AzTrials
AzTrials

HypertensionPhase 3REDEFINENCT07919405

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

A Phase 3 study testing CagriSema, Semaglutide and Cagrilintide in people with Hypertension and Obesity, run by Novo Nordisk A/S at 212 sites in 19 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Obesity
What is being tested?
CagriSema, Semaglutide and Cagrilintide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,408 participants
Where
212 sitesin 19 countries
Study dates
11 Nov 2026to 13 Jul 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

212 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

212 sites in 19 countries

United States57 sites

  • Javara Inc. / Privia Medical Group Georgia LLC

    Albany, Georgia, 31707

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79124

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78731

  • Texas Diabetes & Endocrinology, P.A._Austin

    Austin, Texas, 78749

  • Juno Research, LLC

    Bellaire, Texas, 77401

  • Graves Gibert Clinic

    Bowling Green, Kentucky, 42101

  • Holston Medical Group Pc

    Bristol, Tennessee, 37620

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620

  • Diab & Endo Assoc of Stark Co

    Canton, Ohio, 44718

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • StudyMetrix Research LLC

    City of Saint Peters, Missouri, 63303

  • Clinical Res Of W Florida Inc

    Clearwater, Florida, 33765

  • John Muir Physicians Network

    Concord, California, 94520

  • Hope Clin Res & Wellness

    Conyers, Georgia, 30094

  • Aurora FDRC Inc.

    Costa Mesa, California, 92627

  • Clinical Res Collaborative

    Cumberland, Rhode Island, 02864

  • Baylor Jack and Jane Hamilton

    Dallas, Texas, 75226

  • Velocity Clin Res, Dallas

    Dallas, Texas, 75230

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • Aa Mrc Llc

    Flint, Michigan, 48504

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Discovery MM Services Inc

    Houston, Texas, 77036

  • The Endocrine Center

    Houston, Texas, 77079

  • Midwest Inst For Clin Res

    Indianapolis, Indiana, 46260

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Radiance Clinical Research

    Lampasas, Texas, 76550

  • DCOL Ctr for Clin Res

    Longview, Texas, 75605

  • Monroe Biomedical Research, LLC

    Louisville, Kentucky, 40213

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Koch Research

    Morton, Illinois, 61550

  • Clinical Research Associates

    Nashville, Tennessee, 37203

  • Lynn Institute of Norman

    Norman, Oklahoma, 73072

  • Coastal Carolina Res Ctr

    North Charleston, South Carolina, 29405

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Florida Institute for Clinical research

    Orlando, Florida, 32825

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California, 92262

  • Seacoast Kidney & Htn Specialists

    Portsmouth, New Hampshire, 03801

  • Accellacare_NC

    Raleigh, North Carolina, 27609

  • Medication Management, LLC

    Raleigh, North Carolina, 27609

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057

  • Endocrine Research Solutions, Inc

    Roswell, Georgia, 30076

  • Clinical Advancement Center

    San Antonio, Texas, 78212

  • Northeast Clinical Research of San Antonio

    San Antonio, Texas, 78233

  • N America Res Inst - San Dimas

    San Dimas, California, 91773

  • Javara Inc. / Privia Medical Group Georgia LLC

    Savannah, Georgia, 31406

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Endeavor Health

    Skokie, Illinois, 60077

  • Evanston Premier Hlthcr Res

    Skokie, Illinois, 60077

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • SIU Medicine

    Springfield, Illinois, 62702

  • Amicis Centers of Clinical Research

    St Louis, Missouri, 63128

  • Piedmont Healthcare, Inc.

    Statesville, North Carolina, 28625

  • Family Practice Center of Wadsworth Inc.

    Wadsworth, Ohio, 44281-9236

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708

  • Iowa Diabetes Research

    West Des Moines, Iowa, 50266

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224

  • Great Lakes Medical Research

    Westfield, New York, 14787

Other trials in United States

Bulgaria15 sites

  • Medical center Medconsult Burgas OOD

    Burgas, 8000

  • MHAT - Uni Hospital OOD, Clinic of Cardiology

    Panagyurishte, 4500

  • MHAT Rahila Angelova AD, Research Center

    Pernik, 2308

  • Dr. Ilcho Ilchev - AIPSMC - Cardiology EOOD

    Plovdiv, 4002

  • MHAT Shumen AD

    Shumen, 9700

  • GPSMC - Inacor OOD

    Sliven, 8800

  • DCC Ascendent OOD

    Sofia, 1202

  • MC Dr. Atanasov EOOD

    Sofia, 1231

  • UMHAT Aleksandrovska EAD, Clinic of Cardiology

    Sofia, 1431

  • MC Hera EOOD - Sofia

    Sofia, 1510

  • UMHAT Tsaritsa Yoanna - ISUL EAD, Cardiology

    Sofia, 1527

  • Nevrovita - Medical Center OOD

    Sofia, 1612

  • MHAT Sveta Anna Sofia AD, Clinic of Cardiology

    Sofia, 1750

  • SHATC - Cardiolife OOD - Varna

    Varna, 9009

  • UMHAT Sveta Marina EAD, Clinic of Internal Diseases

    Varna, 9010

Other trials in Bulgaria

Poland15 sites

  • Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska

    Elblag, 82-300

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Copernicus Podmiot Leczniczy Sp. z o.o.

    Gdansk, 80-462

  • Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman

    Gdynia, Pomeranian Voivodeship, 81-157

  • Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II

    Grodzisk Mazowiecki, Masovian Voivodeship, 05-825

  • Linden sp. z o.o. sp. k.

    Krakow, 30-721

  • Gyncentrum Sp. z o. o.

    Krakow, 31-322

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika

    Lodz, 93-513

  • Kresmed Sp. z o. o.

    Ostrów Mazowiecka, Masovian Voivodeship, 07-300

  • EMED Centrum Usług Medycznych Ewa Smialek

    Rzeszów, 35-205

  • Lukmed 2 Sp. z o.o.

    Siedlce, 08-110

  • Star Badania Kliniczne Sp. z o.o

    Starachowice, 27-200

  • Balticmed Świnoujście Sp. z o. o.

    Świnoujście, 72-600

  • Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

    Warsaw, Masovian Voivodeship, 04-635

  • Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

    Warsaw, 04-628

Other trials in Poland

Italy12 sites

  • INRCA Ancona - UOC Clinica Medica e Geriatrica

    Ancorna, The Marches, 60127

  • AUO Consorziale Policlinico Bari - UOC Medicina Interna Universitaria (Cesare Frugoni)

    Bari, Apulia, 70124

  • Spedali Civili Brescia - U.O. Medicina Generale 2

    Brescia, Lombardy, 25123

  • AOU Renato Dulbecco - Unità Operativa Complessa Medicina Interna

    Catanzaro, Calabria, 88100

  • Arcispedale Sant'Anna (Cona) - Medicina Interna Universitaria

    Ferrara, Emilia-Romagna, 44124

  • Grande Ospedale Metropolitano Niguarda - Dipartimento di Cardiologia Clinica

    Milan, Lombardy, 20162

  • Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica

    Padova, Veneto, 35128

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, Sicily, 90127

  • NeuroMed S.p.A. - Dipartimento di Angio-Cardio-Neurologia

    Pozzilli (IS), Molise, 86077

  • Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Cardiologia

    Rome, Lazio, 00189

  • Fondazione Policlinico Universitario Agostino Gemelli IRCS

    Rome, RM, 00168

  • Azienda Ospedaliero Universitaria Senese - Endocrinologia

    Siena, Tuscany, 53100

Other trials in Italy

Argentina10 sites

  • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

    Buenos Aires, C1425AGC

  • Mautalen Salud e investigación

    CABA, Buenos Aires, C1128 AAF

  • CEMEDIC

    CABA, Buenos Aires, C1440CFD

  • CEDIC Centro de Investigación Clínica

    CABA, C1060ABA

  • Centro Médico Viamonte SRL

    CABA, C1120AAC

  • Centro de Investigaciones Metabólicas

    Capital Federal, Buenos Aires, C1056ABI

  • Hospital Español de Mendoza

    Godoy Cruz, Mendoza, Mendoza Province, 5501

  • CAICI

    Rosario, S2000PBJ

  • Fundación CESIM

    Santa Rosa, La Pampa Province, 6300

  • Sanatorio Norte

    Santiago del Estero, G4200

Other trials in Argentina

Canada10 sites

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 1V7

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8L 5G4

  • Premier Clinical Trial Research Network (PCTRN)

    Hamilton, Ontario, L8L 5G4

  • Milestone Research

    London, Ontario, N5W 6A2

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

  • IUCPQ - Universite Laval

    Québec, G1V 4G5

  • Diex Recherche Quebec

    Québec, G1V 4T3

  • Diex Recherche Trois-Rivieres

    Trois-Rivières, Quebec, G9A 4P3

  • Spectrum Health Clinic

    Vancouver, British Columbia, V6Z 2T1

  • Dr. M.B. Jones Inc

    Victoria, British Columbia, V8V 4A1

Other trials in Canada

South Korea10 sites

  • Hallym University Sacred Heart Hospital_Family Medicine

    Anyang-si, Gyeonggi-do, 14068

  • The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology

    Bucheon-si, Gyeonggi-do, 14647

  • Dong-A University Hospital_Family Medicine

    Busan, 49201

  • Kyungpook National University Hospital_Family Medicine

    Daegu, 41944

  • Keimyung University Dongsan Hospital_Endocrinology

    Daegu, 42601

  • Konyang University Hospital_Family Medicine

    Daejeon, 35365

  • Seoul National University Bundang Hospital_Family Medicine

    Seongnam-si, Gyeonggi-do, 13620

  • Severance Hospital, Yonsei University Health System_Family Medicine

    Seoul, 03722

  • Hanyang University Seoul Hospital_Family Medicine

    Seoul, 04763

  • Pusan National University Yangsan Hospital_Family Medicine

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

United Kingdom10 sites

  • West Walk Surgery

    Bristol, BS37 4AX

  • Attenborough Surgery

    Bushey, Hertfordshire, WD23 2NN

  • Addenbrooke's Hospital_Cambridge

    Cambridge, CB2 0QQ

  • Hathaway Medical Centre

    Chippenham, SN14 6GT

  • Belmont Health Centre

    Harrow, HA3 7LT

  • HMC Health - Heston - The Meadows Centre for Health

    Hounslow, TW4 7NJ

  • William Harvey Research Institute

    London, EC1M 6BQ

  • Healthcare Central London - South Westminster Centre for Health

    London, SW1P 2PF

  • Newquay Health Centre

    Newquay, Cornwall, TR7 1RU

  • Trinity Surgery

    Wisbech, Cambridgeshire, PE13 3UZ

Other trials in United Kingdom

Brazil9 sites

  • Centro Universitário de Belo Horizonte (UNIBH)

    Belo Horizonte, Minas Gerais, 30455-610

  • Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista

    Bragança Paulista, São Paulo, 12916-542

  • PUCCAMP - Hospital e Maternidade Celso Pierro

    Campinas, São Paulo, 13060-803

  • Centro de Pesquisa Clínica da Faculdade de Ciências Médicas - Unicamp

    Campinas, São Paulo, 13083-887

  • i9 Pesquisas Clínicas

    Campinas, São Paulo, 13092-133

  • PUCPR - Pontificia Universidade Catolica do Parana

    Curitiba, Paraná, 80230-130

  • CPQuali Pesquisa Clínica Ltda

    São Paulo, São Paulo, 01228-000

  • IBTED Tecnologia e Educação em Diabetes - EPP

    São Paulo, São Paulo, 04038-032

  • Instituto do Coração - HCFMUSP

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Australia8 sites

  • Brecken Health Clinical Trials

    Bunbury, Western Australia, 6230

  • Castle Hill Medical Centre

    Castle Hill, New South Wales, 2154

  • Momentum Clinical Research Darlinghurst

    Darlinghurst, New South Wales, 2010

  • Townsville University Hospital

    Douglas, Queensland, 4814

  • Australian Clinical Research Network

    Maroubra, New South Wales, 2035

  • Dobney Hypertension Centre

    Perth, Western Australia, 6000

  • Roger Chih Yu Chen

    Sydney, New South Wales, 2148

  • Clinical Trials Institute

    Torquay, Victoria, 3228

Other trials in Australia

Hungary8 sites

  • Békés Vármegyei Központi Kórház

    Békéscsaba, 5600

  • Trial Pharma Kft.

    Békéscsaba, 5600

  • Újpesti Egészségközpont

    Budapest, 1046

  • Budapesti Szent Ferenc Kórház

    Budapest, H-1021

  • Cardiogeneral Kft.

    Budapest, H-1141

  • Debreceni Egyetem

    Debrecen, Hajdú-Bihar, 4032

  • Stúdium Egészségház Kft.

    Kalocsa, Bács-Kiskun county, 6300

  • KomplexLabor Diagnosztika Kft.

    Szeged, 6724

Other trials in Hungary

Netherlands8 sites

  • Deventer Ziekenhuis - Interne geneeskunde

    Deventer, 7416 SE

  • Albert Schweitzer Zkh, Dordwijk - Nefrologie

    Dordrecht, 3318 AT

  • Catharina Zkh Eindhoven - Interne geneeskunde

    Eindhoven, 5623 EJ

  • Spaarne Gasthuis Haarlem - Interne

    Haarlem, 2035 RC

  • Zuyderland ziekenhuis - Interne

    Heerlen, 6419 PC

  • Bethesda Diabetes Research Center

    Hoogeveen, 7909 AA

  • RadboudUMC - Vasculaire geneeskunde

    Nijmegen, 6525 GA

  • UMC Utrecht - Vasculaire geneeskunde

    Utrecht, 3584 CX

Other trials in Netherlands

Spain8 sites

  • Hospital Universitario de Badajoz

    Badajoz, 06080

  • Centro Médico Quirón-Teknon

    Barcelona, 08022

  • Clinic Barcelona_Endocrinología

    Barcelona, 08036

  • H. de León_Endocrinología

    León, 24008

  • H.G.Marañón_Endocrino-Obesidad

    Madrid, 28009

  • Hospital Universitario Sanitas Virgen del Mar

    Madrid, 28016

  • H. Univ. Marqués de Valdecilla_Endocrinología

    Santander, 39008

  • Clínica Gaias Santiago

    Santiago de Compostela, 15702

Other trials in Spain

Germany7 sites

  • KARDIA - Dr. Hashemi

    Berlin, 13405

  • MVZ Hausärzte Großenbaum GmbH Duisburg

    Duisburg, 47269

  • Zentrum für klinische Studien Südbrandenburg GmbH

    Elsterwerda, 04910

  • Uniklinik FFM - Nephrologie

    Frankfurt, 60590

  • Wendisch - Dahl Hamburg - DZHW

    Hamburg, 22607

  • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

    Münster, 48145

  • RED-Institut für medizinische Forschung und Fortbildung GmbH

    Oldenburg in Holstein, 23758

Other trials in Germany

Japan7 sites

  • Kumanomae Nishimura Naika Clinic_Internal Medicine

    Arakawa-ku, Tokyo, 116-0012

  • Okayama University Hospital_Neph. and Diabetes, Metabolism

    Okayama, 700-8558

  • Shinden Higashi Clinic_Internal medicine

    Sendai-shi, Miyagi, 983-0039

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031

  • Clinical Research Hospital Tokyo_Internal medicine

    Tokyo, 160-0004

  • Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

    Yamato-shi, Kanagawa, 242-0004

Other trials in Japan

Belgium6 sites

  • Anima Research Center

    Alken, 3570

  • Imelda

    Bonheiden, 2820

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Uz Leuven

    Leuven, 3000

  • CHU Helora - Hôpital de Mons - Site Constantinople

    Mons, 7000

Other trials in Belgium

South Africa6 sites

  • Dr Vawda's site

    Durban, KwaZulu-Natal, 4091

  • Dr T Padayachee

    eMkhomazi, KwaZulu-Natal, 4170

  • Dr Moosa's Rooms

    Gauteng, Lenasia, 1827

  • Soweto Clinical Trial Centre

    Johannesburg, Gauteng, 1818

  • Wits Bara Clinical Trial Site

    Johannesburg, Gauteng, 2013

  • Dr A Jacovides and Partners Inc

    Midrand, Gauteng, 1685

Other trials in South Africa

Denmark5 sites

  • Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden

    Esbjerg, Region Syddanmark, 6700

  • Regionshospitalet Gødstrup - Universitetsklinikken for Nyresygdomme og Blodtryksforhøjelse

    Herning, 7400

  • Holbæk Sygehus - Forskningsenheden, Medicinsk Afdeling, afs. 44-4

    Holbæk, 4300

  • Hvidovre Hospital Endokrinologisk forsknings afsnit 159

    Hvidovre, 2650

  • Viborg Sygehus

    Viborg, 8800

Other trials in Denmark

Puerto Rico1 site

  • Ponce Med School Found Inc

    Ponce, 00716

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
CagriSema, Semaglutide, Cagrilintide, Placebo
Medical subject headings
Hypertension, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CagriSemaDrug

    CagriSema will be administered subcutaneously.

  • SemaglutideDrug

    Semaglutide will be administered subcutaneously.

  • CagrilintideDrug

    Cagrilintide will be administered subcutaneously.

  • PlaceboDrug

    Placebo will be administered subcutaneously.

Study groups in NCT07919405
Study groupRoleWhat they receive
CagriSemaExperimentalParticipants will receive CagriSema subcutaneously once weekly.
Receives: Drug: CagriSema
SemaglutideActive comparatorParticipants will receive semaglutide subcutaneously once weekly.
Receives: Drug: Semaglutide
CagrilintideActive comparatorParticipants will receive cagrilintide subcutaneously once weekly.
Receives: Drug: Cagrilintide
PlaceboPlacebo comparatorParticipants will receive placebo subcutaneously once weekly.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP)

    Measured in millimeters of mercury (mmHg).

    Measured: From baseline (week 0) to week 32

Secondary outcomes (15)

  1. CagriSema versus Semaglutide and Cagrilintide : Change in in-office systolic blood pressure

    Measured in mmHg.

    Measured: From baseline (week 0) to week 32

  2. Change in Home blood pressure monitoring (HBPM) -based systolic blood pressure

    Measured in mmHg.

    Measured: From baseline (week 0) to week 32

  3. Number of participants who achieve a target goal of in-office systolic blood pressure lesser than or equal to (≤) 130 mmHg

    Measured as Count of participants.

    Measured: At Week 32

  4. 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

    Measured as Count of participants.

    Measured: At Week 32

  5. Change in body weight (%)

    Measured in percentage (%).

    Measured: From baseline (week 0) to week 32

  6. Change in body weight (Kg)

    Measured in Kilograms (kg).

    Measured: From baseline (week 0) to week 32

  7. Change in waist circumference

    Measured in centimetre (cm).

    Measured: From baseline (week 0) to week 32

  8. Change in ACC/AHA 10-year atherosclerotic cardiovascular disease (ASCVD) risk score

    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.

    Measured: From baseline (week 0) to week 32

  9. Ratio to baseline of lipids: Total cholesterol

    Measured in Ratio.

    Measured: From baseline (week 0) to week 32

  10. Ratio to baseline of lipids: HDL cholesterol

    Measured in Ratio.

    Measured: From baseline (week 0) to week 32

  11. Ratio to baseline of lipids: Low Density Lipoprotein (LDL) cholesterol

    Measured in Ratio.

    Measured: From baseline (week 0) to week 32

  12. Ratio to baseline of lipids: Very Low Density Lipoprotein (VLDL) cholesterol

    Measured in Ratio.

    Measured: From baseline (week 0) to week 32

  13. Ratio to baseline of lipids: Non-HDL cholesterol

    Measured in Ratio.

    Measured: From baseline (week 0) to week 32

  14. Ratio to baseline of lipids: Triglycerides

    Measured in Ratio.

    Measured: From baseline (week 0) to week 32

  15. Ratio to baseline of high-sensitivity C-reactive protein (hsCRP)

    Measured in Ratio.

    Measured: From baseline (week 0) to week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start11 Nov 2026 (estimated)
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion13 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,408 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07919405
Sponsor's protocol ID
NN9838-8768
Other IDs
U1111-1338-1943, 2026-526360-21
Acronym
REDEFINE
Status last verified
Oct 2026
First submitted
30 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CagriSema, Semaglutide and Cagrilintide in people with Hypertension and Obesity, run by Novo Nordisk A/S at 212 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 212 sites in United States, Bulgaria, Poland, Italy, Argentina and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP) (time frame: From baseline (week 0) to week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07919405.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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