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A Research Study to Investigate How Well the Medicine CagriSema Lowers High Blood Pressure in People Living With High Blood Pressure and Obesity (REDEFINE)

2026年10月30日更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

1408

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Novo Nordisk
电话号码：(+1) 866-867-7178
邮箱：clinicaltrials@novonordisk.com

学习地点

丹麦
- - Herning、丹麦、7400
    - Regionshospitalet Gødstrup - Universitetsklinikken for Nyresygdomme og Blodtryksforhøjelse
  - Holbæk、丹麦、4300
    - Holbæk Sygehus - Forskningsenheden, Medicinsk Afdeling, afs. 44-4
  - Hvidovre、丹麦、2650
    - Hvidovre Hospital Endokrinologisk forsknings afsnit 159
  - Viborg、丹麦、8800
    - Viborg Sygehus
- Region Syddanmark
  - Esbjerg、Region Syddanmark、丹麦、6700
    - Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
保加利亚
- - Burgas、保加利亚、8000
    - Medical center Medconsult Burgas OOD
  - Panagyurishte、保加利亚、4500
    - MHAT - Uni Hospital OOD, Clinic of Cardiology
  - Pernik、保加利亚、2308
    - MHAT Rahila Angelova AD, Research Center
  - Plovdiv、保加利亚、4002
    - Dr. Ilcho Ilchev - AIPSMC - Cardiology EOOD
  - Shumen、保加利亚、9700
    - MHAT Shumen AD
  - Sliven、保加利亚、8800
    - GPSMC - Inacor OOD
  - Sofia、保加利亚、1202
    - DCC Ascendent OOD
  - Sofia、保加利亚、1231
    - MC Dr. Atanasov EOOD
  - Sofia、保加利亚、1510
    - MC Hera EOOD - Sofia
  - Sofia、保加利亚、1431
    - UMHAT Aleksandrovska EAD, Clinic of Cardiology
  - Sofia、保加利亚、1750
    - MHAT Sveta Anna Sofia AD, Clinic of Cardiology
  - Sofia、保加利亚、1527
    - UMHAT Tsaritsa Yoanna - ISUL EAD, Cardiology
  - Sofia、保加利亚、1612
    - Nevrovita - Medical Center OOD
  - Varna、保加利亚、9010
    - UMHAT Sveta Marina EAD, Clinic of Internal Diseases
  - Varna、保加利亚、9009
    - SHATC - Cardiolife OOD - Varna
加拿大
- - Québec、加拿大、G1V 4T3
    - Diex Recherche Quebec
  - Québec、加拿大、G1V 4G5
    - IUCPQ - Universite Laval
- British Columbia
  - Vancouver、British Columbia、加拿大、V6Z 2T1
    - Spectrum Health Clinic
  - Victoria、British Columbia、加拿大、V8V 4A1
    - Dr. M.B. Jones Inc
- New Brunswick
  - Moncton、New Brunswick、加拿大、E1G 1A7
    - G.A. Research Associates Ltd.
- Nova Scotia
  - Halifax、Nova Scotia、加拿大、B3H 1V7
    - Nova Scotia Health Authority
- Ontario
  - Hamilton、Ontario、加拿大、L8L 5G4
    - Premier Clinical Trial Research Network (PCTRN)
  - Hamilton、Ontario、加拿大、L8L 5G4
    - Hamilton Medical Research Group
  - London、Ontario、加拿大、N5W 6A2
    - Milestone Research
- Quebec
  - Trois-Rivières、Quebec、加拿大、G9A 4P3
    - Diex Recherche Trois-Rivieres
匈牙利
- - Budapest、匈牙利、H-1141
    - Cardiogeneral Kft.
  - Budapest、匈牙利、1046
    - Újpesti Egészségközpont
  - Budapest、匈牙利、H-1021
    - Budapesti Szent Ferenc Kórház
  - Békéscsaba、匈牙利、5600
    - Trial Pharma Kft.
  - Békéscsaba、匈牙利、5600
    - Békés Vármegyei Központi Kórház
  - Szeged、匈牙利、6724
    - KomplexLabor Diagnosztika Kft.
- Bács-Kiskun county
  - Kalocsa、Bács-Kiskun county、匈牙利、6300
    - Stúdium Egészségház Kft.
- Hajdú-Bihar
  - Debrecen、Hajdú-Bihar、匈牙利、4032
    - Debreceni Egyetem
南非
- Gauteng
  - Johannesburg、Gauteng、南非、2013
    - Wits Bara Clinical Trial Site
  - Johannesburg、Gauteng、南非、1818
    - Soweto Clinical Trial Centre
  - Midrand、Gauteng、南非、1685
    - Dr A Jacovides and Partners Inc
- KwaZulu-Natal
  - Durban、KwaZulu-Natal、南非、4091
    - Dr Vawda's site
  - eMkhomazi、KwaZulu-Natal、南非、4170
    - Dr T Padayachee
- Lenasia
  - Gauteng、Lenasia、南非、1827
    - Dr Moosa's Rooms
巴西
- Minas Gerais
  - Belo Horizonte、Minas Gerais、巴西、30455-610
    - Centro Universitário de Belo Horizonte (UNIBH)
- Paraná
  - Curitiba、Paraná、巴西、80230-130
    - PUCPR - Pontificia Universidade Catolica do Parana
- São Paulo
  - Bragança Paulista、São Paulo、巴西、12916-542
    - Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista
  - Campinas、São Paulo、巴西、13092-133
    - i9 Pesquisas Clínicas
  - Campinas、São Paulo、巴西、13060-803
    - PUCCAMP - Hospital e Maternidade Celso Pierro
  - Campinas、São Paulo、巴西、13083-887
    - Centro de Pesquisa Clínica da Faculdade de Ciências Médicas - Unicamp
  - São Paulo、São Paulo、巴西、05403-000
    - Instituto do Coração - HCFMUSP
  - São Paulo、São Paulo、巴西、04038-032
    - IBTED Tecnologia e Educação em Diabetes - EPP
  - São Paulo、São Paulo、巴西、01228-000
    - CPQuali Pesquisa Clínica Ltda
德国
- - Berlin、德国、13405
    - KARDIA - Dr. Hashemi
  - Duisburg、德国、47269
    - MVZ Hausärzte Großenbaum GmbH Duisburg
  - Elsterwerda、德国、04910
    - Zentrum für klinische Studien Südbrandenburg GmbH
  - Frankfurt、德国、60590
    - Uniklinik FFM - Nephrologie
  - Hamburg、德国、22607
    - Wendisch - Dahl Hamburg - DZHW
  - Münster、德国、48145
    - Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
  - Oldenburg in Holstein、德国、23758
    - RED-Institut für medizinische Forschung und Fortbildung GmbH
意大利
- Apulia
  - Bari、Apulia、意大利、70124
    - AUO Consorziale Policlinico Bari - UOC Medicina Interna Universitaria (Cesare Frugoni)
- Calabria
  - Catanzaro、Calabria、意大利、88100
    - AOU Renato Dulbecco - Unità Operativa Complessa Medicina Interna
- Emilia-Romagna
  - Ferrara、Emilia-Romagna、意大利、44124
    - Arcispedale Sant'Anna (Cona) - Medicina Interna Universitaria
- Lazio
  - Rome、Lazio、意大利、00189
    - Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Cardiologia
- Lombardy
  - Brescia、Lombardy、意大利、25123
    - Spedali Civili Brescia - U.O. Medicina Generale 2
  - Milan、Lombardy、意大利、20162
    - Grande Ospedale Metropolitano Niguarda - Dipartimento di Cardiologia Clinica
- Molise
  - Pozzilli (IS)、Molise、意大利、86077
    - NeuroMed S.p.A. - Dipartimento di Angio-Cardio-Neurologia
- RM
  - Rome、RM、意大利、00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCS
- Sicily
  - Palermo、Sicily、意大利、90127
    - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- The Marches
  - Ancorna、The Marches、意大利、60127
    - INRCA Ancona - UOC Clinica Medica e Geriatrica
- Tuscany
  - Siena、Tuscany、意大利、53100
    - Azienda Ospedaliero Universitaria Senese - Endocrinologia
- Veneto
  - Padova、Veneto、意大利、35128
    - Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica
日本
- - Arakawa-ku, Tokyo、日本、116-0012
    - Kumanomae Nishimura Naika Clinic_Internal Medicine
  - Okayama、日本、700-8558
    - Okayama University Hospital_Neph. and Diabetes, Metabolism
  - Sendai-shi, Miyagi、日本、983-0039
    - Shinden Higashi Clinic_Internal medicine
  - Tokyo、日本、103-0027
    - Tokyo-Eki Center-building Clinic_Internal Medicine
  - Tokyo、日本、104-0031
    - Fukuwa Clinic_Internal Medicine
  - Tokyo、日本、160-0004
    - Clinical Research Hospital Tokyo_Internal medicine
- Kanagawa
  - Yamato-shi、Kanagawa、日本、242-0004
    - Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
比利时
- - Alken、比利时、3570
    - Anima Research Center
  - Bonheiden、比利时、2820
    - Imelda
  - Genk、比利时、3600
    - Ziekenhuis Oost-Limburg
  - Ghent、比利时、9000
    - Universitair Ziekenhuis Gent
  - Leuven、比利时、3000
    - Uz Leuven
  - Mons、比利时、7000
    - CHU Helora - Hôpital de Mons - Site Constantinople
波兰
- - Elblag、波兰、82-300
    - Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
  - Gdansk、波兰、80-214
    - Uniwersyteckie Centrum Kliniczne
  - Gdansk、波兰、80-462
    - Copernicus Podmiot Leczniczy Sp. z o.o.
  - Krakow、波兰、30-721
    - Linden sp. z o.o. sp. k.
  - Krakow、波兰、31-322
    - Gyncentrum Sp. z o. o.
  - Lodz、波兰、93-513
    - Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
  - Rzeszów、波兰、35-205
    - EMED Centrum Usług Medycznych Ewa Smialek
  - Siedlce、波兰、08-110
    - Lukmed 2 Sp. z o.o.
  - Starachowice、波兰、27-200
    - Star Badania Kliniczne Sp. z o.o
  - Warsaw、波兰、04-628
    - Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
  - Świnoujście、波兰、72-600
    - Balticmed Świnoujście Sp. z o. o.
- Masovian Voivodeship
  - Grodzisk Mazowiecki、Masovian Voivodeship、波兰、05-825
    - Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II
  - Ostrów Mazowiecka、Masovian Voivodeship、波兰、07-300
    - Kresmed Sp. z o. o.
  - Warsaw、Masovian Voivodeship、波兰、04-635
    - Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Pomeranian Voivodeship
  - Gdynia、Pomeranian Voivodeship、波兰、81-157
    - Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
波多黎各
- - Ponce、波多黎各、00716
    - Ponce Med School Found Inc
澳大利亚
- New South Wales
  - Castle Hill、New South Wales、澳大利亚、2154
    - Castle Hill Medical Centre
  - Darlinghurst、New South Wales、澳大利亚、2010
    - Momentum Clinical Research Darlinghurst
  - Maroubra、New South Wales、澳大利亚、2035
    - Australian Clinical Research Network
  - Sydney、New South Wales、澳大利亚、2148
    - Roger Chih Yu Chen
- Queensland
  - Douglas、Queensland、澳大利亚、4814
    - Townsville University Hospital
- Victoria
  - Torquay、Victoria、澳大利亚、3228
    - Clinical Trials Institute
- Western Australia
  - Bunbury、Western Australia、澳大利亚、6230
    - Brecken Health Clinical Trials
  - Perth、Western Australia、澳大利亚、6000
    - Dobney Hypertension Centre
美国
- California
  - Concord、California、美国、94520
    - John Muir Physicians Network
  - Costa Mesa、California、美国、92627
    - Aurora FDRC Inc.
  - Fullerton、California、美国、92835
    - Providence Medical Foundation
  - Montclair、California、美国、91763
    - Catalina Research Institute, LLC
  - Palm Springs、California、美国、92262
    - Desert Oasis Hlthcr Med Group
  - San Dimas、California、美国、91773
    - N America Res Inst - San Dimas
- Connecticut
  - Waterbury、Connecticut、美国、06708
    - Chase Medical Research LLC
- Florida
  - Clearwater、Florida、美国、33765
    - Clinical Res Of W Florida Inc
  - Ocala、Florida、美国、34470
    - Renstar Medical Research
  - Orlando、Florida、美国、32825
    - Florida Institute for Clinical research
- Georgia
  - Albany、Georgia、美国、31707
    - Javara Inc. / Privia Medical Group Georgia LLC
  - Conyers、Georgia、美国、30094
    - Hope Clin Res & Wellness
  - Roswell、Georgia、美国、30076
    - Endocrine Research Solutions, Inc
  - Savannah、Georgia、美国、31406
    - Javara Inc. / Privia Medical Group Georgia LLC
- Illinois
  - Chicago、Illinois、美国、60640
    - Great Lakes Clinical Trials
  - Morton、Illinois、美国、61550
    - Koch Research
  - Skokie、Illinois、美国、60077
    - Evanston Premier Hlthcr Res
  - Skokie、Illinois、美国、60077
    - Endeavor Health
  - Springfield、Illinois、美国、62702
    - SIU Medicine
- Indiana
  - Indianapolis、Indiana、美国、46260
    - Midwest Inst For Clin Res
- Iowa
  - West Des Moines、Iowa、美国、50266
    - Iowa Diabetes Research
- Kentucky
  - Bowling Green、Kentucky、美国、42101
    - Graves Gibert Clinic
  - Louisville、Kentucky、美国、40213
    - Monroe Biomedical Research, LLC
- Michigan
  - Buckley、Michigan、美国、49620
    - Northern Pines Hlth Ctr, PC
  - Flint、Michigan、美国、48504
    - Aa Mrc Llc
- Missouri
  - City of Saint Peters、Missouri、美国、63303
    - StudyMetrix Research LLC
  - St Louis、Missouri、美国、63128
    - Amicis Centers of Clinical Research
- New Hampshire
  - Portsmouth、New Hampshire、美国、03801
    - Seacoast Kidney & Htn Specialists
- New York
  - West Seneca、New York、美国、14224
    - Southgate Medical Group, LLP
  - Westfield、New York、美国、14787
    - Great Lakes Medical Research
- North Carolina
  - Raleigh、North Carolina、美国、27609
    - Medication Management, LLC
  - Raleigh、North Carolina、美国、27609
    - Accellacare_NC
  - Statesville、North Carolina、美国、28625
    - Piedmont Healthcare, Inc.
- Ohio
  - Canton、Ohio、美国、44718
    - Diab & Endo Assoc of Stark Co
  - Wadsworth、Ohio、美国、44281-9236
    - Family Practice Center of Wadsworth Inc.
- Oklahoma
  - Norman、Oklahoma、美国、73072
    - Lynn Institute of Norman
- Rhode Island
  - Cumberland、Rhode Island、美国、02864
    - Clinical Res Collaborative
- South Carolina
  - North Charleston、South Carolina、美国、29405
    - Coastal Carolina Res Ctr
  - Spartanburg、South Carolina、美国、29303
    - Spartanburg Medical Research
- Tennessee
  - Bristol、Tennessee、美国、37620
    - Holston Medical Group Pc
  - Kingsport、Tennessee、美国、37660
    - Holston Medical Group
  - Nashville、Tennessee、美国、37203
    - Clinical Research Associates
- Texas
  - Amarillo、Texas、美国、79124
    - Amarillo Med Spec LLP
  - Austin、Texas、美国、78731
    - Texas Diabetes & Endocrinology
  - Austin、Texas、美国、78749
    - Texas Diabetes & Endocrinology, P.A._Austin
  - Bellaire、Texas、美国、77401
    - Juno Research, LLC
  - Dallas、Texas、美国、75231
    - North Texas Endocrine Center
  - Dallas、Texas、美国、75226
    - Baylor Jack and Jane Hamilton
  - Dallas、Texas、美国、75230
    - Velocity Clin Res, Dallas
  - Houston、Texas、美国、77079
    - The Endocrine Center
  - Houston、Texas、美国、77036
    - Discovery MM Services Inc
  - Lampasas、Texas、美国、76550
    - Radiance Clinical Research
  - Longview、Texas、美国、75605
    - DCOL Ctr for Clin Res
  - San Antonio、Texas、美国、78212
    - Clinical Advancement Center
  - San Antonio、Texas、美国、78233
    - Northeast Clinical Research of San Antonio
  - Shavano Park、Texas、美国、78231
    - Consano Clinical Research, LLC
- Washington
  - Renton、Washington、美国、98057
    - Rainier Clin Res Ctr Inc
英国
- - Bristol、英国、BS37 4AX
    - West Walk Surgery
  - Cambridge、英国、CB2 0QQ
    - Addenbrooke's Hospital_Cambridge
  - Chippenham、英国、SN14 6GT
    - Hathaway Medical Centre
  - Harrow、英国、HA3 7LT
    - Belmont Health Centre
  - Hounslow、英国、TW4 7NJ
    - HMC Health - Heston - The Meadows Centre for Health
  - London、英国、EC1M 6BQ
    - William Harvey Research Institute
  - London、英国、SW1P 2PF
    - Healthcare Central London - South Westminster Centre for Health
- Cambridgeshire
  - Wisbech、Cambridgeshire、英国、PE13 3UZ
    - Trinity Surgery
- Cornwall
  - Newquay、Cornwall、英国、TR7 1RU
    - Newquay Health Centre
- Hertfordshire
  - Bushey、Hertfordshire、英国、WD23 2NN
    - Attenborough Surgery
荷兰
- - Deventer、荷兰、7416 SE
    - Deventer Ziekenhuis - Interne geneeskunde
  - Dordrecht、荷兰、3318 AT
    - Albert Schweitzer Zkh, Dordwijk - Nefrologie
  - Eindhoven、荷兰、5623 EJ
    - Catharina Zkh Eindhoven - Interne geneeskunde
  - Haarlem、荷兰、2035 RC
    - Spaarne Gasthuis Haarlem - Interne
  - Heerlen、荷兰、6419 PC
    - Zuyderland ziekenhuis - Interne
  - Hoogeveen、荷兰、7909 AA
    - Bethesda Diabetes Research Center
  - Nijmegen、荷兰、6525 GA
    - RadboudUMC - Vasculaire geneeskunde
  - Utrecht、荷兰、3584 CX
    - UMC Utrecht - Vasculaire geneeskunde
西班牙
- - Badajoz、西班牙、06080
    - Hospital Universitario de Badajoz
  - Barcelona、西班牙、08022
    - Centro Médico Quirón-Teknon
  - Barcelona、西班牙、08036
    - Clinic Barcelona_Endocrinología
  - León、西班牙、24008
    - H. de León_Endocrinología
  - Madrid、西班牙、28016
    - Hospital Universitario Sanitas Virgen del Mar
  - Madrid、西班牙、28009
    - H.G.Marañón_Endocrino-Obesidad
  - Santander、西班牙、39008
    - H. Univ. Marqués de Valdecilla_Endocrinología
  - Santiago de Compostela、西班牙、15702
    - Clínica Gaias Santiago
阿根廷
- - Buenos Aires、阿根廷、C1425AGC
    - Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
  - CABA、阿根廷、C1060ABA
    - CEDIC Centro de Investigación Clínica
  - CABA、阿根廷、C1120AAC
    - Centro Médico Viamonte SRL
  - Rosario、阿根廷、S2000PBJ
    - CAICI
  - Santiago del Estero、阿根廷、G4200
    - Sanatorio Norte
- Buenos Aires
  - CABA、Buenos Aires、阿根廷、C1128 AAF
    - Mautalen Salud e investigación
  - CABA、Buenos Aires、阿根廷、C1440CFD
    - CEMEDIC
  - Capital Federal、Buenos Aires、阿根廷、C1056ABI
    - Centro de Investigaciones Metabólicas
- La Pampa Province
  - Santa Rosa、La Pampa Province、阿根廷、6300
    - Fundación CESIM
- Mendoza Province
  - Godoy Cruz, Mendoza、Mendoza Province、阿根廷、5501
    - Hospital Español de Mendoza
韩国
- - Busan、韩国、49201
    - Dong-A University Hospital_Family Medicine
  - Daegu、韩国、41944
    - Kyungpook National University Hospital_Family Medicine
  - Daegu、韩国、42601
    - Keimyung University Dongsan Hospital_Endocrinology
  - Daejeon、韩国、35365
    - Konyang University Hospital_Family Medicine
  - Seoul、韩国、03722
    - Severance Hospital, Yonsei University Health System_Family Medicine
  - Seoul、韩国、04763
    - Hanyang University Seoul Hospital_Family Medicine
- Gyeonggi-do
  - Anyang-si、Gyeonggi-do、韩国、14068
    - Hallym University Sacred Heart Hospital_Family Medicine
  - Bucheon-si、Gyeonggi-do、韩国、14647
    - The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology
  - Seongnam-si、Gyeonggi-do、韩国、13620
    - Seoul National University Bundang Hospital_Family Medicine
- Gyeongsangnam-do
  - Yangsan、Gyeongsangnam-do、韩国、50612
    - Pusan National University Yangsan Hospital_Family Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：四人间

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：CagriSema Participants will receive CagriSema subcutaneously once weekly.	药品：CagriSema CagriSema will be administered subcutaneously.
有源比较器：Semaglutide Participants will receive semaglutide subcutaneously once weekly.	药品：Semaglutide Semaglutide will be administered subcutaneously.
有源比较器：Cagrilintide Participants will receive cagrilintide subcutaneously once weekly.	药品：Cagrilintide Cagrilintide will be administered subcutaneously.
安慰剂比较：Placebo Participants will receive placebo subcutaneously once weekly.	药品：Placebo Placebo will be administered subcutaneously.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP) 大体时间：From baseline (week 0) to week 32	Measured in millimeters of mercury (mmHg).	From baseline (week 0) to week 32

次要结果测量

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novo Nordisk A/S

调查人员

研究主任：Clinical Transparency (dept. 2834)、Novo Nordisk A/S

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月11日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年7月13日

研究注册日期

首次提交

2026年10月30日

首先提交符合 QC 标准的

2026年10月30日

首次发布 (实际的)

2026年11月5日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年10月30日

最后验证

2026年10月1日

结果测量	措施说明	大体时间
CagriSema versus Semaglutide and Cagrilintide : Change in in-office systolic blood pressure 大体时间：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 大体时间：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 大体时间：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 大体时间：At Week 32	Measured as Count of participants.	At Week 32
Change in body weight (%) 大体时间：From baseline (week 0) to week 32	Measured in percentage (%).	From baseline (week 0) to week 32
Change in body weight (Kg) 大体时间：From baseline (week 0) to week 32	Measured in Kilograms (kg).	From baseline (week 0) to week 32
Change in waist circumference 大体时间：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 大体时间：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 大体时间：From baseline (week 0) to week 32	Measured in Ratio.	From baseline (week 0) to week 32
Ratio to baseline of lipids: HDL cholesterol 大体时间：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 大体时间：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 大体时间：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 大体时间：From baseline (week 0) to week 32	Measured in Ratio.	From baseline (week 0) to week 32
Ratio to baseline of lipids: Triglycerides 大体时间：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) 大体时间：From baseline (week 0) to week 32	Measured in Ratio.	From baseline (week 0) to week 32

A Research Study to Investigate How Well the Medicine CagriSema Lowers High Blood Pressure in People Living With High Blood Pressure and Obesity (REDEFINE)

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) in Participants With Hypertension and Obesity

研究概览

地位

条件

干预/治疗

研究类型

注册 (估计的)

阶段

联系人和位置

学习联系方式

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (估计的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品