Uniklinik FFM - Nephrologie
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Hamburg, Tyskland, 22607
- Wendisch - Dahl Hamburg - DZHW
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Münster, Tyskland, 48145
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
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Oldenburg in Holstein, Tyskland, 23758
- RED-Institut für medizinische Forschung und Fortbildung GmbH
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-
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-
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Budapest, Ungarn, H-1141
- Cardiogeneral Kft.
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Budapest, Ungarn, 1046
- Újpesti Egészségközpont
-
Budapest, Ungarn, H-1021
- Budapesti Szent Ferenc Kórház
-
Békéscsaba, Ungarn, 5600
- Trial Pharma Kft.
-
Békéscsaba, Ungarn, 5600
- Békés Vármegyei Központi Kórház
-
Szeged, Ungarn, 6724
- KomplexLabor Diagnosztika Kft.
-
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Bács-Kiskun county
-
Kalocsa, Bács-Kiskun county, Ungarn, 6300
- Stúdium Egészségház Kft.
-
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Hajdú-Bihar
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Debrecen, Hajdú-Bihar, Ungarn, 4032
- Debreceni Egyetem
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- Resting in-office SBP of 140-160 mmHg (both inclusive) at screening (V1-Optional/V1) and the Run-in visit. Systolic blood pressure will be calculated as the mean of the second and third consecutive readings of triplicated blood pressure readings collected at 2-minute intervals with the blood pressure monitor provided by the Sponsor.
- Body mass index greater than or equal to (>=) 30.0 kilograms per metre square (kg/m^2) at screening.
- Not receiving Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) or antihypertensive medication or on stable (i.e., same drug(s), dose and dosing frequency) SGLT2i or antihypertensive treatment >= 30 days prior to screening.
For participants with Type 2 Diabetes (T2D)
The following inclusion criteria apply at screening in addition to the inclusion criteria listed above:
- Diagnosed with T2D >= 90 days before screening.
- Glycated Haemoglobin (HbA1c) 6.5-10.0% (48-86 millimoles per mole (mmol/mol)) (both inclusive) as measured by the central laboratory at screening.
- Treatment with either lifestyle intervention only, or treatment with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors, glinides, SGLT2i or thiazolidinediones, as a single agent or in combination) according to local label.
- Treatment with antidiabetic medication should be stable (i.e., same drug(s), dose and dosing frequency) for at least 90 days before screening.
Exclusion Criteria:
- Known orthostatic hypotension or orthostatic hypotension at screening (V1-Optional/V1).
- Known secondary hypertension due to renovascular hypertension (renal artery stenosis), primary aldosteronism, Cushing's syndrome, pheochromocytoma, acromegaly, coarctation of the aorta, or any other identifiable cause of secondary hypertension.
- Currently under medical investigation for any cause of secondary hypertension.
- Hospitalisation within the last 90 days before screening for hypertension or hypertensive crisis.
- Atrial fibrillation at the Run-in visit or history of frequent intermittent or chronic atrial fibrillation.
- Moderate-to-severe anaemia with Hgb lesser than (<) 10.9 grams per decilitre (g/dL) as measured by the central lab at screening.
- A change in body weight greater than (>) 5% within 90 days before screening irrespective of medical records.
- Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.
- Use of any Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin agonists, within 90 days before screening.
For participants without T2D
- HbA1c greater than or equal to >= 6.5 % (48 mmol/mol) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Antall våpen
4
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
|
Eksperimentell: CagriSema
Participants will receive CagriSema subcutaneously once weekly. |
CagriSema will be administered subcutaneously. |
|
Aktiv komparator: Semaglutide
Participants will receive semaglutide subcutaneously once weekly. |
Semaglutide will be administered subcutaneously. |
|
Aktiv komparator: Cagrilintide
Participants will receive cagrilintide subcutaneously once weekly. |
Cagrilintide will be administered subcutaneously. |
|
Placebo komparator: Placebo
Participants will receive placebo subcutaneously once weekly. |
Placebo will be administered subcutaneously. |
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP)
Tidsramme: From baseline (week 0) to week 32
|
Measured in millimeters of mercury (mmHg). |
From baseline (week 0) to week 32
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
CagriSema versus Semaglutide and Cagrilintide : Change in in-office systolic blood pressure
Tidsramme: From baseline (week 0) to week 32
|
Measured in mmHg. |
From baseline (week 0) to week 32
|
|
Change in Home blood pressure monitoring (HBPM) -based systolic blood pressure
Tidsramme: From baseline (week 0) to week 32
|
Measured in mmHg. |
From baseline (week 0) to week 32
|
|
Number of participants who achieve a target goal of in-office systolic blood pressure lesser than or equal to (≤) 130 mmHg
Tidsramme: At Week 32
|
Measured as Count of participants. |
At Week 32
|
|
Number of participants who achieve American College of Cardiology and the American Heart Association (ACC/AHA) guidelines based blood pressure targets lesser than (<) 130/80 mmHg
Tidsramme: At Week 32
|
Measured as Count of participants. |
At Week 32
|
|
Change in body weight (%)
Tidsramme: From baseline (week 0) to week 32
|
Measured in percentage (%). |
From baseline (week 0) to week 32
|
|
Change in body weight (Kg)
Tidsramme: From baseline (week 0) to week 32
|
Measured in Kilograms (kg). |
From baseline (week 0) to week 32
|
|
Change in waist circumference
Tidsramme: From baseline (week 0) to week 32
|
Measured in centimetre (cm). |
From baseline (week 0) to week 32
|
|
Change in ACC/AHA 10-year atherosclerotic cardiovascular disease (ASCVD) risk score
Tidsramme: From baseline (week 0) to week 32
|
Measured in percentage of risk. ACC/AHA risk estimator calculates 10 year risk of ASCVD using a formula which includes age, sex, race, total cholesterol, high density lipoprotein (HDL) cholesterol, systolic blood pressure, blood pressure medication use, diabetes status, smoking status; minimum score 0, maximum score 100 where higher score indicates higher risk of 10-year risk of ASCVD. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: Total cholesterol
Tidsramme: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: HDL cholesterol
Tidsramme: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: Low Density Lipoprotein (LDL) cholesterol
Tidsramme: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: Very Low Density Lipoprotein (VLDL) cholesterol
Tidsramme: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: Non-HDL cholesterol
Tidsramme: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: Triglycerides
Tidsramme: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of high-sensitivity C-reactive protein (hsCRP)
Tidsramme: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Sponsor
Etterforskere
Etterforskere
- Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
Studiestart
11. november 2026
Primær fullføring (Antatt)
Primær fullføring
1. juni 2028
Studiet fullført (Antatt)
Studiet fullført
13. juli 2028
Datoer for studieregistrering
Først innsendt
Først innsendt
30. oktober 2026
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
30. oktober 2026
Først lagt ut (Faktiske)
Først lagt ut
5. november 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
5. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. oktober 2026
Sist bekreftet
Sist bekreftet
1. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
Andre studie-ID-numre
- NN9838-8768
- U1111-1338-1943 (Annen identifikator: World Health Organization (WHO))
- 2026-526360-21 (Annen identifikator: European Medical Agency (EMA))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .