REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels (REDEFINE 3)

May 18, 2026 updated by: Novo Nordisk A/S

The Cardiovascular Safety and Efficacy of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) Once-weekly in Participants With Established Cardiovascular Disease

This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years.

Study Overview

Status

Active, not recruiting

Study Type

Interventional

Enrollment (Actual)

7101

Phase

  • 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 Locations

      • Buenos Aires, Argentina, C1425AGC
        • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
      • Buenos Aires, Argentina, C1119ACN
        • CIPREC Pueyrredon
      • CABA, Argentina, C1060ABA
        • CEDIC Centro de Investigación Clínica
      • CABA, Argentina, C1440AAD
        • CENUDIAB Centro Médico de Nutrición v Diabetes
      • CABA, Argentina, C1440AAD
        • Medical Center of Diabetes and Nutrition
      • CABA, Argentina, C1061AAS.
        • CIPREC Arenales
      • Córdoba, Argentina, X5003DCE
        • Instituto Médico DAMIC
      • Córdoba, Argentina, X5006IKK
        • Centro Medico Privado San Vicente Diabetes
      • Morón, Argentina, B1708IFF
        • Consultorio Integral de Atención al Diabético
      • San Nicolás, Argentina, B2900
        • Instituto de Investigaciones Clinicas San Nicolas
      • 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 Plata, Buenos Aires, Argentina, B 1900AXI
        • Hospital Italiano de La Plata
      • Mar del Plata, Buenos Aires, Argentina, B7600FZN
        • Instituto de Investigaciones Clinicas Mar del Plata
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000
        • Instituto Medico Catamarca
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Gosford Renal Research
      • Kanwal, New South Wales, Australia, 2259
        • Paratus Clinical
      • Kogarah, New South Wales, Australia, 2217
        • Southern Neurology
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
      • Macquarie Park, New South Wales, Australia, 2109
        • Macquarie University - Clinical Trials Unit
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Advara HeartCare Auchenflower
      • Meadowbrook, Queensland, Australia, 4131
        • Logan Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Nightingale Research
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital - Cardiology Department
      • Leabrook, South Australia, Australia, 5068
        • Advara HeartCare Leabrook
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Baker Heart and Diabetes Institute
    • Western Australia
      • Joondalup, Western Australia, Australia, 6027
        • Advara HeartCare Joondalup
      • Nedlands, Western Australia, Australia, 6009
        • One Clinical Research
      • Perth, Western Australia, Australia, 6000
        • CliniTrials
      • West Perth, Western Australia, Australia, 6005
        • CliniTrials
      • Rio de Janeiro, Brazil, 22061-080
        • Hospital São Lucas Copacabana
      • São Paulo, Brazil, 04266-010
        • CEPIC - Centro Paulista de Investigacao Clinica
    • Amazonas
      • Manaus, Amazonas, Brazil, 69057-088
        • CPHosp Manaus Medicina, Ensino e Pesquisa LTDA
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-350
        • Centro de Pesquisa em Diabetes Doenças Endócrino-Metabólicas
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055-450
        • Centro de Diag. e Pesquisa da Osteoporose do Espírito Santo
    • Paraná
      • Curitiba, Paraná, Brazil, 80730-150
        • Núcleo de Pesquisa Clínica S/S
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
        • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
    • São Paulo
      • Campinas, São Paulo, Brazil, 13060-080
        • Instituto de Pesquisa Clinica de Campinas
      • Campinas, São Paulo, Brazil, 13092-133
        • i9 Pesquisas Clínicas
      • Campinas, São Paulo, Brazil, 13060-803
        • PUCCAMP - Hospital e Maternidade Celso Pierro
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • CIP Centro Integrado de Pesquisas do Hospital de Base
      • São José dos Campos, São Paulo, Brazil, 12243-280
        • Instituto São José dos Campos em Pesquisas Médicas
      • São Paulo, São Paulo, Brazil, 01228-200
        • CPCLIN - Centro de Pesquisas Clínicas
      • São Paulo, São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica Ltda
      • São Paulo, São Paulo, Brazil, 01223-001
        • Instituto de Pesquisa Clinica (IPEC)
      • Bankya, Bulgaria, 1320
        • SRH - Zdrave EAD
      • Burgas, Bulgaria, 8000
        • DCC - Burgas EOOD
      • Burgas, Bulgaria, 8000
        • IPSOMC - Dr. Georgi Marinov
      • Dimitrovgrad, Bulgaria, 6400
        • MC Diamedical - 2013 OOD, Dimitrovgrad
      • Haskovo, Bulgaria, 6300
        • AIPSMC - DiMed EOOD
      • Kozloduy, Bulgaria, 3320
        • Medical centre Zdrave 1 OOD
      • Panagyurishte, Bulgaria, 4500
        • MHAT - UniHospital OOD
      • Pazardzhik, Bulgaria, 4401
        • "MHAT - Pazardzhik"
      • Pazardzhik, Bulgaria, 4401
        • MHAT - Pazardzhik AD
      • Pleven, Bulgaria, 5800
        • Medical center Medconsult Pleven OOD
      • Pleven, Bulgaria, 5800
        • OCSOMCE - Dr. Albena Dinkova EOOD
      • Plovdiv, Bulgaria, 4000
        • DCC Pulmed EOOD
      • Plovdiv, Bulgaria, 4001
        • UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic
      • Plovdiv, Bulgaria, 4000
        • MHAT Med Line Clinic
      • Plovdiv, Bulgaria, 4002
        • UMHAT - Plovdiv AD
      • Plovdiv, Bulgaria, 4004
        • MHAT Sveta Karidad EAD
      • Plovdiv, Bulgaria, 4002
        • UMHAT Pulmed OOD - Plovdiv, Department of Endocrinology
      • Rousse, Bulgaria, 7013
        • UMHAT Medica - Ruse OOD
      • Samokov, Bulgaria, 2000
        • AIPSOMCIDEMD - Dr. Lilyana Bodurova-Troharova EOOD
      • Sliven, Bulgaria, 8800
        • MHAT Dr. Ivan Seliminski - Sliven AD
      • Smolyan, Bulgaria, 4700
        • Nader Yabrudi - ASMPVBE Individual practice
      • Sofia, Bulgaria, 1606
        • Medical Institute of Ministry of interior
      • Sofia, Bulgaria, 1404
        • MHAT Sveta Sofia EOOD
      • Sofia, Bulgaria, 1527
        • MC Orthopaedic Center Kinov EOOD
      • Sofia, Bulgaria, 1233
        • MHAT Knyaginya Klementina - Sofia EAD
      • Sofia, Bulgaria, 1680
        • Medical centre Vitclinic EOOD
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic UMHAT Tokuda EAD, Endocrinology
      • Sofia, Bulgaria, 1431
        • UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases
      • Sofia, Bulgaria, 1431
        • UMHAT Sveti Ivan Rilski EAD, Nephrology
      • Sofia, Bulgaria, 1618
        • MC Diamedical - 2013 OOD, Sofia
      • Stara Zagora, Bulgaria, 6000
        • MBAL Trakia EOOD
      • Stara Zagora, Bulgaria, 6000
        • Medical Center Zara-Med EOOD
      • Stara Zagora, Bulgaria, 6000
        • Prevencia - 2000 - MCOC OOD
      • Stara Zagora, Bulgaria, 6001
        • Medical Center Nov Rehabilitatsionen center EOOD
      • Stara Zagora, Bulgaria, 6003
        • UMHAT Prof. Dr. Stoyan Kirkovich AD
      • Varna, Bulgaria, 9010
        • UMHAT Sveta Marina EAD
      • Varna, Bulgaria, 9010
        • UMHAT Sveta Marina EAD, Clinic of Internal Diseases
      • Velingrad, Bulgaria, 4600
        • DCC 1 Velingrad EOOD
      • Yambol, Bulgaria, 8600
        • Medical centre Runkovi OOD
      • Yambol, Bulgaria, 8600
        • MHAT Sveti Panteleimon - Yambol AD
    • Kyustendil
      • Dupnitsa, Kyustendil, Bulgaria, 2600
        • Medical centre Asclepius OOD
      • Québec, Canada, G1V 4T3
        • Diex Recherche Quebec
      • Québec, Canada, G1V 4G5
        • Institut universitaire de cardiologie
      • Québec, Canada, G1G 5X1
        • Recherche Clinique Sigma Inc.
    • Alberta
      • Calgary, Alberta, Canada, T2V 4J2
        • C-endo Diab Endo Clin Calgery
      • Calgary, Alberta, Canada, T2H 2G4
        • Centricity Research Calgary
      • Calgary, Alberta, Canada, T2H 2G4
        • Centricity Research Calgary Endocrinology
      • Calgary, Alberta, Canada, T2V 4J2
        • C-Health Partners
    • 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
      • Barrie, Ontario, Canada, L4N 7L3
        • Centricity Res. Barrie Endo
      • Brampton, Ontario, Canada, L6S 0C6
        • Centricity Research Brampton Endocrinology
      • Cambridge, Ontario, Canada, N1R 6V6
        • Cambridge Cardiac Care Centre
      • Hamilton, Ontario, Canada, L8M 1K7
        • Premier Clinical Trial Research Network (PCTRN)
      • Hamilton, Ontario, Canada, L8L 5G8
        • Wharton Medical Clinic Clinical Trials (Hamilton)
      • Toronto, Ontario, Canada, M6G 1M2
        • Diabetes Heart Research Centre
      • Waterloo, Ontario, Canada, N2T 0C1
        • Clinical Research Solutions Inc.
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Ctr de recherche Clinique de Laval
      • Mirabel, Quebec, Canada, J7J 2K8
        • Manna Research Mirabel
      • Montreal, Quebec, Canada, H4A 3T2
        • Applied Medical Informatics Research
      • Québec, Quebec, Canada, G1V 4W2
        • Clin des Mal Lipid de Quebec
      • Saint-Lambert, Quebec, Canada, J4P-1S9
        • Viacar Recherche Clinique Inc.
      • Sherbrooke, Quebec, Canada, J1H 5H3
        • CHU-Sherbrooke
      • Terrebonne, Quebec, Canada, J6X 4P7
        • Ctr de Med Metab de Lanaudiere
      • Barranquilla, Colombia, 080020
        • Fundacion del Caribe para la Investigacion Biomedica-BIOS
      • Bogotá, Colombia, 110221
        • CentrodeInvestigaciónenReumatologíayEspecialidadesMédicas
      • Rionegro, Colombia, 054040
        • Somer Sociedad Medica Rionegro S.A. Somer S.A.
    • Antioquia
      • Medellín, Antioquia, Colombia, 05001
        • Servicios de Salud Ips Suramericana S.A.S.
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 80020
        • Clinica de la Costa
    • Barranquilla
      • Soledad, Barranquilla, Colombia, 83001
        • Fundación Hospital Universidad del Norte
    • Santander Department
      • Bucaramanga-piedecuesta, Valle Del Menzuli - Santander, Santander Department, Colombia, 681012
        • Unidad de Estudios Clínicos de la Fundación Cardiovascular de Colombia
      • Floridablanca, Santander Department, Colombia, 681004
        • FOSCAL
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital, Steno Diabetes Center Aarhus
      • Herning, Denmark, 7400
        • Regionshospitalet Gødstrup, Hjertesygdomme
      • Hillerød, Denmark, 3400
        • Hillerød Endokrinologisk amb. H0652
      • Kolding, Denmark, 6000
        • Kolding Sygehus Karkirurgi
      • Slagelse, Denmark, 4200
        • Slagelse Sygehus Ambulatorium for hjertesygdomme
      • Viborg, Denmark, 8800
        • Viborg Sygehus
    • Capital Region
      • Herlev, Capital Region, Denmark, 2730
        • Herlev Hospital - Afdeling for Hjertesygdomme, Forskning 1
    • Central Jutland
      • Aarhus N, Central Jutland, Denmark, 8200
        • Aarhus Universitetshospital, Hjertesygdomme
    • Region Sjælland
      • Holbæk, Region Sjælland, Denmark, 4300
        • Holbæk Sygehus - Forskningsenheden, Medicinsk Afdeling, afs. 44-4
    • Region South
      • Svendborg, Region South, Denmark, 5700
        • Svendborg Sygehus - Kardiologisk
      • Annonay, France, 07100
        • Centre Hospitalier d'Annonay
      • Annonay, France, 07103
        • Centre Hospitalier Ardeche Nord
      • Bobigny, France, 93000
        • Ap-Hp-Hopital Avicenne
      • Grenoble, France, 38043
        • Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-2
      • Le Coudray, France, 28630
        • Les Hopitaux de Chartres-Hopital Louis Pasteur
      • Le Coudray, France, 28630
        • CH Louis Pasteur
      • Le Havre, France, 76600
        • Groupe Hospitalier du Havre
      • Lille, France, 59000
        • Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez
      • Montpellier, France, 34090
        • Centre Hospitalier Universitaire de Montpellier-Hopital Lapeyronie
      • Paris, France, 75013
        • Aphp-Hopital La Pitie Salpetriere-2
      • Pontoise, France, 95300
        • Hôpital NOVO
      • Vannes, France, 56000
        • Centre hospitalier Bretagne Atlantique
      • Villeurbanne, France, 69100
        • RESEAU DE SANTE MUTUALISTE-Médipôle Hôpital Mutualiste
      • Vénissieux, France, 69200
        • Centre de Recherche Clinique Portes Du Sud
      • Dortmund, Germany, 44137
        • Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
      • Dresden, Germany, 01307
        • Uniklinik TU Dresden - Med. Klinik III
      • Elsterwerda, Germany, 04910
        • Zentrum für klinische Studien Südbrandenburg GmbH
      • Essen, Germany, 45136
        • InnoDiab Forschung GmbH
      • Frankfurt, Germany, 60389
        • MVZ CCB Frankfurt und Main-Taunus GbR
      • Hamburg, Germany, 21109
        • Diabetes-Zentrum Wilhelmsburg
      • Hamburg, Germany, 21109
        • Diabetes-Zentrum-Wilhelmsburg GbR
      • Hamburg, Germany, 22607
        • Wendisch - Dahl Hamburg - DZHW
      • Heidelberg, Germany, 69120
        • Uniklinik Heidelberg - Innere Medizin I
      • Leipzig, Germany, 04107
        • AmBeNet GmbH
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig - Klinik und Poliklinik für Kardiologie
      • Ludwigsburg, Germany, 71634
        • Diabeteszentrum Ludwigsburg
      • Münster, Germany, 48145
        • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
      • Münster, Germany, 48149
        • Uniklinik Münster, Klinik für Kardiologie I
      • Münster, Germany, 48149
        • Universitätsklinikum Münster - Klinik für Kardiologie I
      • Oldenburg in Holstein, Germany, 23758
        • RED-Institut für medizinische Forschung und Fortbildung GmbH
      • Saint Ingbert-Oberwürzbach, Germany, 66386
        • Zentrum für klinische Studien Alexander Segner
      • Wermsdorf, Germany, 04779
        • Al-Zoebi
      • Witten, Germany, 58455
        • Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann
      • Aligarh, India, 202002
        • J N Medical College
      • Bangalore, India, 560 099
        • Narayana Hrudayalya Institute of Cardiac Sciences
      • Gutkar, India, 175021
        • Himachal Heart Institute
      • Jodhpur, India, 342005
        • All India Institute of Medical Sciences (AIIMS)
      • Karad, India, 415539
        • Krishna Institute of Medical Sciences
      • Nagpur, India, 440010
        • Diabetes Care N' Research Centre Pvt. Ltd.
      • Nagpur, India, 440019
        • Hrudaya Cardiac and Vascular Care Centre
      • Nashik, India, 422005
        • Magnum Heart Institute
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, India, 110005
        • Dr. BL Kapur Memorial Hospital
      • New Delhi, India, 110002
        • G.B Pant Institute of Post Graduate medical education and research
      • New Delhi, India, 110005
        • BL Kapur Super Specialty Hospital
      • Pune, India, 411028.
        • WMF's Villoo Poonawalla Memorial Hospital
      • Pune, India, 411001
        • B J Medical College & Sassoon Hospital
      • Telangana, India, 500034
        • Citi neuro centre
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, 522001
        • Endolife Specialty Hospitals
      • Guntur, Andhra Pradesh, India, 522001
        • Lalitha Super Specialities Hospital
      • Guntur, Andhra Pradesh, India, 522001
        • Lalitha PVS Institute of Medical Sciences
      • Hyderabad, Andhra Pradesh, India, 500072
        • Ramdev Rao Hospital
      • Vijayawada, Andhra Pradesh, India, 520002
        • Sunrise Hospital
    • Assam
      • Guwahati, Assam, India, 781033
        • Excelcare Hospital
    • Chhattisgarh
      • Raipur, Chhattisgarh, India, 492007
        • SMC Heart Institute and IVF Research Centre
      • Raipur, Chhattisgarh, India, 390001
        • SMC Heart Institute and IVF Research Centre
    • Gujarat
      • Ahmedabad, Gujarat, India, 380060
        • CIMS- Care Institute of Medical Sciences
      • Ahmedabad, Gujarat, India, 380060
        • Marengo Asia Health Care Private Limited
      • Surat, Gujarat, India, 395002
        • Nirmal Hospital Pvt. Ltd.
      • Surat, Gujarat, India, 395001
        • Unicare heart institute and research centre
      • Vadodara, Gujarat, India, 390022
        • Rhythm Heart Institute
      • Vadodara, Gujarat, India, 390015
        • Bankers Heart Institute
      • Vadodara, Gujarat, India, 390001
        • SSG Hospital, Baroda
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • Ramaiah Memorial Hospital
      • Bangalore, Karnataka, India, 560092
        • Lifecare Hospital and Research Centre
      • Bangalore, Karnataka, India, 560099
        • Narayana Hrudayalya Institute of Cardiac Sciences
      • Mangalore, Karnataka, India, 575002
        • Omega Hospital (P) Limited
      • Mysore, Karnataka, India, 570001
        • Mysore Medical College and Research Institute
    • Kerala
      • Kozhikode, Kerala, India, 673008
        • Government Medical College, Kozhikode
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452007
        • Mohak Bariatrics and Robotics
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431010
        • Kamalnayan Bajaj Hospital
      • Aurangabad, Maharashtra, India, 431005
        • Kamalnayan Bajaj Hospital
      • Karad, Maharashtra, India, 415539
        • Krishna Institute of Medical Sciences
      • Kolhāpur, Maharashtra, India, 416008
        • Excel Endocrine Centre
      • Mumbai, Maharashtra, India, 400012
        • Seth GS Medical College & KEM Hospital
      • Mumbai, Maharashtra, India, 400004
        • Sir H. N. Reliance Foundation Hospital and Research Centre
      • Mumbai, Maharashtra, India, 400011
        • Wockhardt Hospital, Mumbai Central
      • Nagpur, Maharashtra, India, 441108
        • All India Institute of Medical Sciences (AIIMS), Nagpur
      • Nagpur, Maharashtra, India, 440033
        • Sengupta Hospital and Research Institute
      • Nagpur, Maharashtra, India, 441110
        • Shalini Tai Meghe Hospital and Research Center
      • Nagpur, Maharashtra, India, 440019
        • Hrudaya Cardiac and Vascular Care Centre
      • Nashik, Maharashtra, India, 422005
        • Magnum Heart Institute
      • Pune, Maharashtra, India, 411001
        • Grant Medical foundation Ruby Hall Clinic
      • Pune, Maharashtra, India, 411021
        • Chellaram Diabetes Institute
      • Thane, Maharashtra, India, 421004
        • Ashirwad Hospital and Research Centre
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110002
        • G B Pant Institute of Postgraduate Medical Education and Research
    • New Delhi
      • Ansārinagar, New Delhi, India, 110029
        • All India Institute of Medical Sciences_Delhi
      • Delhi, New Delhi, India, 110076
        • Apollo Hospital
    • Odisha
      • Bhubaneswar, Odisha, India, 751030
        • AMRI Hospital
      • Khurda, Odisha, India, 751019
        • All India Institute of Medical Sciences_Khurda
    • Punjab
      • Ludhiana, Punjab, India, 141008
        • Christian Medical College and Hospital
      • Mohali, Punjab, India, 160062
        • Fortis Heart Institute and Multispeciality Hospital
    • Rajasthan
      • Ajmer, Rajasthan, India, 305001
        • Jawahar Lal Nehru Govt. Medical College
      • Bikaner, Rajasthan, India, 334003
        • SP Medical College
      • Jaipur, Rajasthan, India, 302004
        • SMS Medical College & Attached Hospitals
      • Jaipur, Rajasthan, India, 302006
        • Diabetes, Thyroid and Endocrine Centre
      • Jodhpur, Rajasthan, India, 342005
        • All India Institute of Medical Sciences (AIIMS)
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Madras Diabetes Research Foundation
      • Coimbatore, Tamil Nadu, India, 641018
        • Kg Hospital and Post Graduate Medical Institute
      • Vellore, Tamil Nadu, India, 632004
        • Christian Medical College Hospital, Vellore
    • Telangana
      • Hyderabad, Telangana, India, 500020
        • Guru Nanak CARE Hospitals
      • Hyderabad, Telangana, India, 500032
        • AIG Hospitals,Hyderabad
      • Hyderabad, Telangana, India, 500082
        • Diabetes Research Center, Hyderabad
      • Hyderabad, Telangana, India, 500084
        • Yashoda Hospital
    • Uttar Pradesh
      • Aligarh, Uttar Pradesh, India, 202002
        • J N Medical College
      • Lucknow, Uttar Pradesh, India, 226014
        • Sanjay Gandhi Postgraduate Institute of Medical Sciences
      • Lucknow, Uttar Pradesh, India, 226014
        • Sanjay Gandhi Postgraduate Institute of Medical Science
      • Lucknow, Uttar Pradesh, India, 226003
        • King George's Medical University (KGMU)
    • Uttarakhand
      • Dehradun, Uttarakhand, India, 248001
        • Shri Mahant Indiresh Hospital
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • IPGME&R and SSKM Hospital
      • Kolkata, West Bengal, India, 700054
        • Apollo Multispeciality Hospital, Kolkata
    • Connaght
      • Galway, Connaght, Ireland, H91 YR71
        • CRF - Galway
      • Galway, Connaght, Ireland, H91 YR71
        • CRF HRB - Galway
    • Leinster
      • Dublin, Leinster, Ireland, D04 T6F4
        • Clinical Research Centre, St. Vincent's University Hospital,
      • Dublin, Leinster, Ireland, D07 XAO9
        • Mater Miscericordiae Hospital
      • Dublin, Leinster, Ireland, D08 A978
        • St James's CRF
      • Dublin, Leinster, Ireland, DUBLIN 7
        • Mater Miscericordiae Hospital
      • Dublin, Leinster, Ireland, D15 X40D
        • Connolly Hospital_Blanchardstown_Diabetes Day Centre
      • Acquaviva delle Fonti, Italy, 70021
        • Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC
      • Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
      • Bologna, Italy, 40138
        • A.O.U. Policlinico S.Orsola Malpighi
      • Bologna, Italy, 40138
        • A.O.U. Bologna_ Policlinico S.Orsola Malpighi
      • Catania, Italy, 95123
        • A.O.U policlinico "G. Rodolico-San Marco"
      • Milan, Italy, 20157
        • Azienda Ospedaliera Luigi Sacco
      • Modena, Italy, 41126
        • Azienda Ospedaliero Universitaria di Modena Ospedale Civile di Baggiovara
      • Naples, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II Di Napoli
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Roma, Italy, 00189
        • Azienda ospedaliero - universitaria Sant'Andrea
      • Roma, Italy, 00128
        • Pol. Uni. Campus Biomedico UOC Endocrinologia e Diabetologia
      • Sesto San Giovanni (MI), Italy, 20099
        • IRCCS MultiMedica
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66100
        • Università degli studi G. D'Annunzio Chieti Pescara - CAST
    • BA
      • Bari, BA, Italy, 70124
        • A.O.U. Consorziale Policlinico di Bari
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41126
        • Azienda Ospedaliero Universitaria Di Modena
      • Parma, Emilia-Romagna, Italy, 43126
        • Azienda Ospedaliera-Universitaria Parma
    • LT
      • Latina, LT, Italy, 04100
        • Ospedale Santa Maria Goretti - UOD Diabetologia
    • Lazio
      • Rome, Lazio, Italy, 00128
        • Pol. Uni. Campus Biomedico - UOC Endocrinologia e Diabetologia
    • Lombardy
      • San Donato Milanese (MI), Lombardy, Italy, 20097
        • Policlinico San Donato S.p.A.
    • Mi
      • San Donato Milanese (MI), Mi, Italy, 20097
        • Centro di Alta Spec. Diet., Educ. Alim. e Prev. Cardio Metab
    • Pv
      • Pavia, Pv, Italy, 27100
        • ICS Maugeri
    • RM
      • Rome, RM, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCS
    • Si
      • Siena, Si, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese
    • Sicily
      • Palermo, Sicily, Italy, 90127
        • AOUP Giaccone Palermo
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • AOU Careggi Firenze
    • VE
      • Mirano, VE, Italy, 30035
        • Azienda Ulss 3 Serenissima
      • Chiba-shi, Chiba, Japan, 260-0804
        • Akaicho Clinic
      • Ehime, Japan, 790-0034
        • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism_Diabetes Internal Medicine
      • Ibaraki, Japan, 311-0113
        • Naka Kinen Clinic_Internal medicine
      • Minato-ku, Tokyo, Japan, 108-0073
        • Tokyo Saiseikai Central Hospital
      • Mito-shi, Ibaraki, Japan, 311-4153
        • Minami Akatsuka Clinic
      • Okinawa, Japan, 901-0493
        • Nanbu Tokushukai Hospital_Internal medicine
      • Osaka, Japan, 581-0011
        • Yao Tokushukai General Hospital
      • Osaka, Japan, 574-0074
        • Nozaki Tokushukai Hospital_Internal medicine
      • Osaka, Japan, 581-0011
        • Yao Tokushukai General Hospital_Cardiovascular division
      • Osaka, Japan, 530-0001
        • Osaka NISHI-UMEDA Clinic_Internal Medicine
      • Osaka-city, Osaka, Japan, 530-0005
        • Sakurabashi Watanabe Advanced Healthcare Hospital
      • Saga, Japan, 849-8501
        • Saga University Hospital, Department of Cardiology
      • Takamatsu-shi, Kagawa, Japan, 760-8557
        • Kagawa Prefectural Central Hospital_Cardiovascular Medicine
      • Takasaki-shi, Gunma, Japan, 370-0829
        • Takasaki General Medical Center_Department of Endocrinology / Metabolism Internal Medicine
      • Tokyo, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
      • Tokyo, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic_Internal Medicine
      • Tokyo, Japan, 104-0031
        • Fukuwa Clinic_Internal Medicine
      • Wakayama, Japan, 640-8558
        • Japanese Red Cross Wakayama Medical Center_Diabetology and Endocrinology
      • Wako-shi, Saitama, Japan, 351-0102
        • National Hospital Organization Saitama Hospital_Cardiology
    • Fukushima, Japan
      • Koriyama-shi, Fukushima, Japan, Japan, 963-8851
        • Seino Internal Medicine Clinic
      • Koriyama-shi, Fukushima, Fukushima, Japan, Japan, 963-8851
        • Seino Internal Medicine Clinic_Internal medicine
    • Kumamoto, Japan
      • Kumamoto, Kumamoto, Japan, Japan, 862-0976
        • Jinnouchi Hospital_Internal Medicine
      • Malacca, Malaysia, 75400
        • Hospital Melaka
      • Putrajaya, Malaysia, 62250
        • Hospital Putrajaya
      • Sarawak, Malaysia, 98000
        • Hospital Miri
      • Selangor Darul Ehsan, Malaysia, 68000
        • Hospital Ampang
      • Shah Alam, Malaysia, 40000
        • Hospital Shah Alam
      • Wilayah Persekutuan Putrajaya, Malaysia, 62250
        • Hospital Putrajaya
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Hospital Tengku Ampuan Afzan
      • Temerluh, Pahang, Malaysia, 28000
        • Hospital Sultan Haji Ahmad Shah
    • Perak
      • Seri Manjung, Perak, Malaysia, 32040
        • Hospital Seri Manjung
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10450
        • Hospital Pulau Pinang
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Sarawak General Hospital
      • Miri, Sarawak, Malaysia, 98000
        • Hospital Miri
      • Sibu, Sarawak, Malaysia, 96000
        • Hospital Sibu
    • Selangor
      • Ampang, Selangor, Malaysia, 68000
        • Hospital Ampang
      • Kajang, Selangor, Malaysia, 43000
        • Hospital Serdang
      • Aguascalientes, Mexico, 20230
        • Promotora Medica Aguascalientes SA de CV
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Virgen Cardiovascular Research SC
      • Guadalajara, Jalisco, Mexico, 44670
        • Centro de Investigacion Clinica Endocrinologica de Jalisco
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Instituto de Diabetes Obesidad y Nutricion S.C.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Unidad Biomédica Avanzada Monterrey
      • Monterrey, Nuevo León, Mexico, 64060
        • Cardiolink Clin Trials S.C.
      • Monterrey, Nuevo León, Mexico, 64020
        • Internal Medicine Clin Trials
      • Monterrey, Nuevo León, Mexico, 64610
        • Clínica García Flores
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexico, 78200
        • Centro de Atención e Investigación Cardiovascular del Potosí
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80230
        • Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada, S.C.
      • Culiacán, Sinaloa, Mexico, 80230
        • Centro para el Desarrollo de la Medicina y la Asistencia
    • Tamaulipas
      • Ciudad Madero, Tamaulipas, Mexico, 89440
        • Centro de Estudios de Investigación Metabólicos y Cardio
    • Veracruz
      • Xalapa, Veracruz, Mexico, 91193
        • Consultorio 1020 Hospital Angeles Xalapa
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre Zkh Apeldoorn
      • Eindhoven, Netherlands, 5631 BM
        • Maxima MC Eindhoven
      • Gouda, Netherlands, 2803HH
        • Groene Hart Zkh Gouda
      • Groningen, Netherlands, 9713 GZ
        • UMC Groningen
      • Leeuwarden, Netherlands, 8934 AD
        • Frisius MC Leeuwarden
      • Nijmegen, Netherlands, 6525 GA
        • Radboudumc
      • Rotterdam, Netherlands, 3045 PM
        • Franciscus Gasthuis en Vlietland
      • Sneek, Netherlands, 8601 ZR
        • D & A Research B.V.
      • Tiel, Netherlands, 4002 WP
        • Zkh Rivierenland Tiel - Cardiologie
      • Bialystok, Poland, 15-351
        • Osteo-Medic s.c. A. Racewicz, J. Supronik
      • Bialystok, Poland, 15-797
        • Renew Clinic Sp. z o.o.
      • Bielsko-Biala, Poland, 43-316
        • American Heart of Poland S.A.
      • Bydgoszcz, Poland, 85-231
        • Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
      • Chojnice, Poland, 89-600
        • Pratia S.A.
      • Dąbrówka, Poland, 62-069
        • NSZOZ Unica CR
      • Elblag, Poland, 82-300
        • Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
      • Gdansk, Poland, 80-214
        • UCK Klinika Nadcisnienia Tetniczego i Diabetologii
      • Gorzów Wielkopolski, Poland, 66-400
        • Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
      • Katowice, Poland, 40-752
        • Uniwersyteckie Centrum Kliniczne SUM w Katowicach
      • Katowice, Poland, 40-568
        • Care Clinic Sp. z o. o.
      • Krakow, Poland, 30-033
        • Grazyna Pulka Specjalistyczny Osrodek "All-Med"
      • Lodz, Poland, 90-132
        • Gabinet Lekarski Malgorzata Saryusz-Wolska
      • Lodz, Poland, 92-213
        • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
      • Lublin, Poland, 20-601
        • Zanamed Medical Clinic Sp. z o.o.
      • Piotrkow Trybunalski, Poland, 97-300
        • Provita Centrum Medyczne Sp. z o.o.
      • Poznan, Poland, 61-251
        • Maciej Wiza Gaja Poradnie Lekarskie
      • Tychy, Poland, 43-100
        • Polsko - Amerykanskie Kliniki Serca X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji w Tychach
      • Warsaw, Poland, 03-712
        • Bodyclinic
      • Warsaw, Poland, 00-739
        • Szpital Czerniakowski Sp. z o.o.
      • Warsaw, Poland, 03-984
        • NASMED
      • Wroclaw, Poland, 53-034
        • Pracownia Badan Klinicznych Salus
      • Zabrze, Poland, 41-800
        • Wojewodzka Poradnia dla Chorych na Cukrzyce w Zabrzu
      • Zamość, Poland, 22-400
        • Velocity Nova Sp. z o.o. Velocity Zamosc
      • Łask, Poland, 98-100
        • Szpitale Powiatowe Sp. z o.o.
    • Gornoslaskie
      • Ruda Śląska, Gornoslaskie, Poland, 41-709
        • Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
    • Greater Poland Voivodeship
      • Dąbrówka, Greater Poland Voivodeship, Poland, 62-069
        • NSZOZ Unica CR
    • Kuyavian-Pomeranian Voivodeship
      • Bygdoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Gierach-Med
    • Lesser Poland Voivodeship
      • Chrzanów, Lesser Poland Voivodeship, Poland, 32-500
        • Malopolskie Centrum Sercowo-Naczyniowe
      • Krakow, Lesser Poland Voivodeship, Poland, 31-261
        • Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
    • Lower Silesian Province
      • Wroclaw, Lower Silesian Province, Poland, 50-127
        • Regionalna Poradnia Diabetologiczna-Zytkiewicz-Jaruga, Stasinska Spolka Partnerska Lekarzy
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-981
        • 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-114
        • 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-362
        • Velocity Nova Sp. z o.o.
      • Poniatowa, Lublin Voivodeship, Poland, 24-320
        • ETG Poniatowa
    • Lubusz Voivodeship
      • Gorzów Wielkopolski, Lubusz Voivodeship, Poland, 66-400
        • Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
    • Masovian Province
      • Warsaw, Masovian Province, Poland, 02-647
        • Provita Poliklinika sp. z o.o
      • Warsaw, Masovian Province, Poland, 02-786
        • MEDI CLINICAL Badania Kliniczne
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-416
        • Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orłowskiego Centrum Medycznego Kształcenia Podyplomowego
      • Warsaw, Masovian Voivodeship, Poland, 02-677
        • ETG Warszawa Sp. z o.o.
      • Warsaw, Masovian Voivodeship, Poland, 00-416
        • Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego Centrum Medycznego Ksztalcenia Podyplomowego
      • Żyrardów, Masovian Voivodeship, Poland, 96-300
        • Prywatna Praktyka Lekarska Anna Chudoba
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-281
        • Gabinet Leczenia Otylosci i Chorob Dietozaleznych
      • Bialystok, Podlaskie Voivodeship, Poland, 15-481
        • Kresmed Sp. z o. o.
      • Bialystok, Podlaskie Voivodeship, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia
    • Silesian Voivodeship
      • Chorzów, Silesian Voivodeship, Poland, 41-500
        • M2M Med. Badania Sp. z o.o.
      • Katowice, Silesian Voivodeship, Poland, 40-648
        • Pro Familia Altera Sp. z o.o.
      • Katowice, Silesian Voivodeship, Poland, 40-555
        • Kardio Klinika Brynow
      • Zabrze, Silesian Voivodeship, Poland, 41-800
        • Slaskie Centrum Chorob Serca W Zabrzu
      • Zabrze, Silesian Voivodeship, Poland, 41-800
        • Wojewodzka Poradnia dla Chorych na Cukrzyce w Zabrzu
    • Wielkopolskie Voivodeship
      • Poznan, Wielkopolskie Voivodeship, Poland, 60-589
        • Centrum Zdrowia Metabolicznego
      • Poznan, Wielkopolskie Voivodeship, Poland, 60-589
        • Centrum Zdrowia Metabolicznego Paweł Bogdański
    • Łódź Voivodeship
      • Bełchatów, Łódź Voivodeship, Poland, 97-400
        • American Heart of Poland S.A.
      • Lodz, Łódź Voivodeship, Poland, 93-513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
    • Świętokrzyskie Voivodeship
      • Staszów, Świętokrzyskie Voivodeship, Poland, 28-200
        • Velocity Nova Sp. z o.o.
      • Guaynabo, Puerto Rico, 00968
        • Isis Clinical Res. Ctr P.S.C.
      • Belgrade, Serbia, 11000
        • Military Medical Academy
      • Belgrade, Serbia, 11080
        • Clinical Hospital Center Bezanijska Kosa
      • Belgrade, Serbia, 11000
        • Endocrinology, Diabetes and Metabolism Diseases Clinic
      • Belgrade, Serbia, 11000
        • CHC Zvezdara, Clinical department for endocrinology
      • Kragujevac, Serbia, 34000
        • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
      • Zaječar, Serbia, 19000
        • Policlinic for diabetes
    • RS
      • Niš, RS, Serbia, 18 000
        • University Clinical Centre Nis
      • Niš, RS, Serbia, 18000
        • Clinical Centre Nis, Endocrinology, Diabetes and Metabolism
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6001
        • Phoenix Pharma
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1827
        • Hemant Makan
      • Johannesburg, Gauteng, South Africa, 2013
        • Wits Bara Clinical Trial Site
      • Johannesburg, Gauteng, South Africa, 1818
        • Soweto Clinical Trial Centre
      • Johannesburg, Gauteng, South Africa, 2193
        • Ezintsha Research Centre
      • Pretoria, Gauteng, South Africa, 0183
        • Jongaie Research
      • Pretoria, Gauteng, South Africa, 0186
        • Clinical Trial Systems (CTC)
      • Pretoria, Gauteng, South Africa, 0083
        • Dr Seeber
      • Pretoria, Gauteng, South Africa, 0181
        • Prof P. Joshi
      • Pretoria, Gauteng, South Africa, 0002
        • Prinshof Medical Campus
      • Pretoria, Gauteng, South Africa, 0157
        • Dr IO Ebrahim Inc
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4450
        • Dr Pillay's Rooms
      • Durban, KwaZulu-Natal, South Africa, 4092
        • Dr A Amod
      • Durban, KwaZulu-Natal, South Africa, 4320
        • Netcare Umhlanga Medical Centre
      • Durban, KwaZulu-Natal, South Africa, 4901
        • Lenmed Shifa Private Hospital
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7500
        • Tread Research (Pty)Ltd
      • Cape Town, Western Cape, South Africa, 7925
        • Prof Rayner_Division of Nephrology
      • Cape Town, Western Cape, South Africa, 7935
        • Cardiac Clinical Research Unit, University of Cape Town
      • Mossel Bay, Western Cape, South Africa, 6500
        • Dr Hendrik Snyman's Practice
      • Worcester, Western Cape, South Africa, 6850
        • Clinical Projects Research
      • Antequera, Spain, 29200
        • Hosp. Comarcal de Antequera_Medicina Interna
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Castilleja de la Cuesta, Spain, 41950
        • Hospital Vithas Sevilla
      • Córdoba, Spain, 14004
        • Hospital Reina Sofia
      • Las Palmas de Gran Canaria, Spain, 35010
        • Hospital Univ. de Gran Canaria Doctor Negrín
      • Madrid, Spain, 28009
        • Hospital Gregorio Marañón
      • Málaga, Spain, 29010
        • Hospital Clínico Virgen de la Victoria
      • Málaga, Spain, 29010
        • H. Clinico Univ. Virgen de la Victoria
      • Palma de Mallorca, Spain, 07120
        • Hospital Son Espases
      • Pozuelo de Alarcón, Spain, 28223
        • Hospital Quirón
      • Pozuelo de Alarcón, Spain, 28223
        • H.U. Quirónsalud Madrid
      • Sanlúcar de Barrameda, Spain, 11540
        • H Virgen del Camino_Sanlúcar_Medicina Interna
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Seville, Spain, 41003
        • Clínica Nuevas Tecnologías en Diabetes y Endocrinología
      • Toledo, Spain, 45007
        • Hospital General Universitario de Toledo
      • Valencia, Spain, 46014
        • Hospital General de Valencia
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
    • Valencia
      • Alzira, Valencia, Spain, 46600
        • H.de La Ribera_Endocrinología
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi hospital
      • Bangkok, Thailand, 10300
        • Vajira Hospital - Cardio
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital_Diabetes and Endocrinology
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital_Neurology
      • Chiang Mai, Thailand, 50200
        • RIHES-CMU_Research Institute for Health Sciences
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai
      • Chiang Rai, Thailand, 57000
        • Chiang Rai Prachanukroh Hospital
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital
      • Nakhon Ratchasima, Thailand, 30000
        • Maharat Nakhon Ratchasima Hospital
      • Pathum Thani, Thailand, 12120
        • Thammasat Hospital_Cardiology
    • Bangkok Noi
      • Bangkok, Bangkok Noi, Thailand, 10700
        • Siriraj Hospital
    • Had-Yai
      • Songkhla, Had-Yai, Thailand, 90110
        • Songklanagarind Hospital
      • Adana, Turkey (Türkiye), 01000
        • T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
      • Adana, Turkey (Türkiye), 01250
        • Baskent Universitesi Adana
      • Adana, Turkey (Türkiye), 01250
        • Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi
      • Afyonkarahisar, Turkey (Türkiye), 03200
        • Afyonkarahisar Health Sciences University
      • Afyonkarahisar, Turkey (Türkiye), 03200
        • Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji
      • Ankara, Turkey (Türkiye), 06800
        • Ankara Sehir Hastanesi Dahiliye Klinigi
      • Ankara, Turkey (Türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi-Dahiliye
      • Edirne, Turkey (Türkiye), 22030
        • Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji
      • Eskişehir, Turkey (Türkiye), 26080
        • Eskişehir Şehir Hastanesi- Kardiyoloji
      • Istanbul, Turkey (Türkiye), 34303
        • Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi
      • Istanbul, Turkey (Türkiye), 34371
        • Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi
      • Istanbul, Turkey (Türkiye), 34480
        • Başakşehir Çam ve Sakura Şehir Hastanesi
      • Istanbul, Turkey (Türkiye), 34371
        • Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi- Seyrantepe Yerleşkesi- Endokrinoloji
      • Istanbul, Turkey (Türkiye), 34722
        • Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
      • Istanbul, Turkey (Türkiye), 34098
        • İstanbul Üniversitesi-Cerrahpaşa Kardiyoloji Enstitüsü
      • Izmir, Turkey (Türkiye), 35340
        • Dokuz Eylül Üniversitesi Araştırma Uygulama Hastanesi-Endokrinoloji
      • Kahramanmaraş, Turkey (Türkiye), 46040
        • Kahramanmaras Sutcu Imam University
      • Kayseri, Turkey (Türkiye), 38039
        • Erciyes Universitesi Tip Fakultesi
      • Kayseri, Turkey (Türkiye), 38039
        • Erciyes Üniversitesi Hastanesi- Kardiyoloji
      • Kayseri, Turkey (Türkiye), 38039
        • Erciyes Üniversitesi Hastanesi- Endokrinoloji
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli Universitesi Tip Fakultesi Hastanesi
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli Üniversitesi Hastanesi- Kardiyoloji
      • Kütahya, Turkey (Türkiye), 43040
        • Kütahya Sağlık Bilimleri Üniversitesi Evliya Çelebi EAH- Kardiyoloji
      • Mersin, Turkey (Türkiye), 33343
        • Mersin University Cardiology
      • Mersin, Turkey (Türkiye), 33070
        • Mersin Üniversitesi Tip Fakültesi Hastanesi- Endokrinoloji
      • Mersin, Turkey (Türkiye), 33343
        • Mersin Üniversitesi Hastanesi- Kardiyoloji
      • Pendik/istanbul, Turkey (Türkiye), 34899
        • Marmara Üniversitesi Pendik EAH- Endokrinoloji
      • Samsun, Turkey (Türkiye), 55200
        • Ondokuz Mayıs Üniversitesi Hastanesi- Kardiyoloji
      • Yüreğir/Adana, Turkey (Türkiye), 1370
        • Adana Şehir Eğitim ve Araştırma Hastanesi-Endokrinoloji
    • Bahcelievler
      • Ankara, Bahcelievler, Turkey (Türkiye), 06490
        • Baskent University Ankara Hospital
      • Ankara, Bahcelievler, Turkey (Türkiye), 06490
        • Başkent Üniversitesi Ankara Hastanesi-Endokrinoloji
    • Kartal
      • Istanbul, Kartal, Turkey (Türkiye), 34844
        • Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi
    • Odunpazari
      • Eskişehir, Odunpazari, Turkey (Türkiye), 26040
        • Eskisehir Osmangazi University Sağlık Uygulama ve Arastirma
      • Eskişehir, Odunpazari, Turkey (Türkiye), 26040
        • Eskişehir Osmangazi Üniversitesi Hastanesi- Kardiyoloji
    • Yildirim
      • Bursa, Yildirim, Turkey (Türkiye), 16110
        • Bursa Yüksek İhtisas Eğitim ve Araştırma Merkezi-Kardiyoloji
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Bradford-on-Avon, United Kingdom, BA15 1DQ
        • The Health Centre
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Chester, United Kingdom, CH2 1UL
        • Countess of Chester Hospital - Diabetes
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry - WISDEM Centre
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Glasgow, United Kingdom, G20 0XA
        • Intelligent Clinical
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary - Diabetes
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital - Diabetes
      • Leeds, United Kingdom, LS9 7TF
        • St James's University Hospital - Diabetes
      • Leicester, United Kingdom, LE5 4PW
        • Leicester General Hospital
      • London, United Kingdom, SW10 0LR
        • The Good Practice
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • NIHR Commercial Research Delivery Centre Newcastle
      • Plymouth, United Kingdom, PL6 5FP
        • Derriford Hospital
      • Redhill, United Kingdom, RH1 5RH
        • East Surrey Hospital
      • Rotherham, United Kingdom, S65 1DA
        • Clifton Medical Centre
      • Soham, United Kingdom, CB7 5JD
        • Staploe Medical Centre
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital (Treliske)
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B9 5SS
        • Heartlands Hospital - Diabetes
    • West Sussex
      • Chichester, West Sussex, United Kingdom, PO19 6SE
        • St. Richard's Hospital_Cardiology
    • Alabama
      • Birmingham, Alabama, United States, 32533
        • Univ of Alabama Birmingham
      • Montgomery, Alabama, United States, 36106
        • Chambliss Clinical Trials LLC
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Honor Health
    • California
      • Beverly Hills, California, United States, 90211
        • National Heart Institute Cal
      • Covina, California, United States, 91723
        • Valley Clinical Trials
      • La Jolla, California, United States, 92037
        • Scripps Wht Diab Inst La Jolla
      • Lancaster, California, United States, 93534
        • First Valley Medical Group
      • Lincoln, California, United States, 95648
        • Clinical Trials Research_Sacramento
      • Lomita, California, United States, 90717
        • Torrance Clin Res Inst, Inc.
      • Los Alamitos, California, United States, 90720
        • Pacific Clinical Studies
      • Monterey, California, United States, 93940
        • Monterey Endocrine & Diabetes Institute, Inc
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • Palm Springs, California, United States, 92262
        • Desert Oasis Hlthcr Med Group
      • Pomona, California, United States, 91766
        • Western University of Health Sciences
      • San Diego, California, United States, 92111
        • Linda Vista Health Care Ctr
      • San Dimas, California, United States, 91773
        • N America Res Inst - San Dimas
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research_Spring Valley
      • Torrance, California, United States, 90502
        • Lundquist Inst.-Biom Inno-UCLA
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
    • Florida
      • Clearwater, Florida, United States, 33756
        • Innovative Research of W FL
      • Delray Beach, Florida, United States, 33445
        • Florida Premier Cardiology
      • Fleming Island, Florida, United States, 32003
        • Fleming Island Center for Clinical Research
      • Miami, Florida, United States, 33144
        • Oceane 7 Medical & Research Center, Inc.
      • Miami, Florida, United States, 33174
        • Reyes Clinical Research, Inc
      • Miami, Florida, United States, 33130
        • Life Spring Research Foundation LLC
      • Miami Lakes, Florida, United States, 33016
        • Floridian Clinical Research, LLC
      • Miami Lakes, Florida, United States, 33014
        • San Marcus Res Clin Miami Lakes
      • Mt. Dora, Florida, United States, 32757
        • Adult Medicine of Lake County, Inc.
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • Pembroke Pines, Florida, United States, 33024
        • Center for Diab,Obes & Metab
      • Port Charlotte, Florida, United States, 33952
        • Hanson Clinical Research Center
      • Saint Augustine, Florida, United States, 32080
        • Northeast Research Institute
      • Wellington, Florida, United States, 33449
        • Cardio Partners Clin Res Inst
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Endo Res Solutions Inc
      • Tucker, Georgia, United States, 30084
        • Atlanta Heart Specialists, LLC
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Rocky Mountain Diab&Osteo Ctr
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Heart Clinical Research, LLC
      • Gillespie, Illinois, United States, 62033
        • Macoupin Research Group
      • Gurnee, Illinois, United States, 60031
        • Clinical Invest Special_Gurnee
      • Skokie, Illinois, United States, 60077
        • Endeavor Health
    • Indiana
      • Franklin, Indiana, United States, 46131
        • American Hlth Ntwk of IN LLC
    • Iowa
      • Council Bluffs, Iowa, United States, 51501
        • West Broadway Clinic
      • West Des Moines, Iowa, United States, 50266
        • Iowa Diab & Endo Res Center
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Midwest Heart & Vasc Spec
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • The Research Group of Lexington LLC
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Louisiana Heart Center
      • Hammond, Louisiana, United States, 70403
        • Louisiana Heart Center
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
      • West Monroe, Louisiana, United States, 71291
        • Clinical Trials of America
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Ascension Saint Agnes Heart Ca
    • Michigan
      • Flint, Michigan, United States, 48532
        • Elite Research Center
      • Troy, Michigan, United States, 48098
        • Arcturus HC PLC Troy Med Res
    • Mississippi
      • Diamondhead, Mississippi, United States, 39525
        • Memorial Hospital at Gulfport
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research LLC
      • Kansas City, Missouri, United States, 64111
        • Clinical Research Consultants, LLC
      • Springfield, Missouri, United States, 65807
        • Clinvest Research
      • St Louis, Missouri, United States, 63128
        • Amicis Centers of Clinical Research
      • St Louis, Missouri, United States, 63136
        • St Louis Heart & Vascular, P.C.
    • Nebraska
      • Omaha, Nebraska, United States, 68198-6828
        • Univ of NE Med Center_Omaha
      • Omaha, Nebraska, United States, 68114
        • Methodist Physicians Clin
      • Omaha, Nebraska, United States, 68105
        • VA Neb West Iowa Hlth System
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Southern New Hampshire Diabetes and Endocrinology
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Renal Medicine Associates
    • New York
      • Albany, New York, United States, 12203
        • Albany Medical College
      • New Windsor, New York, United States, 12553
        • Mid Hudson Med Res-New Windsor
      • New York, New York, United States, 10036
        • IMA Clinical Research- NY
      • Saratoga Springs, New York, United States, 12866
        • Saratoga Clinical Research
      • The Bronx, New York, United States, 10456
        • Prime Global Research Inc.
      • West Seneca, New York, United States, 14224
        • Southgate Medical Group, LLP
      • Westfield, New York, United States, 14787
        • Great Lakes Medical Research
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC- Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Morehead City, North Carolina, United States, 28557
        • Carteret Medical Group
      • New Bern, North Carolina, United States, 28562
        • Eastern Nephrology Associates, PLLC
      • Statesville, North Carolina, United States, 28625
        • Piedmont Healthcare/Research
      • Winston-Salem, North Carolina, United States, 27103
        • Brookview Hills Research Associates, LLC
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research LLC
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic - Main Campus
      • Dayton, Ohio, United States, 45439
        • Providence Health Partners Ctr
      • Maumee, Ohio, United States, 43537
        • Ohio- Advanced Medical Research
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Heritage Valley Medical Group
      • Newport, Pennsylvania, United States, 17074
        • Capital Area Research LLC
      • Philadelphia, Pennsylvania, United States, 19114
        • Aria Endocrine Metabolic Assoc
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Health Specialists
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Univ Diab & Endo Consultants
    • Texas
      • Amarillo, Texas, United States, 79106
        • PharmaTex Research
      • Arlington, Texas, United States, 76012-4637
        • Arlington Family Res. Ctr Inc
      • Corpus Christi, Texas, United States, 78404
        • South Texas Clinical Research
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Res-Dallas
      • Dallas, Texas, United States, 75226
        • Baylor Scott & White Res Inst
      • Duncanville, Texas, United States, 75137
        • Dallas Heart and Vascular
      • El Paso, Texas, United States, 79935
        • Academy of Diabetes, T&E
      • Fort Worth, Texas, United States, 76132
        • Diabetes and Thyroid Ctr of FW
      • Harlingen, Texas, United States, 78550
        • Forefront Med Res Inst PLLC
      • Houston, Texas, United States, 77024
        • PrimeCare Medical Group
      • Houston, Texas, United States, 77099
        • Southwest Houston Research Ltd
      • Houston, Texas, United States, 77061
        • Synergy Groups Medical
      • Katy, Texas, United States, 77493
        • Prem Internal Med Asso Houston
      • Lampasas, Texas, United States, 76550
        • Radiance Clinical Research
      • Longview, Texas, United States, 75605
        • DCOL Ctr for Clin Res
      • Lufkin, Texas, United States, 75904
        • Texas Inst, Kdny & Endo Disor
      • McKinney, Texas, United States, 75071
        • Texas Institute of Cardiology PA
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes & Endocrinology_Round Rock
      • San Antonio, Texas, United States, 78212
        • Clinical Advancement Center
      • San Antonio, Texas, United States, 78229
        • Audie L. Murphy VA Hospital
      • San Antonio, Texas, United States, 78233
        • Northeast Clinical Research of San Antonio
      • San Antonio, Texas, United States, 78220
        • San Antonio Prem Int Med
      • San Antonio, Texas, United States, 78229
        • Bexar County Hospital District
      • Sugar Land, Texas, United States, 77478
        • Simcare Medical Research, LLC
      • Victoria, Texas, United States, 77901
        • Crossroads Clinical Res- Texas
      • Waco, Texas, United States, 76708
        • Hillcrest Family Health Center
      • Weslaco, Texas, United States, 78596
        • Valley Diab. & Endo Comp Ctr
    • Virginia
      • Norfolk, Virginia, United States, 23540
        • York Clinical Research LLC
      • Richmond, Virginia, United States, 23219
        • Dominion Medical Associates
      • Salem, Virginia, United States, 24153-6404
        • VA Medical Center_Salem
      • Winchester, Virginia, United States, 22601-3834
        • Selma Medical Associates
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Confluence Health Hospital
    • Wisconsin
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Research Institute

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

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female
  • Age above or equal to 55 years at the time of signing informed consent
  • Body mass index (BMI) greater than or equal to (>=) 25.0 kilograms per meter square (kg/m^2)
  • Established CVD as evidenced by at least one of the following:

    1. Prior myocardial infarction
    2. Prior stroke (ischemic or haemorrhagic stroke)
    3. Symptomatic peripheral arterial disease (PAD) defined as at least one of the following:

      1. Intermittent claudication with an ankle-brachial index (ABI) less than (<) 0.85 at rest
      2. Intermittent claudication with a >= 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computed tomography (CT) angiography or Doppler ultrasound
      3. Prior revascularization procedure of a lower extremity peripheral artery
      4. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)

For participants with T2D at screening the following inclusion criteria also apply:

  • Diagnosed with type 2 diabetes mellitus (T2D) >= 180 days before screening
  • HbA1c 6.5%-10% (47-86 millimoles per mole [mmol/mol]) (both inclusive), as measured by central laboratory at screening
  • Treatment with either:

    1. Lifestyle intervention alone
    2. 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), dipeptidyl peptidase 4 (DPP4)-inhibitors, thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local label
    3. Basal insulin alone or in combination with up to two marketed OADs, all according to local label

Exclusion Criteria:

  • Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 60 days before screening
  • Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
  • Heart failure classified as being in New York Heart Association (NYHA) Class IV at screening
  • Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or a medication with GLP-1 activity within 90 days before screening
  • End stage renal disease defined as estimated glomerular filtration rate (eGFR) < 15 millileters per minutes per 1.73^2 (mL/min/1.73 m^2), as measured by the central laboratory at screening
  • Chronic or intermittent haemodialysis or peritoneal dialysis

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
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide s.c. once weekly for 235 weeks.
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously.
Experimental: CagriSema
Participants will receive cagrilintide and semaglutide subcutaneously (s.c.) once-weekly after a dose escalation period of 16 weeks during the maintenance period of 219 weeks.
Participants will receive cagrilintide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.
Participants will receive semaglutide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first occurrence of 3-point major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke
Time Frame: From baseline (week 0) to end of study (up to 242 weeks or more)
Measured in days.
From baseline (week 0) to end of study (up to 242 weeks or more)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction and non-fatal stroke
Time Frame: From baseline (week 0) to end of study (up to 242 weeks or more)
Measured in days.
From baseline (week 0) to end of study (up to 242 weeks or more)
Time to first occurrence of myocardial infarction (fatal and non-fatal)
Time Frame: From baseline (week 0) to end of study (up to 242 weeks or more)
Measured in days.
From baseline (week 0) to end of study (up to 242 weeks or more)
Time to first occurrence of stroke (fatal and non-fatal)
Time Frame: From baseline (week 0) to end of study (up to 242 weeks or more)
Measured in days.
From baseline (week 0) to end of study (up to 242 weeks or more)
Relative change in body weight
Time Frame: From baseline (week 0) to 120 weeks
Measured in percentage (%).
From baseline (week 0) to 120 weeks
Change in waist circumference
Time Frame: From baseline (week 0) to 120 weeks
Measured in centimeters (cm).
From baseline (week 0) to 120 weeks
Change in systolic blood pressure (SBP)
Time Frame: From baseline (week 0) to 120 weeks
Measured in millimeters of mercury (mmHg).
From baseline (week 0) to 120 weeks
Change in diastolic blood pressure (DBP)
Time Frame: From baseline (week 0) to 120 weeks
Measured in mmHg.
From baseline (week 0) to 120 weeks
Change in glycated haemoglobin (HbA1c)
Time Frame: From baseline (week 0) to 120 weeks
Measured in percentage-points.
From baseline (week 0) to 120 weeks
Number of treatment emergent serious adverse events (TESAEs)
Time Frame: From baseline (week 0) to end of study (up to 242 weeks or more)
Measured in count of events.
From baseline (week 0) to end of study (up to 242 weeks or more)
Number of event adjudication committee (EAC)-confirmed malignant neoplasms
Time Frame: From baseline (week 0) to end of study (up to 242 weeks or more)
Measured as count of events.
From baseline (week 0) to end of study (up to 242 weeks or more)
Number of severe hypoglycaemic episodes (level 3) (only for participants with type 2 diabetes mellitus [T2D] at screening)
Time Frame: From baseline (week 0) to end of study (up to 242 weeks or more)
Measured as count of events.
From baseline (week 0) to end of study (up to 242 weeks or more)
Time to first occurrence of a composite endpoint: Onset of persistent ≥40% reduction in eGFRcr (CKD-EPI), eGFRcr (CKD-EPI) <15 mL/min/1.73 m^2, Initiation of chronic kidney replacement therapy, Kidney death and CV death
Time Frame: From baseline (week 0) to end of study (up to 242 weeks or more)
CKD-EPI is Chronic Kidney Disease Epidemiology Collaboration. Measured in days.
From baseline (week 0) to end of study (up to 242 weeks or more)
Time to first occurrence of composite endpoint consisting of: Onset of persistent macro albuminuria, ≥40% reduction in eGFRcr (CKD-EPI), eGFRcr (CKD-EPI) <15 mL/min/1.73 m^2, Initiation of chronic kidney replacement therapy and kidney death
Time Frame: From baseline (week 0) to end of study (up to 242 weeks or more)
CKD-EPI is Chronic Kidney Disease Epidemiology Collaboration. Measured in days.
From baseline (week 0) to end of study (up to 242 weeks or more)
Time to first occurrence of an expanded 5-point MACE composite endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation and unstable angina requiring hospitalisation
Time Frame: From baseline (week 0) to end of study (up to 242 weeks or more)
Measured in days.
From baseline (week 0) to end of study (up to 242 weeks or more)
Change in eGFRcr (CKD-EPI)
Time Frame: From baseline (week 0) to 120 weeks
Measured in milliliter per min per 1.73 square meter (mL/min/1.73m^2).
From baseline (week 0) to 120 weeks
Ratio to baseline in Urine albumin-to-creatinine ratio (UACR)
Time Frame: From baseline (week 0) to 120 weeks
Measured in ratio.
From baseline (week 0) to 120 weeks
Change in waist-to-height ratio
Time Frame: From baseline (week 0) to 120 weeks
Measured in ratio.
From baseline (week 0) to 120 weeks
Ratio to baseline in lipids: Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, triglycerides and free fatty acids
Time Frame: From baseline (week 0) to 120 weeks
Measured in ratio.
From baseline (week 0) to 120 weeks

Collaborators and Investigators

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

Investigators

  • 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 (Actual)

March 1, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 13, 2027

Study Registration Dates

First Submitted

December 20, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

January 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • NN9838-4942
  • U1111-1270-0943 (Other Identifier: World Health Organization (WHO))
  • 2021-005855-35 (EudraCT Number)
  • jRCT2031220672 (Registry Identifier: jrct (Japan))

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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