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 ottobre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Stato
Non ancora reclutamento
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Stimato)
Iscrizione
1408
Fase
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: Novo Nordisk
- Numero di telefono: (+1) 866-867-7178
- Email: clinicaltrials@novonordisk.com
Luoghi di studio
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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, Belgio, 3570
- Anima Research Center
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Bonheiden, Belgio, 2820
- Imelda
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Genk, Belgio, 3600
- Ziekenhuis Oost-Limburg
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Ghent, Belgio, 9000
- Universitair Ziekenhuis Gent
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Leuven, Belgio, 3000
- Uz Leuven
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Mons, Belgio, 7000
- CHU Helora - Hôpital de Mons - Site Constantinople
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasile, 30455-610
- Centro Universitário de Belo Horizonte (UNIBH)
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Paraná
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Curitiba, Paraná, Brasile, 80230-130
- PUCPR - Pontificia Universidade Catolica do Parana
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São Paulo
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Bragança Paulista, São Paulo, Brasile, 12916-542
- Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista
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Campinas, São Paulo, Brasile, 13092-133
- i9 Pesquisas Clínicas
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Campinas, São Paulo, Brasile, 13060-803
- PUCCAMP - Hospital e Maternidade Celso Pierro
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Campinas, São Paulo, Brasile, 13083-887
- Centro de Pesquisa Clínica da Faculdade de Ciências Médicas - Unicamp
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São Paulo, São Paulo, Brasile, 05403-000
- Instituto do Coração - HCFMUSP
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São Paulo, São Paulo, Brasile, 04038-032
- IBTED Tecnologia e Educação em Diabetes - EPP
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São Paulo, São Paulo, Brasile, 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
-
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)
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Hamilton, Ontario, Canada, L8L 5G4
- Hamilton Medical Research Group
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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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Busan, Corea del Sud, 49201
- Dong-A University Hospital_Family Medicine
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Daegu, Corea del Sud, 41944
- Kyungpook National University Hospital_Family Medicine
-
Daegu, Corea del Sud, 42601
- Keimyung University Dongsan Hospital_Endocrinology
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Daejeon, Corea del Sud, 35365
- Konyang University Hospital_Family Medicine
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Seoul, Corea del Sud, 03722
- Severance Hospital, Yonsei University Health System_Family Medicine
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Seoul, Corea del Sud, 04763
- Hanyang University Seoul Hospital_Family Medicine
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Gyeonggi-do
-
Anyang-si, Gyeonggi-do, Corea del Sud, 14068
- Hallym University Sacred Heart Hospital_Family Medicine
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Bucheon-si, Gyeonggi-do, Corea del Sud, 14647
- The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology
-
Seongnam-si, Gyeonggi-do, Corea del Sud, 13620
- Seoul National University Bundang Hospital_Family Medicine
-
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Gyeongsangnam-do
-
Yangsan, Gyeongsangnam-do, Corea del Sud, 50612
- Pusan National University Yangsan Hospital_Family Medicine
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Herning, Danimarca, 7400
- Regionshospitalet Gødstrup - Universitetsklinikken for Nyresygdomme og Blodtryksforhøjelse
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Holbæk, Danimarca, 4300
- Holbæk Sygehus - Forskningsenheden, Medicinsk Afdeling, afs. 44-4
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Hvidovre, Danimarca, 2650
- Hvidovre Hospital Endokrinologisk forsknings afsnit 159
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Viborg, Danimarca, 8800
- Viborg Sygehus
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Region Syddanmark
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Esbjerg, Region Syddanmark, Danimarca, 6700
- Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
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Berlin, Germania, 13405
- KARDIA - Dr. Hashemi
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Duisburg, Germania, 47269
- MVZ Hausärzte Großenbaum GmbH Duisburg
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Elsterwerda, Germania, 04910
- Zentrum für klinische Studien Südbrandenburg GmbH
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Frankfurt, Germania, 60590
- Uniklinik FFM - Nephrologie
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Hamburg, Germania, 22607
- Wendisch - Dahl Hamburg - DZHW
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Münster, Germania, 48145
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
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Oldenburg in Holstein, Germania, 23758
- RED-Institut für medizinische Forschung und Fortbildung GmbH
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Arakawa-ku, Tokyo, Giappone, 116-0012
- Kumanomae Nishimura Naika Clinic_Internal Medicine
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Okayama, Giappone, 700-8558
- Okayama University Hospital_Neph. and Diabetes, Metabolism
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Sendai-shi, Miyagi, Giappone, 983-0039
- Shinden Higashi Clinic_Internal medicine
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Tokyo, Giappone, 103-0027
- Tokyo-Eki Center-building Clinic_Internal Medicine
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Tokyo, Giappone, 104-0031
- Fukuwa Clinic_Internal Medicine
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Tokyo, Giappone, 160-0004
- Clinical Research Hospital Tokyo_Internal medicine
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Kanagawa
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Yamato-shi, Kanagawa, Giappone, 242-0004
- Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
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Apulia
-
Bari, Apulia, Italia, 70124
- AUO Consorziale Policlinico Bari - UOC Medicina Interna Universitaria (Cesare Frugoni)
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Calabria
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Catanzaro, Calabria, Italia, 88100
- AOU Renato Dulbecco - Unità Operativa Complessa Medicina Interna
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Emilia-Romagna
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Ferrara, Emilia-Romagna, Italia, 44124
- Arcispedale Sant'Anna (Cona) - Medicina Interna Universitaria
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Lazio
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Rome, Lazio, Italia, 00189
- Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Cardiologia
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Lombardy
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Brescia, Lombardy, Italia, 25123
- Spedali Civili Brescia - U.O. Medicina Generale 2
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Milan, Lombardy, Italia, 20162
- Grande Ospedale Metropolitano Niguarda - Dipartimento di Cardiologia Clinica
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Molise
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Pozzilli (IS), Molise, Italia, 86077
- NeuroMed S.p.A. - Dipartimento di Angio-Cardio-Neurologia
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RM
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Rome, RM, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCS
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Sicily
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Palermo, Sicily, Italia, 90127
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
-
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The Marches
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Ancorna, The Marches, Italia, 60127
- INRCA Ancona - UOC Clinica Medica e Geriatrica
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Tuscany
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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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Deventer, Olanda, 7416 SE
- Deventer Ziekenhuis - Interne geneeskunde
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Dordrecht, Olanda, 3318 AT
- Albert Schweitzer Zkh, Dordwijk - Nefrologie
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Eindhoven, Olanda, 5623 EJ
- Catharina Zkh Eindhoven - Interne geneeskunde
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Haarlem, Olanda, 2035 RC
- Spaarne Gasthuis Haarlem - Interne
-
Heerlen, Olanda, 6419 PC
- Zuyderland ziekenhuis - Interne
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Hoogeveen, Olanda, 7909 AA
- Bethesda Diabetes Research Center
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Nijmegen, Olanda, 6525 GA
- RadboudUMC - Vasculaire geneeskunde
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Utrecht, Olanda, 3584 CX
- UMC Utrecht - Vasculaire geneeskunde
-
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Elblag, Polonia, 82-300
- Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
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Gdansk, Polonia, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Gdansk, Polonia, 80-462
- Copernicus Podmiot Leczniczy Sp. z o.o.
-
Krakow, Polonia, 30-721
- Linden sp. z o.o. sp. k.
-
Krakow, Polonia, 31-322
- Gyncentrum Sp. z o. o.
-
Lodz, Polonia, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
-
Rzeszów, Polonia, 35-205
- EMED Centrum Usług Medycznych Ewa Smialek
-
Siedlce, Polonia, 08-110
- Lukmed 2 Sp. z o.o.
-
Starachowice, Polonia, 27-200
- Star Badania Kliniczne Sp. z o.o
-
Warsaw, Polonia, 04-628
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
-
Świnoujście, Polonia, 72-600
- Balticmed Świnoujście Sp. z o. o.
-
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Masovian Voivodeship
-
Grodzisk Mazowiecki, Masovian Voivodeship, Polonia, 05-825
- Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II
-
Ostrów Mazowiecka, Masovian Voivodeship, Polonia, 07-300
- Kresmed Sp. z o. o.
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Warsaw, Masovian Voivodeship, Polonia, 04-635
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
-
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Pomeranian Voivodeship
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Gdynia, Pomeranian Voivodeship, Polonia, 81-157
- Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
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Ponce, Porto Rico, 00716
- Ponce Med School Found Inc
-
-
-
-
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Bristol, Regno Unito, BS37 4AX
- West Walk Surgery
-
Cambridge, Regno Unito, CB2 0QQ
- Addenbrooke's Hospital_Cambridge
-
Chippenham, Regno Unito, SN14 6GT
- Hathaway Medical Centre
-
Harrow, Regno Unito, HA3 7LT
- Belmont Health Centre
-
Hounslow, Regno Unito, TW4 7NJ
- HMC Health - Heston - The Meadows Centre for Health
-
London, Regno Unito, EC1M 6BQ
- William Harvey Research Institute
-
London, Regno Unito, SW1P 2PF
- Healthcare Central London - South Westminster Centre for Health
-
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Cambridgeshire
-
Wisbech, Cambridgeshire, Regno Unito, PE13 3UZ
- Trinity Surgery
-
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Cornwall
-
Newquay, Cornwall, Regno Unito, TR7 1RU
- Newquay Health Centre
-
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Hertfordshire
-
Bushey, Hertfordshire, Regno Unito, WD23 2NN
- Attenborough Surgery
-
-
-
-
-
Badajoz, Spagna, 06080
- Hospital Universitario de Badajoz
-
Barcelona, Spagna, 08022
- Centro Médico Quirón-Teknon
-
Barcelona, Spagna, 08036
- Clinic Barcelona_Endocrinología
-
León, Spagna, 24008
- H. de León_Endocrinología
-
Madrid, Spagna, 28016
- Hospital Universitario Sanitas Virgen del Mar
-
Madrid, Spagna, 28009
- H.G.Marañón_Endocrino-Obesidad
-
Santander, Spagna, 39008
- H. Univ. Marqués de Valdecilla_Endocrinología
-
Santiago de Compostela, Spagna, 15702
- Clínica Gaias Santiago
-
-
-
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California
-
Concord, California, Stati Uniti, 94520
- John Muir Physicians Network
-
Costa Mesa, California, Stati Uniti, 92627
- Aurora FDRC Inc.
-
Fullerton, California, Stati Uniti, 92835
- Providence Medical Foundation
-
Montclair, California, Stati Uniti, 91763
- Catalina Research Institute, LLC
-
Palm Springs, California, Stati Uniti, 92262
- Desert Oasis Hlthcr Med Group
-
San Dimas, California, Stati Uniti, 91773
- N America Res Inst - San Dimas
-
-
Connecticut
-
Waterbury, Connecticut, Stati Uniti, 06708
- Chase Medical Research LLC
-
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Florida
-
Clearwater, Florida, Stati Uniti, 33765
- Clinical Res Of W Florida Inc
-
Ocala, Florida, Stati Uniti, 34470
- Renstar Medical Research
-
Orlando, Florida, Stati Uniti, 32825
- Florida Institute for Clinical research
-
-
Georgia
-
Albany, Georgia, Stati Uniti, 31707
- Javara Inc. / Privia Medical Group Georgia LLC
-
Conyers, Georgia, Stati Uniti, 30094
- Hope Clin Res & Wellness
-
Roswell, Georgia, Stati Uniti, 30076
- Endocrine Research Solutions, Inc
-
Savannah, Georgia, Stati Uniti, 31406
- Javara Inc. / Privia Medical Group Georgia LLC
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60640
- Great Lakes Clinical Trials
-
Morton, Illinois, Stati Uniti, 61550
- Koch Research
-
Skokie, Illinois, Stati Uniti, 60077
- Evanston Premier Hlthcr Res
-
Skokie, Illinois, Stati Uniti, 60077
- Endeavor Health
-
Springfield, Illinois, Stati Uniti, 62702
- SIU Medicine
-
-
Indiana
-
Indianapolis, Indiana, Stati Uniti, 46260
- Midwest Inst For Clin Res
-
-
Iowa
-
West Des Moines, Iowa, Stati Uniti, 50266
- Iowa Diabetes Research
-
-
Kentucky
-
Bowling Green, Kentucky, Stati Uniti, 42101
- Graves Gibert Clinic
-
Louisville, Kentucky, Stati Uniti, 40213
- Monroe Biomedical Research, LLC
-
-
Michigan
-
Buckley, Michigan, Stati Uniti, 49620
- Northern Pines Hlth Ctr, PC
-
Flint, Michigan, Stati Uniti, 48504
- Aa Mrc Llc
-
-
Missouri
-
City of Saint Peters, Missouri, Stati Uniti, 63303
- StudyMetrix Research LLC
-
St Louis, Missouri, Stati Uniti, 63128
- Amicis Centers of Clinical Research
-
-
New Hampshire
-
Portsmouth, New Hampshire, Stati Uniti, 03801
- Seacoast Kidney & Htn Specialists
-
-
New York
-
West Seneca, New York, Stati Uniti, 14224
- Southgate Medical Group, LLP
-
Westfield, New York, Stati Uniti, 14787
- Great Lakes Medical Research
-
-
North Carolina
-
Raleigh, North Carolina, Stati Uniti, 27609
- Medication Management, LLC
-
Raleigh, North Carolina, Stati Uniti, 27609
- Accellacare_NC
-
Statesville, North Carolina, Stati Uniti, 28625
- Piedmont Healthcare, Inc.
-
-
Ohio
-
Canton, Ohio, Stati Uniti, 44718
- Diab & Endo Assoc of Stark Co
-
Wadsworth, Ohio, Stati Uniti, 44281-9236
- Family Practice Center of Wadsworth Inc.
-
-
Oklahoma
-
Norman, Oklahoma, Stati Uniti, 73072
- Lynn Institute of Norman
-
-
Rhode Island
-
Cumberland, Rhode Island, Stati Uniti, 02864
- Clinical Res Collaborative
-
-
South Carolina
-
North Charleston, South Carolina, Stati Uniti, 29405
- Coastal Carolina Res Ctr
-
Spartanburg, South Carolina, Stati Uniti, 29303
- Spartanburg Medical Research
-
-
Tennessee
-
Bristol, Tennessee, Stati Uniti, 37620
- Holston Medical Group Pc
-
Kingsport, Tennessee, Stati Uniti, 37660
- Holston Medical Group
-
Nashville, Tennessee, Stati Uniti, 37203
- Clinical Research Associates
-
-
Texas
-
Amarillo, Texas, Stati Uniti, 79124
- Amarillo Med Spec LLP
-
Austin, Texas, Stati Uniti, 78731
- Texas Diabetes & Endocrinology
-
Austin, Texas, Stati Uniti, 78749
- Texas Diabetes & Endocrinology, P.A._Austin
-
Bellaire, Texas, Stati Uniti, 77401
- Juno Research, LLC
-
Dallas, Texas, Stati Uniti, 75231
- North Texas Endocrine Center
-
Dallas, Texas, Stati Uniti, 75226
- Baylor Jack and Jane Hamilton
-
Dallas, Texas, Stati Uniti, 75230
- Velocity Clin Res, Dallas
-
Houston, Texas, Stati Uniti, 77079
- The Endocrine Center
-
Houston, Texas, Stati Uniti, 77036
- Discovery MM Services Inc
-
Lampasas, Texas, Stati Uniti, 76550
- Radiance Clinical Research
-
Longview, Texas, Stati Uniti, 75605
- DCOL Ctr for Clin Res
-
San Antonio, Texas, Stati Uniti, 78212
- Clinical Advancement Center
-
San Antonio, Texas, Stati Uniti, 78233
- Northeast Clinical Research of San Antonio
-
Shavano Park, Texas, Stati Uniti, 78231
- Consano Clinical Research, LLC
-
-
Washington
-
Renton, Washington, Stati Uniti, 98057
- Rainier Clin Res Ctr Inc
-
-
-
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Gauteng
-
Johannesburg, Gauteng, Sud Africa, 2013
- Wits Bara Clinical Trial Site
-
Johannesburg, Gauteng, Sud Africa, 1818
- Soweto Clinical Trial Centre
-
Midrand, Gauteng, Sud Africa, 1685
- Dr A Jacovides and Partners Inc
-
-
KwaZulu-Natal
-
Durban, KwaZulu-Natal, Sud Africa, 4091
- Dr Vawda's site
-
eMkhomazi, KwaZulu-Natal, Sud Africa, 4170
- Dr T Padayachee
-
-
Lenasia
-
Gauteng, Lenasia, Sud Africa, 1827
- Dr Moosa's Rooms
-
-
-
-
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Budapest, Ungheria, H-1141
- Cardiogeneral Kft.
-
Budapest, Ungheria, 1046
- Újpesti Egészségközpont
-
Budapest, Ungheria, H-1021
- Budapesti Szent Ferenc Kórház
-
Békéscsaba, Ungheria, 5600
- Trial Pharma Kft.
-
Békéscsaba, Ungheria, 5600
- Békés Vármegyei Központi Kórház
-
Szeged, Ungheria, 6724
- KomplexLabor Diagnosztika Kft.
-
-
Bács-Kiskun county
-
Kalocsa, Bács-Kiskun county, Ungheria, 6300
- Stúdium Egészségház Kft.
-
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Hajdú-Bihar
-
Debrecen, Hajdú-Bihar, Ungheria, 4032
- Debreceni Egyetem
-
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Numero di armi
4
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: CagriSema
Participants will receive CagriSema subcutaneously once weekly. |
CagriSema will be administered subcutaneously. |
|
Comparatore attivo: Semaglutide
Participants will receive semaglutide subcutaneously once weekly. |
Semaglutide will be administered subcutaneously. |
|
Comparatore attivo: Cagrilintide
Participants will receive cagrilintide subcutaneously once weekly. |
Cagrilintide will be administered subcutaneously. |
|
Comparatore placebo: Placebo
Participants will receive placebo subcutaneously once weekly. |
Placebo will be administered subcutaneously. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP)
Lasso di tempo: From baseline (week 0) to week 32
|
Measured in millimeters of mercury (mmHg). |
From baseline (week 0) to week 32
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
CagriSema versus Semaglutide and Cagrilintide : Change in in-office systolic blood pressure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At Week 32
|
Measured as Count of participants. |
At Week 32
|
|
Change in body weight (%)
Lasso di tempo: From baseline (week 0) to week 32
|
Measured in percentage (%). |
From baseline (week 0) to week 32
|
|
Change in body weight (Kg)
Lasso di tempo: From baseline (week 0) to week 32
|
Measured in Kilograms (kg). |
From baseline (week 0) to week 32
|
|
Change in waist circumference
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: HDL cholesterol
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: Triglycerides
Lasso di tempo: 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)
Lasso di tempo: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
Inizio studio
11 novembre 2026
Completamento primario (Stimato)
Completamento primario
1 giugno 2028
Completamento dello studio (Stimato)
Completamento dello studio
13 luglio 2028
Date di iscrizione allo studio
Primo inviato
Primo inviato
30 ottobre 2026
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
30 ottobre 2026
Primo Inserito (Effettivo)
Primo Inserito
5 novembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
5 novembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 ottobre 2026
Ultimo verificato
Ultimo verificato
1 ottobre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- NN9838-8768
- U1111-1338-1943 (Altro identificatore: World Health Organization (WHO))
- 2026-526360-21 (Altro identificatore: European Medical Agency (EMA))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .