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

October 30, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1408

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CagriSema

Participants will receive CagriSema subcutaneously once weekly.
Drug: CagriSema

CagriSema will be administered subcutaneously.
Active Comparator: Semaglutide

Participants will receive semaglutide subcutaneously once weekly.
Drug: Semaglutide

Semaglutide will be administered subcutaneously.
Active Comparator: Cagrilintide

Participants will receive cagrilintide subcutaneously once weekly.
Drug: Cagrilintide

Cagrilintide will be administered subcutaneously.
Placebo Comparator: Placebo

Participants will receive placebo subcutaneously once weekly.
Drug: Placebo

Placebo will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP)
Time Frame: From baseline (week 0) to week 32

Measured in millimeters of mercury (mmHg).
From baseline (week 0) to week 32

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CagriSema versus Semaglutide and Cagrilintide : Change in in-office systolic blood pressure
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: At Week 32

Measured as Count of participants.
At Week 32
Change in body weight (%)
Time Frame: From baseline (week 0) to week 32

Measured in percentage (%).
From baseline (week 0) to week 32
Change in body weight (Kg)
Time Frame: From baseline (week 0) to week 32

Measured in Kilograms (kg).
From baseline (week 0) to week 32
Change in waist circumference
Time Frame: 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
Time Frame: 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
Time Frame: From baseline (week 0) to week 32

Measured in Ratio.
From baseline (week 0) to week 32
Ratio to baseline of lipids: HDL cholesterol
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: From baseline (week 0) to week 32

Measured in Ratio.
From baseline (week 0) to week 32
Ratio to baseline of lipids: Triglycerides
Time Frame: 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)
Time Frame: From baseline (week 0) to week 32

Measured in Ratio.
From baseline (week 0) to week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9838-8768
  • U1111-1338-1943 (Other Identifier: World Health Organization (WHO))
  • 2026-526360-21 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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