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 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
1408
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-post: clinicaltrials@novonordisk.com
Studieorter
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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, Australien, 2154
- Castle Hill Medical Centre
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Darlinghurst, New South Wales, Australien, 2010
- Momentum Clinical Research Darlinghurst
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Maroubra, New South Wales, Australien, 2035
- Australian Clinical Research Network
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Sydney, New South Wales, Australien, 2148
- Roger Chih Yu Chen
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Queensland
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Douglas, Queensland, Australien, 4814
- Townsville University Hospital
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Victoria
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Torquay, Victoria, Australien, 3228
- Clinical Trials Institute
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Western Australia
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Bunbury, Western Australia, Australien, 6230
- Brecken Health Clinical Trials
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Perth, Western Australia, Australien, 6000
- Dobney Hypertension Centre
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Alken, Belgien, 3570
- Anima Research Center
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Bonheiden, Belgien, 2820
- Imelda
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Genk, Belgien, 3600
- Ziekenhuis Oost-Limburg
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Ghent, Belgien, 9000
- Universitair Ziekenhuis Gent
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Leuven, Belgien, 3000
- Uz Leuven
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Mons, Belgien, 7000
- CHU Helora - Hôpital de Mons - Site Constantinople
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 30455-610
- Centro Universitário de Belo Horizonte (UNIBH)
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Paraná
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Curitiba, Paraná, Brasilien, 80230-130
- PUCPR - Pontificia Universidade Catolica do Parana
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São Paulo
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Bragança Paulista, São Paulo, Brasilien, 12916-542
- Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista
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Campinas, São Paulo, Brasilien, 13092-133
- i9 Pesquisas Clínicas
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Campinas, São Paulo, Brasilien, 13060-803
- PUCCAMP - Hospital e Maternidade Celso Pierro
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Campinas, São Paulo, Brasilien, 13083-887
- Centro de Pesquisa Clínica da Faculdade de Ciências Médicas - Unicamp
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São Paulo, São Paulo, Brasilien, 05403-000
- Instituto do Coração - HCFMUSP
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São Paulo, São Paulo, Brasilien, 04038-032
- IBTED Tecnologia e Educação em Diabetes - EPP
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São Paulo, São Paulo, Brasilien, 01228-000
- CPQuali Pesquisa Clínica Ltda
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Burgas, Bulgarien, 8000
- Medical center Medconsult Burgas OOD
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Panagyurishte, Bulgarien, 4500
- MHAT - Uni Hospital OOD, Clinic of Cardiology
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Pernik, Bulgarien, 2308
- MHAT Rahila Angelova AD, Research Center
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Plovdiv, Bulgarien, 4002
- Dr. Ilcho Ilchev - AIPSMC - Cardiology EOOD
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Shumen, Bulgarien, 9700
- MHAT Shumen AD
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Sliven, Bulgarien, 8800
- GPSMC - Inacor OOD
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Sofia, Bulgarien, 1202
- DCC Ascendent OOD
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Sofia, Bulgarien, 1231
- MC Dr. Atanasov EOOD
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Sofia, Bulgarien, 1510
- MC Hera EOOD - Sofia
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Sofia, Bulgarien, 1431
- UMHAT Aleksandrovska EAD, Clinic of Cardiology
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Sofia, Bulgarien, 1750
- MHAT Sveta Anna Sofia AD, Clinic of Cardiology
-
Sofia, Bulgarien, 1527
- UMHAT Tsaritsa Yoanna - ISUL EAD, Cardiology
-
Sofia, Bulgarien, 1612
- Nevrovita - Medical Center OOD
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Varna, Bulgarien, 9010
- UMHAT Sveta Marina EAD, Clinic of Internal Diseases
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Varna, Bulgarien, 9009
- SHATC - Cardiolife OOD - Varna
-
-
-
-
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Herning, Danmark, 7400
- Regionshospitalet Gødstrup - Universitetsklinikken for Nyresygdomme og Blodtryksforhøjelse
-
Holbæk, Danmark, 4300
- Holbæk Sygehus - Forskningsenheden, Medicinsk Afdeling, afs. 44-4
-
Hvidovre, Danmark, 2650
- Hvidovre Hospital Endokrinologisk forsknings afsnit 159
-
Viborg, Danmark, 8800
- Viborg Sygehus
-
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Region Syddanmark
-
Esbjerg, Region Syddanmark, Danmark, 6700
- Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
-
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-
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California
-
Concord, California, Förenta staterna, 94520
- John Muir Physicians Network
-
Costa Mesa, California, Förenta staterna, 92627
- Aurora FDRC Inc.
-
Fullerton, California, Förenta staterna, 92835
- Providence Medical Foundation
-
Montclair, California, Förenta staterna, 91763
- Catalina Research Institute, LLC
-
Palm Springs, California, Förenta staterna, 92262
- Desert Oasis Hlthcr Med Group
-
San Dimas, California, Förenta staterna, 91773
- N America Res Inst - San Dimas
-
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Connecticut
-
Waterbury, Connecticut, Förenta staterna, 06708
- Chase Medical Research LLC
-
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Florida
-
Clearwater, Florida, Förenta staterna, 33765
- Clinical Res Of W Florida Inc
-
Ocala, Florida, Förenta staterna, 34470
- Renstar Medical Research
-
Orlando, Florida, Förenta staterna, 32825
- Florida Institute for Clinical research
-
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Georgia
-
Albany, Georgia, Förenta staterna, 31707
- Javara Inc. / Privia Medical Group Georgia LLC
-
Conyers, Georgia, Förenta staterna, 30094
- Hope Clin Res & Wellness
-
Roswell, Georgia, Förenta staterna, 30076
- Endocrine Research Solutions, Inc
-
Savannah, Georgia, Förenta staterna, 31406
- Javara Inc. / Privia Medical Group Georgia LLC
-
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Illinois
-
Chicago, Illinois, Förenta staterna, 60640
- Great Lakes Clinical Trials
-
Morton, Illinois, Förenta staterna, 61550
- Koch Research
-
Skokie, Illinois, Förenta staterna, 60077
- Evanston Premier Hlthcr Res
-
Skokie, Illinois, Förenta staterna, 60077
- Endeavor Health
-
Springfield, Illinois, Förenta staterna, 62702
- SIU Medicine
-
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Indiana
-
Indianapolis, Indiana, Förenta staterna, 46260
- Midwest Inst For Clin Res
-
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Iowa
-
West Des Moines, Iowa, Förenta staterna, 50266
- Iowa Diabetes Research
-
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Kentucky
-
Bowling Green, Kentucky, Förenta staterna, 42101
- Graves Gibert Clinic
-
Louisville, Kentucky, Förenta staterna, 40213
- Monroe Biomedical Research, LLC
-
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Michigan
-
Buckley, Michigan, Förenta staterna, 49620
- Northern Pines Hlth Ctr, PC
-
Flint, Michigan, Förenta staterna, 48504
- Aa Mrc Llc
-
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Missouri
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City of Saint Peters, Missouri, Förenta staterna, 63303
- StudyMetrix Research LLC
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St Louis, Missouri, Förenta staterna, 63128
- Amicis Centers of Clinical Research
-
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New Hampshire
-
Portsmouth, New Hampshire, Förenta staterna, 03801
- Seacoast Kidney & Htn Specialists
-
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New York
-
West Seneca, New York, Förenta staterna, 14224
- Southgate Medical Group, LLP
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Westfield, New York, Förenta staterna, 14787
- Great Lakes Medical Research
-
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North Carolina
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Raleigh, North Carolina, Förenta staterna, 27609
- Medication Management, LLC
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Raleigh, North Carolina, Förenta staterna, 27609
- Accellacare_NC
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Statesville, North Carolina, Förenta staterna, 28625
- Piedmont Healthcare, Inc.
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Ohio
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Canton, Ohio, Förenta staterna, 44718
- Diab & Endo Assoc of Stark Co
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Wadsworth, Ohio, Förenta staterna, 44281-9236
- Family Practice Center of Wadsworth Inc.
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Oklahoma
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Norman, Oklahoma, Förenta staterna, 73072
- Lynn Institute of Norman
-
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Rhode Island
-
Cumberland, Rhode Island, Förenta staterna, 02864
- Clinical Res Collaborative
-
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South Carolina
-
North Charleston, South Carolina, Förenta staterna, 29405
- Coastal Carolina Res Ctr
-
Spartanburg, South Carolina, Förenta staterna, 29303
- Spartanburg Medical Research
-
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Tennessee
-
Bristol, Tennessee, Förenta staterna, 37620
- Holston Medical Group Pc
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Kingsport, Tennessee, Förenta staterna, 37660
- Holston Medical Group
-
Nashville, Tennessee, Förenta staterna, 37203
- Clinical Research Associates
-
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Texas
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Amarillo, Texas, Förenta staterna, 79124
- Amarillo Med Spec LLP
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Austin, Texas, Förenta staterna, 78731
- Texas Diabetes & Endocrinology
-
Austin, Texas, Förenta staterna, 78749
- Texas Diabetes & Endocrinology, P.A._Austin
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Bellaire, Texas, Förenta staterna, 77401
- Juno Research, LLC
-
Dallas, Texas, Förenta staterna, 75231
- North Texas Endocrine Center
-
Dallas, Texas, Förenta staterna, 75226
- Baylor Jack and Jane Hamilton
-
Dallas, Texas, Förenta staterna, 75230
- Velocity Clin Res, Dallas
-
Houston, Texas, Förenta staterna, 77079
- The Endocrine Center
-
Houston, Texas, Förenta staterna, 77036
- Discovery MM Services Inc
-
Lampasas, Texas, Förenta staterna, 76550
- Radiance Clinical Research
-
Longview, Texas, Förenta staterna, 75605
- DCOL Ctr for Clin Res
-
San Antonio, Texas, Förenta staterna, 78212
- Clinical Advancement Center
-
San Antonio, Texas, Förenta staterna, 78233
- Northeast Clinical Research of San Antonio
-
Shavano Park, Texas, Förenta staterna, 78231
- Consano Clinical Research, LLC
-
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Washington
-
Renton, Washington, Förenta staterna, 98057
- Rainier Clin Res Ctr Inc
-
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Apulia
-
Bari, Apulia, Italien, 70124
- AUO Consorziale Policlinico Bari - UOC Medicina Interna Universitaria (Cesare Frugoni)
-
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Calabria
-
Catanzaro, Calabria, Italien, 88100
- AOU Renato Dulbecco - Unità Operativa Complessa Medicina Interna
-
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Emilia-Romagna
-
Ferrara, Emilia-Romagna, Italien, 44124
- Arcispedale Sant'Anna (Cona) - Medicina Interna Universitaria
-
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Lazio
-
Rome, Lazio, Italien, 00189
- Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Cardiologia
-
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Lombardy
-
Brescia, Lombardy, Italien, 25123
- Spedali Civili Brescia - U.O. Medicina Generale 2
-
Milan, Lombardy, Italien, 20162
- Grande Ospedale Metropolitano Niguarda - Dipartimento di Cardiologia Clinica
-
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Molise
-
Pozzilli (IS), Molise, Italien, 86077
- NeuroMed S.p.A. - Dipartimento di Angio-Cardio-Neurologia
-
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RM
-
Rome, RM, Italien, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCS
-
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Sicily
-
Palermo, Sicily, Italien, 90127
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
-
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The Marches
-
Ancorna, The Marches, Italien, 60127
- INRCA Ancona - UOC Clinica Medica e Geriatrica
-
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Tuscany
-
Siena, Tuscany, Italien, 53100
- Azienda Ospedaliero Universitaria Senese - Endocrinologia
-
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Veneto
-
Padova, Veneto, Italien, 35128
- Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica
-
-
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-
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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
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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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Québec, Kanada, G1V 4T3
- Diex Recherche Quebec
-
Québec, Kanada, G1V 4G5
- IUCPQ - Universite Laval
-
-
British Columbia
-
Vancouver, British Columbia, Kanada, V6Z 2T1
- Spectrum Health Clinic
-
Victoria, British Columbia, Kanada, V8V 4A1
- Dr. M.B. Jones Inc
-
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New Brunswick
-
Moncton, New Brunswick, Kanada, E1G 1A7
- G.A. Research Associates Ltd.
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3H 1V7
- Nova Scotia Health Authority
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8L 5G4
- Premier Clinical Trial Research Network (PCTRN)
-
Hamilton, Ontario, Kanada, L8L 5G4
- Hamilton Medical Research Group
-
London, Ontario, Kanada, N5W 6A2
- Milestone Research
-
-
Quebec
-
Trois-Rivières, Quebec, Kanada, G9A 4P3
- Diex Recherche Trois-Rivieres
-
-
-
-
-
Deventer, Nederländerna, 7416 SE
- Deventer Ziekenhuis - Interne geneeskunde
-
Dordrecht, Nederländerna, 3318 AT
- Albert Schweitzer Zkh, Dordwijk - Nefrologie
-
Eindhoven, Nederländerna, 5623 EJ
- Catharina Zkh Eindhoven - Interne geneeskunde
-
Haarlem, Nederländerna, 2035 RC
- Spaarne Gasthuis Haarlem - Interne
-
Heerlen, Nederländerna, 6419 PC
- Zuyderland ziekenhuis - Interne
-
Hoogeveen, Nederländerna, 7909 AA
- Bethesda Diabetes Research Center
-
Nijmegen, Nederländerna, 6525 GA
- RadboudUMC - Vasculaire geneeskunde
-
Utrecht, Nederländerna, 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.
-
-
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
-
-
Pomeranian Voivodeship
-
Gdynia, Pomeranian Voivodeship, Polen, 81-157
- Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
-
-
-
-
-
Ponce, Puerto Rico, 00716
- Ponce Med School Found Inc
-
-
-
-
-
Badajoz, Spanien, 06080
- Hospital Universitario de Badajoz
-
Barcelona, Spanien, 08022
- Centro Médico Quirón-Teknon
-
Barcelona, Spanien, 08036
- Clinic Barcelona_Endocrinología
-
León, Spanien, 24008
- H. de León_Endocrinología
-
Madrid, Spanien, 28016
- Hospital Universitario Sanitas Virgen del Mar
-
Madrid, Spanien, 28009
- H.G.Marañón_Endocrino-Obesidad
-
Santander, Spanien, 39008
- H. Univ. Marqués de Valdecilla_Endocrinología
-
Santiago de Compostela, Spanien, 15702
- Clínica Gaias Santiago
-
-
-
-
-
Bristol, Storbritannien, BS37 4AX
- West Walk Surgery
-
Cambridge, Storbritannien, CB2 0QQ
- Addenbrooke's Hospital_Cambridge
-
Chippenham, Storbritannien, SN14 6GT
- Hathaway Medical Centre
-
Harrow, Storbritannien, HA3 7LT
- Belmont Health Centre
-
Hounslow, Storbritannien, TW4 7NJ
- HMC Health - Heston - The Meadows Centre for Health
-
London, Storbritannien, EC1M 6BQ
- William Harvey Research Institute
-
London, Storbritannien, SW1P 2PF
- Healthcare Central London - South Westminster Centre for Health
-
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Cambridgeshire
-
Wisbech, Cambridgeshire, Storbritannien, PE13 3UZ
- Trinity Surgery
-
-
Cornwall
-
Newquay, Cornwall, Storbritannien, TR7 1RU
- Newquay Health Centre
-
-
Hertfordshire
-
Bushey, Hertfordshire, Storbritannien, WD23 2NN
- Attenborough Surgery
-
-
-
-
Gauteng
-
Johannesburg, Gauteng, Sydafrika, 2013
- Wits Bara Clinical Trial Site
-
Johannesburg, Gauteng, Sydafrika, 1818
- Soweto Clinical Trial Centre
-
Midrand, Gauteng, Sydafrika, 1685
- Dr A Jacovides and Partners Inc
-
-
KwaZulu-Natal
-
Durban, KwaZulu-Natal, Sydafrika, 4091
- Dr Vawda's site
-
eMkhomazi, KwaZulu-Natal, Sydafrika, 4170
- Dr T Padayachee
-
-
Lenasia
-
Gauteng, Lenasia, Sydafrika, 1827
- Dr Moosa's Rooms
-
-
-
-
-
Busan, Sydkorea, 49201
- Dong-A University Hospital_Family Medicine
-
Daegu, Sydkorea, 41944
- Kyungpook National University Hospital_Family Medicine
-
Daegu, Sydkorea, 42601
- Keimyung University Dongsan Hospital_Endocrinology
-
Daejeon, Sydkorea, 35365
- Konyang University Hospital_Family Medicine
-
Seoul, Sydkorea, 03722
- Severance Hospital, Yonsei University Health System_Family Medicine
-
Seoul, Sydkorea, 04763
- Hanyang University Seoul Hospital_Family Medicine
-
-
Gyeonggi-do
-
Anyang-si, Gyeonggi-do, Sydkorea, 14068
- Hallym University Sacred Heart Hospital_Family Medicine
-
Bucheon-si, Gyeonggi-do, Sydkorea, 14647
- The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology
-
Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Seoul National University Bundang Hospital_Family Medicine
-
-
Gyeongsangnam-do
-
Yangsan, Gyeongsangnam-do, Sydkorea, 50612
- Pusan National University Yangsan Hospital_Family Medicine
-
-
-
-
-
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
-
Hamburg, Tyskland, 22607
- Wendisch - Dahl Hamburg - DZHW
-
Münster, Tyskland, 48145
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
-
Oldenburg in Holstein, Tyskland, 23758
- RED-Institut für medizinische Forschung und Fortbildung GmbH
-
-
-
-
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Budapest, Ungern, H-1141
- Cardiogeneral Kft.
-
Budapest, Ungern, 1046
- Újpesti Egészségközpont
-
Budapest, Ungern, H-1021
- Budapesti Szent Ferenc Kórház
-
Békéscsaba, Ungern, 5600
- Trial Pharma Kft.
-
Békéscsaba, Ungern, 5600
- Békés Vármegyei Központi Kórház
-
Szeged, Ungern, 6724
- KomplexLabor Diagnosztika Kft.
-
-
Bács-Kiskun county
-
Kalocsa, Bács-Kiskun county, Ungern, 6300
- Stúdium Egészségház Kft.
-
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Hajdú-Bihar
-
Debrecen, Hajdú-Bihar, Ungern, 4032
- Debreceni Egyetem
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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-jämförare: Placebo
Participants will receive placebo subcutaneously once weekly. |
Placebo will be administered subcutaneously. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP)
Tidsram: From baseline (week 0) to week 32
|
Measured in millimeters of mercury (mmHg). |
From baseline (week 0) to week 32
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
CagriSema versus Semaglutide and Cagrilintide : Change in in-office systolic blood pressure
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: At Week 32
|
Measured as Count of participants. |
At Week 32
|
|
Change in body weight (%)
Tidsram: From baseline (week 0) to week 32
|
Measured in percentage (%). |
From baseline (week 0) to week 32
|
|
Change in body weight (Kg)
Tidsram: From baseline (week 0) to week 32
|
Measured in Kilograms (kg). |
From baseline (week 0) to week 32
|
|
Change in waist circumference
Tidsram: 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
Tidsram: 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
Tidsram: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: HDL cholesterol
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: Triglycerides
Tidsram: 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)
Tidsram: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
11 november 2026
Primärt slutförande (Beräknad)
1 juni 2028
Avslutad studie (Beräknad)
13 juli 2028
Studieregistreringsdatum
Först inskickad
30 oktober 2026
Först inskickad som uppfyllde QC-kriterierna
30 oktober 2026
Första postat (Faktisk)
5 november 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 oktober 2026
Senast verifierad
1 oktober 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NN9838-8768
- U1111-1338-1943 (Annan identifierare: World Health Organization (WHO))
- 2026-526360-21 (Annan identifierare: European Medical Agency (EMA))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .