AMBITION 3: A Research Study Investigating How Well Zenagamtide at Higher Dose Levels Lowers Blood Sugar and Body Weight Compared to Semaglutide in People With Type 2 Diabetes Treated With Metformin, SGLT2i, or Both (AMBITION 3)
6. november 2026 opdateret af: Novo Nordisk A/S
Efficacy and Safety of Zenagamtide s.c. Once Weekly Compared to Semaglutide s.c. Once Weekly at Higher Dose Levels in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2i, or Both (AMBITION 3)
The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have type 2 diabetes. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will get one of the following: Zenagamtide (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator).
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1200
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, C1015
- OMI- Organización Médica de Investigación
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San Nicolás, Argentina, B2900
- Instituto de Investigaciones Clinicas San Nicolás
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Santa Fe, Argentina, S3000FSO
- CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
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Santa Fe, Argentina, S2152BOF
- Centro de Investigaciones Clinica Baigorria
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Buenos Aires
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1424CIQ
- CICEMO- Consultorio (Av Directorio)
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Mar del Plata, Buenos Aires, Argentina, B7600FZN
- Instituto de Investigaciones Clinicas Mar Del Plata
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Santa Fe Province
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Rafaela, Santa Fe Province, Argentina, S2300
- Mains Bleues SA
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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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Macquarie Park, New South Wales, Australien, 2109
- Macquarie University - Clinical Trials Unit
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Queensland
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Douglass, Queensland, Australien, 4814
- Townsville University Hospital - Diabetes and Endocrine Department
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Meadowbrook, Queensland, Australien, 4131
- Logan Hospital
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Toowoomba, Queensland, Australien, 4350
- Regional Research Institute
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Victoria
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Clayton, Victoria, Australien, 3168
- Monash Medical Centre - Bone and Muscle Research Group
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Parkville, Victoria, Australien, 3050
- The Royal Melbourne Hospital - Diabetes & Endocrinology Department
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Torquay, Victoria, Australien, 3228
- Clinical Trials Institute
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Paraná
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Curitiba, Paraná, Brasilien, 80810-040
- Centro de Diabetes Curitiba
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
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São Paulo
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Campinas, São Paulo, Brasilien, 13060-803
- PUCCAMP - Hospital e Maternidade Celso Pierro
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São Paulo, São Paulo, Brasilien, 05403-000
- Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP
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São Paulo, São Paulo, Brasilien, 01228-000
- CPQuali Pesquisa Clínica Ltda
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São Paulo, São Paulo, Brasilien, 01228-200
- CPCLIN - Centro de Pesquisas Clínicas
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Gabrovo, Bulgarien, 5312
- Medical Center New Polyclinic Gabrovo OOD
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Rousse, Bulgarien, 7002
- UMHAT Kanev AD, Second Department of Internal Diseases
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Sliven, Bulgarien, 8800
- MHAT Dr. Ivan Seliminski - Sliven AD
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Smolyan, Bulgarien, 4700
- Medical center Smolyan clinical research OOD
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Sofia, Bulgarien, 1527
- MC Orthopaedic Center Kinov EOOD
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Sofia, Bulgarien, 1431
- UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases
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Sofia, Bulgarien, 1582
- Medical centre Druzhba EOOD
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Sofia, Bulgarien, 1616
- Medical Center - Sveti Dimitar EOOD
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Varna, Bulgarien, 9000
- Medical center Higiya OOD
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Québec, Canada, G1V 4W2
- Clinique des Maladies Lipidiques de Quebec Inc.
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British Columbia
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Surrey, British Columbia, Canada, V4A 0C1
- Hilltop Medical Clinic
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Surrey, British Columbia, Canada, V3T0X6
- TLC Diabetes and Endocrinology
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New Brunswick
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Moncton, New Brunswick, Canada, E1G 1A7
- G.A. Research Associates Ltd.
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Ontario
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Brampton, Ontario, Canada, L6S 0C6
- Centricity Research Brampton Endocrinology
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Etobicoke, Ontario, Canada, M9R 4E1
- Centricity Research Etobicoke Endocrinology
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Quebec
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Montreal, Quebec, Canada, H4N 2W2
- Centre Medical Acadie
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Aarhus, Danmark, 8200
- Aarhus Universitetshospital, Steno Diabetes Center Aarhus
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Gandrup, Danmark, 9362
- Sanos Clinic - Gandrup
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Herlev, Danmark, 2730
- Steno Diabetes Center Copenhagen
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Odense C, Danmark, 5000
- Steno Diabetes Center Odense
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Region Sjælland
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Køge, Region Sjælland, Danmark, 4600
- Sjællands Universitetshospital, Køge - Medicinsk Afdeling
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Blackburn, Det Forenede Kongerige, BB2 1AX
- Oakenhurst Medical Practice
-
Chippenham, Det Forenede Kongerige, SN14 6GT
- Hathaway Medical Centre
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London, Det Forenede Kongerige, SW1P 2PF
- Healthcare Central London - South Westminster Centre for Health
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Nantwich, Det Forenede Kongerige, CW5 5NX
- Kiltearn Medical Centre
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Rotherham, Det Forenede Kongerige, S61 1AH
- Woodstock Bower Group Practice
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Sandbach, Det Forenede Kongerige, CW11 1EQ
- Ashfields Primary Care Centre
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Swansea, Det Forenede Kongerige, SA2 8PP
- Joint Clinical Research Facility - Swansea
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Cornwall
-
Liskeard, Cornwall, Det Forenede Kongerige, PL14 3XA
- Oak Tree Surgery
-
Truro, Cornwall, Det Forenede Kongerige, TR1 3LJ
- Royal Cornwall Hospital (Treliske) - Diabetes
-
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Devon
-
Torquay, Devon, Det Forenede Kongerige, TQ1 4QX
- Brunel Medical Practice
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Hertfordshire
-
Bushey, Hertfordshire, Det Forenede Kongerige, WD23 2NN
- Attenborough Surgery
-
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Arizona
-
Phoenix, Arizona, Forenede Stater, 85016
- Rio Clinical Trials Arizona
-
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California
-
La Jolla, California, Forenede Stater, 92037
- Scripps Whittier Diabetes Inst
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La Mesa, California, Forenede Stater, 91942
- Diabetes & Endocrine Specialists - La Mesa
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Lancaster, California, Forenede Stater, 93534
- First Valley Med Grp Lancaster
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Los Angeles, California, Forenede Stater, 90015
- Los Angeles Institute for Metabolic Research
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Northridge, California, Forenede Stater, 91325
- Valley Clinical Trials, Inc.
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Palm Springs, California, Forenede Stater, 92262
- Desert Oasis Hlthcr Med Group
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San Diego, California, Forenede Stater, 92111
- Linda Vista Health Care Ctr
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Santa Ana, California, Forenede Stater, 92701
- Southern Cal Clinical Research
-
Spring Valley, California, Forenede Stater, 91978
- Encompass Clinical Research_Spring Valley
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Walnut Creek, California, Forenede Stater, 94598
- Diablo Clinical Research, Inc.
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Connecticut
-
Waterbury, Connecticut, Forenede Stater, 06708
- Chase Medical Research LLC
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Florida
-
Hollywood, Florida, Forenede Stater, 33024
- Encore Medical Research LLC
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Jacksonville, Florida, Forenede Stater, 32256
- University of Florida Cardiology
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Miami, Florida, Forenede Stater, 33165
- New Horizon Research Center
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Miami, Florida, Forenede Stater, 33155
- My Preferred Research
-
Miami, Florida, Forenede Stater, 33173
- GTL Med & Res Group
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Miami Gardens, Florida, Forenede Stater, 33014
- Life Medical Research Group
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Miramar, Florida, Forenede Stater, 33027
- South Broward Research LLC
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Mt. Dora, Florida, Forenede Stater, 32757
- Adult Medicine of Lake County, Inc
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Ocoee, Florida, Forenede Stater, 34761
- West Orange Endocrinology
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Orlando, Florida, Forenede Stater, 32825
- Florida Institute for Clinical research
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Tampa, Florida, Forenede Stater, 36607
- True Blue Clinical Research
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Weston, Florida, Forenede Stater, 33331
- Encore Medical Research of Weston
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Idaho
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Meridian, Idaho, Forenede Stater, 83646
- Solaris Clinical Research
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Illinois
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Gurnee, Illinois, Forenede Stater, 60031
- Clinical Invest Special_Gurnee
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Kansas
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Topeka, Kansas, Forenede Stater, 66606
- Cotton O'Neil Diab & Endo Ctr
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Maryland
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Olney, Maryland, Forenede Stater, 20832
- MedStar Health Research Institute
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Rockville, Maryland, Forenede Stater, 20852
- Endo And Metab Cons
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Brigham & Women's Hospital
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Michigan
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Flint, Michigan, Forenede Stater, 48532
- Elite Clinical Research
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Missouri
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City of Saint Peters, Missouri, Forenede Stater, 63303
- StudyMetrix Research LLC
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89148
- Palm Research Center Inc-Vegas
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New Hampshire
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Nashua, New Hampshire, Forenede Stater, 03060
- Southern NH Diabetes and Endo_Nashua
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New York
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Albany, New York, Forenede Stater, 12203
- AMC Community Endocrinology
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West Seneca, New York, Forenede Stater, 14224
- Southgate Medical Group, LLP
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North Carolina
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Greensboro, North Carolina, Forenede Stater, 27408
- PharmQuest Life Sciences LLC
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Monroe, North Carolina, Forenede Stater, 28112
- Monroe Biomedical Research, LLC
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Wilmington, North Carolina, Forenede Stater, 28401
- Accellacare
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Ohio
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Canton, Ohio, Forenede Stater, 44718
- Diab & Endo Assoc of Stark Co
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29407
- DelRicht Research at Newton Family Medicine
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Spartanburg, South Carolina, Forenede Stater, 29303
- Spartanburg Medical Research
-
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57104
- South Dakota Urban Indian Health
-
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Tennessee
-
Bristol, Tennessee, Forenede Stater, 37620-7352
- Holston Medical Group Pc
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Kingsport, Tennessee, Forenede Stater, 37660
- Holston Medical Group
-
Nashville, Tennessee, Forenede Stater, 37203
- Clinical Research Associates
-
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Texas
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Houston, Texas, Forenede Stater, 77074
- Southwest Clinical Trials
-
Houston, Texas, Forenede Stater, 77024
- Victorium Clinical Research
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Katy, Texas, Forenede Stater, 77450
- Medical Colleagues-Texas LLP
-
San Antonio, Texas, Forenede Stater, 78233
- NE Clin Res of San Antonio
-
San Antonio, Texas, Forenede Stater, 78222
- Pinnacle Clinical Research
-
Shavano Park, Texas, Forenede Stater, 78231
- Consano Clinical Research, LLC
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Weslaco, Texas, Forenede Stater, 78596
- Texas Valley Clinical Research
-
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Utah
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Sandy City, Utah, Forenede Stater, 84093
- Diabetes & Endo Treatment Spec
-
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Washington
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Renton, Washington, Forenede Stater, 98057
- Rainier Clin Res Ctr Inc
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Athens, Grækenland, 11527
- General Hospital Of Athens G Gennimatas - Department of Endocrinology
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Chios, Grækenland, 82131
- General Hospital of Chios "Skilitsio" - Internal Medicine Department
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Goudi/Athens, Grækenland, 11527
- "Laiko" General Hospital of Athens
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Ioannina, Grækenland, 455 00
- University General Hospital of Ioannina, Endocrinology Department and Diabetes Centre
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Kalamata, Grækenland, 24131
- City Hospital Kliniki Monoprosopi I.K.E. - Endocrinology Department
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Larissa, Grækenland, 41110
- University General Hospital of Larissa - Department of Endocrinology and Metabolic Diseases
-
Palaió Fáliro, Grækenland, 17562
- Athens Medical Center S.A. (Iatriko P. Falirou) - Diabetes and Clinical Research Center
-
Thessaloniki, Grækenland, 546 35
- General Hospital Of Thessaloniki G Gennimatas - Internal Medicine Clinic
-
Thessaloniki, Grækenland, 57001
- Thermi Clinic S.A. - Diabetes and Internal Medicine Department
-
Thessaloniki, Grækenland, 54635
- NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes
-
Thessaloniki, Grækenland, 570 10
- Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department
-
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Atlit, Israel, 30300
- Clalit HMO Atlit - Endocrinology Department
-
Beersheba, Israel, 84244
- Clalit HMO Beer Sheva - Endocrinology Department
-
Hadera, Israel, 3810101
- Hillel Yaffe MC - Endocrinology Department
-
Haifa, Israel, 35152
- Linn clinic - Diabetes Unit
-
Haifa, Israel, 6091000
- Bnai Zion MC - Department of Endocrinology
-
Holon, Israel, 58100
- Wolfson MC - Diabetes Clinic
-
Jerusalem, Israel, 9103102
- Shaare Zedek MC - Endocrinology Department
-
Majd el Kurūm, Israel, 1234567
- Clalit HMO Majd Al-Kurum - Endocrinology Department
-
Sakhnin, Israel, 30810
- Clalit HMO Sakhnin - Endocrinology Department
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Roma, Italien, 00161
- Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale
-
Rozzano (MI), Italien, 20089
- IRCCS Humanitas - U.O. Endocrinologia e Diabetologia
-
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Apulia
-
Acquaviva delle Fonti, Apulia, Italien, 70021
- Ente Ecclesiastico Ospedale Generale Regionale Miulli - Endocrinologia
-
Bari, Apulia, Italien, 70124
- AOU Consorziale Policlinico Bari - U.O.C. Endocrinologia Universitaria
-
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Emilia-Romagna
-
Parma, Emilia-Romagna, Italien, 43126
- Azienda Ospedaliera - Universitaria Parma - UOC di Endocrinologia e Malattie del Metabolismo
-
Ravenna, Emilia-Romagna, Italien, 48121
- AUSL Romagna - Distretto di Ravenna - Ospedale Santa Maria delle Croci
-
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Lombardy
-
Milan, Lombardy, Italien, 20157
- ASST Fatebenefratelli Ospedale Luigi Sacco - Malattie Endocrine e Diabetologia
-
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Tuscany
-
Florence, Tuscany, Italien, 50134
- Azienda Ospedaliero Universitaria Careggi - Diabetologia e malattie del metabolismo
-
-
Umbria
-
Perugia, Umbria, Italien, 06129
- A.O.S. Maria della Misericordia - Dipartimento di Medicina Generale e Specialistica
-
-
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-
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Karlovac, Kroatien, 47000
- Opca bolnica Karlovac_Endocrinology
-
Krapinske Toplice, Kroatien, 49217
- Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
-
Osijek, Kroatien, 31 000
- Klinicki bolnicki centar Osijek_Endocrinology
-
Rijeka, Kroatien, 51 000
- Clinical Hospital Centre Rijeka_Endocrinology
-
Slavonski Brod, Kroatien, 35 000
- General Hospital Dr. Josip Bencevic_Diabetic department
-
Solin, Kroatien, 21210
- Poliklinika za oftalmologiju optometriju i neurologiju Lux
-
Zagreb, Kroatien, 10000
- Poliklinika Solmed
-
-
-
-
-
Chojnice, Polen, 89-600
- OptiTrial Sp. z o.o.
-
Lublin, Polen, 20-607
- Reumed Sp. z o.o.
-
Piotrkow Trybunalski, Polen, 97-300
- Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
-
Tarnów, Polen, 33-100
- Metabolica Sp. z o.o.
-
Warsaw, Polen, 00-710
- NBR Polska Tomasz Klodawski
-
Zabrze, Polen, 41-800
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
-
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Dolnosląskie
-
Wroclaw, Dolnosląskie, Polen, 51-124
- Clinical Study Center S.C.
-
-
Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, Polen, 15-435
- NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
-
-
-
-
-
Almada, Portugal, 2805-267
- ULS Almada-Seixal E.P.E. - HGO_Serviço de Endocrinologia
-
Braga, Portugal, 4710-243
- ULS De Braga, E.P.E. - Hospital de Braga_Centro Clínico Académico
-
Coimbra, Portugal, 3000-150
- Casa De Saúde De Santa Filomena S.A._Unidade de Ensaios Clínicos
-
Guarda, Portugal, 6301-858
- ULS Da Guarda E.P.E. - Hospital Sousa Martins_Serviço de Medicina Interna
-
Guimarães, Portugal, 4835-044
- ULS Do Alto Ave, E.P.E - HSOG_Centro de Investigação Clínica
-
Leiria, Portugal, 2400-110
- Hospital São Francisco, S.A_EECC
-
Lisbon, Portugal, 1449-005
- ULS Lisboa Ocidental, E.P.E_Hospital São Francisco Xavier_Hospital de Dia de Especialidades Médicas
-
Lisbon, Portugal, 1350-345
- Hospital CUF Tejo, S.A._Serviço Endocrinologia
-
Ponte de Lima, Portugal, 4990-029
- Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda
-
Porto, Portugal, 4100-180
- CUF Porto_Serviço de Medicina Interna
-
Senhora Da Hora, Matosinhos, Portugal, 4464-513
- ULS De Matosinhos, E.P.E - HPH_Serviço de Endocrinologia
-
Setúbal, Portugal, 2900-722
- Hospital da Luz Setúbal, S.A._Serviço de Medicina Interna
-
Viseu, Portugal, 3500-093
- Casa de Saúde de São Mateus, S.A.
-
-
-
-
-
San Juan, Puerto Rico, 00907
- Solace Clinical Research
-
-
-
-
-
Brasov, Rumænien, 500260
- Diabet Center SRL
-
Paşcani, Rumænien, 705200
- Bella Praxis S.R.L.
-
Piteşti, Rumænien, 110017
- Medis Muntenia SRL
-
-
Bihor County
-
Oradea, Bihor County, Rumænien, 410159
- Grandmed SRL
-
-
Bucharest
-
Bucharest, Bucharest, Rumænien, 020475
- Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
-
-
Maramureş
-
Baia Mare, Maramureş, Rumænien, 430222
- CMI Dr Pop Lavinia
-
-
Prahova
-
Ploieşti, Prahova, Rumænien, 100179
- Diabmed Dr Popescu Alexandrina SRL
-
Ploieşti, Prahova, Rumænien, 100342
- CMI Dr. Busegeanu Mihaela Magdalena
-
-
-
-
-
Al Ahsa, Saudi Arabien, 36428
- National Guard- Alahsa
-
Jeddah, Saudi Arabien, 21423
- King Abdullah International Medical Research Center KAIMRC
-
Jeddah, Saudi Arabien, 21589
- King Fahd Medical Research Center-King Abdulaziz University
-
Khobar, Saudi Arabien, 34445
- King Fahad Hospital of the University
-
Riyadh, Saudi Arabien, 59046
- King Fahad Medical City
-
Riyadh, Saudi Arabien, 12372
- King Khaled University Hospital,King Saud Univ. Med. City
-
Riyadh, Saudi Arabien, 11481
- King Abdullah International Medical Research Center KAIMRC
-
Riyadh, Saudi Arabien, 11499
- King Faisal Specialist Hospital & Research Centre, Riyadh
-
Ulaishah, Riyadh, Saudi Arabien, 12746
- King Saud Medical City Hospital
-
-
-
-
-
Bardejov, Slovakiet, 08501
- DIADA, s.r.o.
-
Košice, Slovakiet, 040 01
- HUMAN-CARE, s.r.o.
-
Martin, Slovakiet, 036 01
- DIAMARTIN, s. r. o.
-
Poprad, Slovakiet, 05801
- DENTAVIA s.r.o.
-
Spišská Nová Ves, Slovakiet, 052 01
- Diabetologicka ambulancia MUDr. Gabriela Zimova
-
Svidník, Slovakiet, 08901
- SIRCO 2, s. r. o.
-
-
-
-
-
Almería, Spanien, 04009
- Centro Periferico De Especialidades Bola Azul
-
Barcelona, Spanien, 08017
- CAP Sarrià
-
Barcelona, Spanien, 08023
- EBA Vallcarca SLP
-
Barcelona, Spanien, 08028
- CAPSBE_CAP Ernest LLuch
-
Barcelona, Spanien, 08360
- CAP Canet de Mar
-
Cabra, Spanien, 14940
- Centro de Salud Cabra Matrona Antonia Mesa
-
Castilleja de la Cuesta, Spanien, 41950
- Hospital Vithas Sevilla
-
La Cuesta (Santa Cruz de Tenerife), Spanien, 38320
- Centro de Salud La Cuesta
-
Pozuelo de Alarcón, Spanien, 28223
- Centro de Salud San Juan de la Cruz
-
Santander, Spanien, 39008
- H. Univ. Marqués de Valdecilla_Endocrinología
-
-
Barcelona
-
Sant Cugat del Vallès, Barcelona, Spanien, 08173
- CAP Turó de Can Mates
-
Vic, Barcelona, Spanien, 08500
- Equip D'assistencia Primaria Vic S.L.P.
-
-
-
-
-
Chrudim III, Tjekkiet, 53701
- INTENDIA klinika s.r.o.
-
Hranice, Tjekkiet, 753 01
- AIDIN VK s.r.o.
-
Olomouc, Tjekkiet, 779 00
- Diabetologické centrum s.r.o.
-
Prague, Tjekkiet, 110 00
- Diabet2 s.r.o.
-
Prague, Tjekkiet, 150 00
- EUC Klinika Praha a.s.
-
Prague, Tjekkiet, 10400
- ENDOTRIAL s.r.o.
-
Prague, Tjekkiet, 149 00
- Milan Kvapil s.r.o.
-
Prague, Tjekkiet, 160 00
- Fledip s.r.o.
-
-
-
-
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Bad Oeynhausen, Tyskland, 32545
- Herz- und Diabeteszentrum NRW - Bad Oeynhausen
-
Berlin, Tyskland, 13597
- Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
-
Duisburg, Tyskland, 47269
- MVZ Hausärzte Großenbaum GmbH Duisburg
-
Falkensee, Tyskland, 14612
- Zentrum für klinische Forschung, Dr. med. Lüdemann
-
Gladbeck, Tyskland, 45968
- Hausarztzentrum Butendorf
-
Hamburg, Tyskland, 22607
- Wendisch - Dahl Hamburg - DZHW
-
Köln-Dünnwald, Tyskland, 51069
- Zentrum für Klinische Forschung Köln-Dünnwald
-
Leipzig, Tyskland, 04249
- Gemeinschaftspraxis Dr. Täschner/Dr. Bonigut
-
Münster, Tyskland, 48153
- MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
-
Pirna, Tyskland, 01796
- Hausärztliche und Diabetologische Praxis Pirna
-
Pohlheim, Tyskland, 35415
- ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
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Reinfeld, Tyskland, 23858
- Praxis Reinfeld Mitte
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Villingen-Schwenningen, Tyskland, 78048
- Praxis für Prävention und Therapie, Drs Jacob
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-
-
-
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Balatonfüred, Ungarn, 8230
- DRC Kft.
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Békéscsaba, Ungarn, 5600
- Trial Pharma Kft.
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Kaposvár, Ungarn, 7400
- Somogy Vármegyei Kaposi Mór Oktató Kórház
-
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Bekes County
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Gyula, Bekes County, Ungarn, 5700
- Békés Vármegyei Központi Kórház
-
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Bács-Kiskun county
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Baja, Bács-Kiskun county, Ungarn, 6500
- Lausmed Kft.
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Kecskemét, Bács-Kiskun county, Ungarn, 6000
- KomplexLabor Diagnosztika Kft.
-
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Csongrád-Csanád
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Szeged, Csongrád-Csanád, Ungarn, 6725
- Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
-
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Szabolcs-Szatmár-Bereg
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Nyíregyháza, Szabolcs-Szatmár-Bereg, Ungarn, 4400
- Medifarma-98 Kft.
-
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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 assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes (T2D) above or equal to 180 days before screening.
- On stable daily dose(s) of metformin, sodium-glucose transport 2 (SGLT2) inhibitor, or both (at effective or maximum tolerated dose as judged by the investigator) prior to screening.
- Glycated haemoglobin (HbA1c) as determined by central laboratory at screening.
Exclusion Criteria:
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
- Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.
- Planned coronary, carotid or peripheral artery revascularisation.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria before screening. However, insulin treatment for gestational diabetes is allowed as well as short term insulin treatment for a maximum of 14 consecutive days.
- Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.
- Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening.
Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation.
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: Zenagamtide
Participants will receive zenagamtide subcutaneously once weekly |
Zenagamtide will be administered subcutaneously |
|
Aktiv komparator: Semaglutide
Participants will receive semaglutide subcutaneously once weekly |
Semaglutide will be administered subcutaneously |
|
Placebo komparator: Placebo
Participants will receive placebo matched to semaglutide or zenagamtide subcutaneously once weekly |
Placebo matched to semaglutide or zenagamtide will be administered subcutaneously |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in glycated haemoglobin (HbA1c) [non-inferiority]
Tidsramme: From baseline (week 0) to week 60
|
Measured in percentage point |
From baseline (week 0) to week 60
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Relative change in body weight
Tidsramme: From baseline (week 0) to week 60
|
Measured in percentage |
From baseline (week 0) to week 60
|
|
Change in glycated haemoglobin (HbA1c) [superiority]
Tidsramme: From baseline (week 0) to week 60
|
Measured in percentage point |
From baseline (week 0) to week 60
|
|
Change in triglycerides
Tidsramme: From baseline (week 0) to week 60
|
Measured in ratio to baseline |
From baseline (week 0) to week 60
|
|
Change in systolic blood pressure
Tidsramme: From baseline (week 0) to week 60
|
Measured in mmHg |
From baseline (week 0) to week 60
|
|
Change in non-high density lipoprotein (non-HDL) cholesterol
Tidsramme: From baseline (week 0) to week 60
|
Measured in ratio to baseline |
From baseline (week 0) to week 60
|
|
Change in high-sensitivity C-reactive protein (hsCRP)
Tidsramme: From baseline (week 0) to week 60
|
Measured in ratio to baseline |
From baseline (week 0) to week 60
|
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)
10. november 2026
Primær færdiggørelse (Anslået)
4. juli 2028
Studieafslutning (Anslået)
8. august 2028
Datoer for studieregistrering
Først indsendt
6. november 2026
Først indsendt, der opfyldte QC-kriterier
6. november 2026
Først opslået (Faktiske)
12. november 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. november 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NN9489-8035
- U1111-1335-3379 (Anden identifikator: World Health Organization (WHO))
- 2026-525472-26 (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 .