A Research Study to Investigate How Well the Medicine CagriSema Lowers High Blood Pressure in People Living With High Blood Pressure and Obesity (REDEFINE)
30. oktober 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1408
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Studiesteder
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Buenos Aires, Argentina, C1425AGC
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
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CABA, Argentina, C1060ABA
- CEDIC Centro de Investigación Clínica
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CABA, Argentina, C1120AAC
- Centro Médico Viamonte SRL
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Rosario, Argentina, S2000PBJ
- CAICI
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Santiago del Estero, Argentina, G4200
- Sanatorio Norte
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1128 AAF
- Mautalen Salud e investigación
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CABA, Buenos Aires, Argentina, C1440CFD
- CEMEDIC
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Capital Federal, Buenos Aires, Argentina, C1056ABI
- Centro de Investigaciones Metabólicas
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La Pampa Province
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Santa Rosa, La Pampa Province, Argentina, 6300
- Fundación CESIM
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Mendoza Province
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Godoy Cruz, Mendoza, Mendoza Province, Argentina, 5501
- Hospital Español de Mendoza
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New South Wales
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Castle Hill, New South Wales, Australien, 2154
- Castle Hill Medical Centre
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Darlinghurst, New South Wales, Australien, 2010
- Momentum Clinical Research Darlinghurst
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Maroubra, New South Wales, Australien, 2035
- Australian Clinical Research Network
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Sydney, New South Wales, Australien, 2148
- Roger Chih Yu Chen
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Queensland
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Douglas, Queensland, Australien, 4814
- Townsville University Hospital
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Victoria
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Torquay, Victoria, Australien, 3228
- Clinical Trials Institute
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Western Australia
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Bunbury, Western Australia, Australien, 6230
- Brecken Health Clinical Trials
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Perth, Western Australia, Australien, 6000
- Dobney Hypertension Centre
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Alken, Belgien, 3570
- Anima Research Center
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Bonheiden, Belgien, 2820
- Imelda
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Genk, Belgien, 3600
- Ziekenhuis Oost-Limburg
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Ghent, Belgien, 9000
- Universitair Ziekenhuis Gent
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Leuven, Belgien, 3000
- Uz Leuven
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Mons, Belgien, 7000
- CHU Helora - Hôpital de Mons - Site Constantinople
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 30455-610
- Centro Universitário de Belo Horizonte (UNIBH)
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Paraná
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Curitiba, Paraná, Brasilien, 80230-130
- PUCPR - Pontificia Universidade Catolica do Parana
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São Paulo
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Bragança Paulista, São Paulo, Brasilien, 12916-542
- Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista
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Campinas, São Paulo, Brasilien, 13092-133
- i9 Pesquisas Clínicas
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Campinas, São Paulo, Brasilien, 13060-803
- PUCCAMP - Hospital e Maternidade Celso Pierro
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Campinas, São Paulo, Brasilien, 13083-887
- Centro de Pesquisa Clínica da Faculdade de Ciências Médicas - Unicamp
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São Paulo, São Paulo, Brasilien, 05403-000
- Instituto do Coração - HCFMUSP
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São Paulo, São Paulo, Brasilien, 04038-032
- IBTED Tecnologia e Educação em Diabetes - EPP
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São Paulo, São Paulo, Brasilien, 01228-000
- CPQuali Pesquisa Clínica Ltda
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Burgas, Bulgarien, 8000
- Medical center Medconsult Burgas OOD
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Panagyurishte, Bulgarien, 4500
- MHAT - Uni Hospital OOD, Clinic of Cardiology
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Pernik, Bulgarien, 2308
- MHAT Rahila Angelova AD, Research Center
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Plovdiv, Bulgarien, 4002
- Dr. Ilcho Ilchev - AIPSMC - Cardiology EOOD
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Shumen, Bulgarien, 9700
- MHAT Shumen AD
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Sliven, Bulgarien, 8800
- GPSMC - Inacor OOD
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Sofia, Bulgarien, 1202
- DCC Ascendent OOD
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Sofia, Bulgarien, 1231
- MC Dr. Atanasov EOOD
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Sofia, Bulgarien, 1510
- MC Hera EOOD - Sofia
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Sofia, Bulgarien, 1431
- UMHAT Aleksandrovska EAD, Clinic of Cardiology
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Sofia, Bulgarien, 1750
- MHAT Sveta Anna Sofia AD, Clinic of Cardiology
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Sofia, Bulgarien, 1527
- UMHAT Tsaritsa Yoanna - ISUL EAD, Cardiology
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Sofia, Bulgarien, 1612
- Nevrovita - Medical Center OOD
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Varna, Bulgarien, 9010
- UMHAT Sveta Marina EAD, Clinic of Internal Diseases
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Varna, Bulgarien, 9009
- SHATC - Cardiolife OOD - Varna
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Québec, Canada, G1V 4T3
- Diex Recherche Quebec
-
Québec, Canada, G1V 4G5
- IUCPQ - Universite Laval
-
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British Columbia
-
Vancouver, British Columbia, Canada, V6Z 2T1
- Spectrum Health Clinic
-
Victoria, British Columbia, Canada, V8V 4A1
- Dr. M.B. Jones Inc
-
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New Brunswick
-
Moncton, New Brunswick, Canada, E1G 1A7
- G.A. Research Associates Ltd.
-
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Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Health Authority
-
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Ontario
-
Hamilton, Ontario, Canada, L8L 5G4
- Premier Clinical Trial Research Network (PCTRN)
-
Hamilton, Ontario, Canada, L8L 5G4
- Hamilton Medical Research Group
-
London, Ontario, Canada, N5W 6A2
- Milestone Research
-
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Quebec
-
Trois-Rivières, Quebec, Canada, G9A 4P3
- Diex Recherche Trois-Rivieres
-
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Herning, Danmark, 7400
- Regionshospitalet Gødstrup - Universitetsklinikken for Nyresygdomme og Blodtryksforhøjelse
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Holbæk, Danmark, 4300
- Holbæk Sygehus - Forskningsenheden, Medicinsk Afdeling, afs. 44-4
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Hvidovre, Danmark, 2650
- Hvidovre Hospital Endokrinologisk forsknings afsnit 159
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Viborg, Danmark, 8800
- Viborg Sygehus
-
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Region Syddanmark
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Esbjerg, Region Syddanmark, Danmark, 6700
- Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
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Bristol, Det Forenede Kongerige, BS37 4AX
- West Walk Surgery
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Cambridge, Det Forenede Kongerige, CB2 0QQ
- Addenbrooke's Hospital_Cambridge
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Chippenham, Det Forenede Kongerige, SN14 6GT
- Hathaway Medical Centre
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Harrow, Det Forenede Kongerige, HA3 7LT
- Belmont Health Centre
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Hounslow, Det Forenede Kongerige, TW4 7NJ
- HMC Health - Heston - The Meadows Centre for Health
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London, Det Forenede Kongerige, EC1M 6BQ
- William Harvey Research Institute
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London, Det Forenede Kongerige, SW1P 2PF
- Healthcare Central London - South Westminster Centre for Health
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Cambridgeshire
-
Wisbech, Cambridgeshire, Det Forenede Kongerige, PE13 3UZ
- Trinity Surgery
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Cornwall
-
Newquay, Cornwall, Det Forenede Kongerige, TR7 1RU
- Newquay Health Centre
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Hertfordshire
-
Bushey, Hertfordshire, Det Forenede Kongerige, WD23 2NN
- Attenborough Surgery
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California
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Concord, California, Forenede Stater, 94520
- John Muir Physicians Network
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Costa Mesa, California, Forenede Stater, 92627
- Aurora FDRC Inc.
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Fullerton, California, Forenede Stater, 92835
- Providence Medical Foundation
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Montclair, California, Forenede Stater, 91763
- Catalina Research Institute, LLC
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Palm Springs, California, Forenede Stater, 92262
- Desert Oasis Hlthcr Med Group
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San Dimas, California, Forenede Stater, 91773
- N America Res Inst - San Dimas
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Connecticut
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Waterbury, Connecticut, Forenede Stater, 06708
- Chase Medical Research LLC
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Florida
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Clearwater, Florida, Forenede Stater, 33765
- Clinical Res Of W Florida Inc
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Ocala, Florida, Forenede Stater, 34470
- Renstar Medical Research
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Orlando, Florida, Forenede Stater, 32825
- Florida Institute for Clinical research
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Georgia
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Albany, Georgia, Forenede Stater, 31707
- Javara Inc. / Privia Medical Group Georgia LLC
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Conyers, Georgia, Forenede Stater, 30094
- Hope Clin Res & Wellness
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Roswell, Georgia, Forenede Stater, 30076
- Endocrine Research Solutions, Inc
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Savannah, Georgia, Forenede Stater, 31406
- Javara Inc. / Privia Medical Group Georgia LLC
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Illinois
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Chicago, Illinois, Forenede Stater, 60640
- Great Lakes Clinical Trials
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Morton, Illinois, Forenede Stater, 61550
- Koch Research
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Skokie, Illinois, Forenede Stater, 60077
- Evanston Premier Hlthcr Res
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Skokie, Illinois, Forenede Stater, 60077
- Endeavor Health
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Springfield, Illinois, Forenede Stater, 62702
- SIU Medicine
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46260
- Midwest Inst For Clin Res
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Iowa
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West Des Moines, Iowa, Forenede Stater, 50266
- Iowa Diabetes Research
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Kentucky
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Bowling Green, Kentucky, Forenede Stater, 42101
- Graves Gibert Clinic
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Louisville, Kentucky, Forenede Stater, 40213
- Monroe Biomedical Research, LLC
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Michigan
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Buckley, Michigan, Forenede Stater, 49620
- Northern Pines Hlth Ctr, PC
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Flint, Michigan, Forenede Stater, 48504
- Aa Mrc Llc
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Missouri
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City of Saint Peters, Missouri, Forenede Stater, 63303
- StudyMetrix Research LLC
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St Louis, Missouri, Forenede Stater, 63128
- Amicis Centers of Clinical Research
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New Hampshire
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Portsmouth, New Hampshire, Forenede Stater, 03801
- Seacoast Kidney & Htn Specialists
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New York
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West Seneca, New York, Forenede Stater, 14224
- Southgate Medical Group, LLP
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Westfield, New York, Forenede Stater, 14787
- Great Lakes Medical Research
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North Carolina
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Raleigh, North Carolina, Forenede Stater, 27609
- Medication Management, LLC
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Raleigh, North Carolina, Forenede Stater, 27609
- Accellacare_NC
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Statesville, North Carolina, Forenede Stater, 28625
- Piedmont Healthcare, Inc.
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Ohio
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Canton, Ohio, Forenede Stater, 44718
- Diab & Endo Assoc of Stark Co
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Wadsworth, Ohio, Forenede Stater, 44281-9236
- Family Practice Center of Wadsworth Inc.
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Oklahoma
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Norman, Oklahoma, Forenede Stater, 73072
- Lynn Institute of Norman
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Rhode Island
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Cumberland, Rhode Island, Forenede Stater, 02864
- Clinical Res Collaborative
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South Carolina
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North Charleston, South Carolina, Forenede Stater, 29405
- Coastal Carolina Res Ctr
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Spartanburg, South Carolina, Forenede Stater, 29303
- Spartanburg Medical Research
-
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Tennessee
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Bristol, Tennessee, Forenede Stater, 37620
- Holston Medical Group Pc
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Kingsport, Tennessee, Forenede Stater, 37660
- Holston Medical Group
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Nashville, Tennessee, Forenede Stater, 37203
- Clinical Research Associates
-
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Texas
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Amarillo, Texas, Forenede Stater, 79124
- Amarillo Med Spec LLP
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Austin, Texas, Forenede Stater, 78731
- Texas Diabetes & Endocrinology
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Austin, Texas, Forenede Stater, 78749
- Texas Diabetes & Endocrinology, P.A._Austin
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Bellaire, Texas, Forenede Stater, 77401
- Juno Research, LLC
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Dallas, Texas, Forenede Stater, 75231
- North Texas Endocrine Center
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Dallas, Texas, Forenede Stater, 75226
- Baylor Jack and Jane Hamilton
-
Dallas, Texas, Forenede Stater, 75230
- Velocity Clin Res, Dallas
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Houston, Texas, Forenede Stater, 77079
- The Endocrine Center
-
Houston, Texas, Forenede Stater, 77036
- Discovery MM Services Inc
-
Lampasas, Texas, Forenede Stater, 76550
- Radiance Clinical Research
-
Longview, Texas, Forenede Stater, 75605
- DCOL Ctr for Clin Res
-
San Antonio, Texas, Forenede Stater, 78212
- Clinical Advancement Center
-
San Antonio, Texas, Forenede Stater, 78233
- Northeast Clinical Research of San Antonio
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Shavano Park, Texas, Forenede Stater, 78231
- Consano Clinical Research, LLC
-
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Washington
-
Renton, Washington, Forenede Stater, 98057
- Rainier Clin Res Ctr Inc
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Deventer, Holland, 7416 SE
- Deventer Ziekenhuis - Interne geneeskunde
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Dordrecht, Holland, 3318 AT
- Albert Schweitzer Zkh, Dordwijk - Nefrologie
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Eindhoven, Holland, 5623 EJ
- Catharina Zkh Eindhoven - Interne geneeskunde
-
Haarlem, Holland, 2035 RC
- Spaarne Gasthuis Haarlem - Interne
-
Heerlen, Holland, 6419 PC
- Zuyderland ziekenhuis - Interne
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Hoogeveen, Holland, 7909 AA
- Bethesda Diabetes Research Center
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Nijmegen, Holland, 6525 GA
- RadboudUMC - Vasculaire geneeskunde
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Utrecht, Holland, 3584 CX
- UMC Utrecht - Vasculaire geneeskunde
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Apulia
-
Bari, Apulia, Italien, 70124
- AUO Consorziale Policlinico Bari - UOC Medicina Interna Universitaria (Cesare Frugoni)
-
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Calabria
-
Catanzaro, Calabria, Italien, 88100
- AOU Renato Dulbecco - Unità Operativa Complessa Medicina Interna
-
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Emilia-Romagna
-
Ferrara, Emilia-Romagna, Italien, 44124
- Arcispedale Sant'Anna (Cona) - Medicina Interna Universitaria
-
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Lazio
-
Rome, Lazio, Italien, 00189
- Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Cardiologia
-
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Lombardy
-
Brescia, Lombardy, Italien, 25123
- Spedali Civili Brescia - U.O. Medicina Generale 2
-
Milan, Lombardy, Italien, 20162
- Grande Ospedale Metropolitano Niguarda - Dipartimento di Cardiologia Clinica
-
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Molise
-
Pozzilli (IS), Molise, Italien, 86077
- NeuroMed S.p.A. - Dipartimento di Angio-Cardio-Neurologia
-
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RM
-
Rome, RM, Italien, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCS
-
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Sicily
-
Palermo, Sicily, Italien, 90127
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
-
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The Marches
-
Ancorna, The Marches, Italien, 60127
- INRCA Ancona - UOC Clinica Medica e Geriatrica
-
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Tuscany
-
Siena, Tuscany, Italien, 53100
- Azienda Ospedaliero Universitaria Senese - Endocrinologia
-
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Veneto
-
Padova, Veneto, Italien, 35128
- Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica
-
-
-
-
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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
-
-
-
-
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Elblag, Polen, 82-300
- Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
-
Gdansk, Polen, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Gdansk, Polen, 80-462
- Copernicus Podmiot Leczniczy Sp. z o.o.
-
Krakow, Polen, 30-721
- Linden sp. z o.o. sp. k.
-
Krakow, Polen, 31-322
- Gyncentrum Sp. z o. o.
-
Lodz, Polen, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
-
Rzeszów, Polen, 35-205
- EMED Centrum Usług Medycznych Ewa Smialek
-
Siedlce, Polen, 08-110
- Lukmed 2 Sp. z o.o.
-
Starachowice, Polen, 27-200
- Star Badania Kliniczne Sp. z o.o
-
Warsaw, Polen, 04-628
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
-
Świnoujście, Polen, 72-600
- Balticmed Świnoujście Sp. z o. o.
-
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Masovian Voivodeship
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Grodzisk Mazowiecki, Masovian Voivodeship, Polen, 05-825
- Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II
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Ostrów Mazowiecka, Masovian Voivodeship, Polen, 07-300
- Kresmed Sp. z o. o.
-
Warsaw, Masovian Voivodeship, Polen, 04-635
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
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Pomeranian Voivodeship
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Gdynia, Pomeranian Voivodeship, Polen, 81-157
- Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
-
-
-
-
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Ponce, Puerto Rico, 00716
- Ponce Med School Found Inc
-
-
-
-
-
Badajoz, Spanien, 06080
- Hospital Universitario de Badajoz
-
Barcelona, Spanien, 08022
- Centro Médico Quirón-Teknon
-
Barcelona, Spanien, 08036
- Clinic Barcelona_Endocrinología
-
León, Spanien, 24008
- H. de León_Endocrinología
-
Madrid, Spanien, 28016
- Hospital Universitario Sanitas Virgen del Mar
-
Madrid, Spanien, 28009
- H.G.Marañón_Endocrino-Obesidad
-
Santander, Spanien, 39008
- H. Univ. Marqués de Valdecilla_Endocrinología
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Santiago de Compostela, Spanien, 15702
- Clínica Gaias Santiago
-
-
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Gauteng
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Johannesburg, Gauteng, Sydafrika, 2013
- Wits Bara Clinical Trial Site
-
Johannesburg, Gauteng, Sydafrika, 1818
- Soweto Clinical Trial Centre
-
Midrand, Gauteng, Sydafrika, 1685
- Dr A Jacovides and Partners Inc
-
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KwaZulu-Natal
-
Durban, KwaZulu-Natal, Sydafrika, 4091
- Dr Vawda's site
-
eMkhomazi, KwaZulu-Natal, Sydafrika, 4170
- Dr T Padayachee
-
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Lenasia
-
Gauteng, Lenasia, Sydafrika, 1827
- Dr Moosa's Rooms
-
-
-
-
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Busan, Sydkorea, 49201
- Dong-A University Hospital_Family Medicine
-
Daegu, Sydkorea, 41944
- Kyungpook National University Hospital_Family Medicine
-
Daegu, Sydkorea, 42601
- Keimyung University Dongsan Hospital_Endocrinology
-
Daejeon, Sydkorea, 35365
- Konyang University Hospital_Family Medicine
-
Seoul, Sydkorea, 03722
- Severance Hospital, Yonsei University Health System_Family Medicine
-
Seoul, Sydkorea, 04763
- Hanyang University Seoul Hospital_Family Medicine
-
-
Gyeonggi-do
-
Anyang-si, Gyeonggi-do, Sydkorea, 14068
- Hallym University Sacred Heart Hospital_Family Medicine
-
Bucheon-si, Gyeonggi-do, Sydkorea, 14647
- The Catholic University of Korea, Bucheon ST. Mary's Hospital_Endocrinology
-
Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Seoul National University Bundang Hospital_Family Medicine
-
-
Gyeongsangnam-do
-
Yangsan, Gyeongsangnam-do, Sydkorea, 50612
- Pusan National University Yangsan Hospital_Family Medicine
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-
-
-
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Berlin, Tyskland, 13405
- KARDIA - Dr. Hashemi
-
Duisburg, Tyskland, 47269
- MVZ Hausärzte Großenbaum GmbH Duisburg
-
Elsterwerda, Tyskland, 04910
- Zentrum für klinische Studien Südbrandenburg GmbH
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Frankfurt, Tyskland, 60590
- Uniklinik FFM - Nephrologie
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Hamburg, Tyskland, 22607
- Wendisch - Dahl Hamburg - DZHW
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Münster, Tyskland, 48145
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
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Oldenburg in Holstein, Tyskland, 23758
- RED-Institut für medizinische Forschung und Fortbildung GmbH
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-
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-
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Budapest, Ungarn, H-1141
- Cardiogeneral Kft.
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Budapest, Ungarn, 1046
- Újpesti Egészségközpont
-
Budapest, Ungarn, H-1021
- Budapesti Szent Ferenc Kórház
-
Békéscsaba, Ungarn, 5600
- Trial Pharma Kft.
-
Békéscsaba, Ungarn, 5600
- Békés Vármegyei Központi Kórház
-
Szeged, Ungarn, 6724
- KomplexLabor Diagnosztika Kft.
-
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Bács-Kiskun county
-
Kalocsa, Bács-Kiskun county, Ungarn, 6300
- Stúdium Egészségház Kft.
-
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Hajdú-Bihar
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Debrecen, Hajdú-Bihar, Ungarn, 4032
- Debreceni Egyetem
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: CagriSema
Participants will receive CagriSema subcutaneously once weekly. |
CagriSema will be administered subcutaneously. |
|
Aktiv komparator: Semaglutide
Participants will receive semaglutide subcutaneously once weekly. |
Semaglutide will be administered subcutaneously. |
|
Aktiv komparator: Cagrilintide
Participants will receive cagrilintide subcutaneously once weekly. |
Cagrilintide will be administered subcutaneously. |
|
Placebo komparator: Placebo
Participants will receive placebo subcutaneously once weekly. |
Placebo will be administered subcutaneously. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP)
Tidsramme: From baseline (week 0) to week 32
|
Measured in millimeters of mercury (mmHg). |
From baseline (week 0) to week 32
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
CagriSema versus Semaglutide and Cagrilintide : Change in in-office systolic blood pressure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At Week 32
|
Measured as Count of participants. |
At Week 32
|
|
Change in body weight (%)
Tidsramme: From baseline (week 0) to week 32
|
Measured in percentage (%). |
From baseline (week 0) to week 32
|
|
Change in body weight (Kg)
Tidsramme: From baseline (week 0) to week 32
|
Measured in Kilograms (kg). |
From baseline (week 0) to week 32
|
|
Change in waist circumference
Tidsramme: 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
Tidsramme: 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
Tidsramme: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: HDL cholesterol
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
|
Ratio to baseline of lipids: Triglycerides
Tidsramme: 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)
Tidsramme: From baseline (week 0) to week 32
|
Measured in Ratio. |
From baseline (week 0) to week 32
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
11. november 2026
Primær færdiggørelse (Anslået)
1. juni 2028
Studieafslutning (Anslået)
13. juli 2028
Datoer for studieregistrering
Først indsendt
30. oktober 2026
Først indsendt, der opfyldte QC-kriterier
30. oktober 2026
Først opslået (Faktiske)
5. november 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NN9838-8768
- U1111-1338-1943 (Anden identifikator: World Health Organization (WHO))
- 2026-526360-21 (Anden identifikator: European Medical Agency (EMA))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .