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 oppdatert av: 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).
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
1200
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-post: clinicaltrials@novonordisk.com
Studiesteder
-
-
-
Buenos Aires, Argentina, C1015
- OMI- Organización Médica de Investigación
-
San Nicolás, Argentina, B2900
- Instituto de Investigaciones Clinicas San Nicolás
-
Santa Fe, Argentina, S3000FSO
- CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
-
Santa Fe, Argentina, S2152BOF
- Centro de Investigaciones Clinica Baigorria
-
-
Buenos Aires
-
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1424CIQ
- CICEMO- Consultorio (Av Directorio)
-
Mar del Plata, Buenos Aires, Argentina, B7600FZN
- Instituto de Investigaciones Clinicas Mar Del Plata
-
-
Santa Fe Province
-
Rafaela, Santa Fe Province, Argentina, S2300
- Mains Bleues SA
-
-
-
-
New South Wales
-
Castle Hill, New South Wales, Australia, 2154
- Castle Hill Medical Centre
-
Macquarie Park, New South Wales, Australia, 2109
- Macquarie University - Clinical Trials Unit
-
-
Queensland
-
Douglass, Queensland, Australia, 4814
- Townsville University Hospital - Diabetes and Endocrine Department
-
Meadowbrook, Queensland, Australia, 4131
- Logan Hospital
-
Toowoomba, Queensland, Australia, 4350
- Regional Research Institute
-
-
Victoria
-
Clayton, Victoria, Australia, 3168
- Monash Medical Centre - Bone and Muscle Research Group
-
Parkville, Victoria, Australia, 3050
- The Royal Melbourne Hospital - Diabetes & Endocrinology Department
-
Torquay, Victoria, Australia, 3228
- Clinical Trials Institute
-
-
-
-
Paraná
-
Curitiba, Paraná, Brasil, 80810-040
- Centro de Diabetes Curitiba
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasil, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
-
-
São Paulo
-
Campinas, São Paulo, Brasil, 13060-803
- PUCCAMP - Hospital e Maternidade Celso Pierro
-
São Paulo, São Paulo, Brasil, 05403-000
- Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP
-
São Paulo, São Paulo, Brasil, 01228-000
- CPQuali Pesquisa Clínica Ltda
-
São Paulo, São Paulo, Brasil, 01228-200
- CPCLIN - Centro de Pesquisas Clínicas
-
-
-
-
-
Gabrovo, Bulgaria, 5312
- Medical Center New Polyclinic Gabrovo OOD
-
Rousse, Bulgaria, 7002
- UMHAT Kanev AD, Second Department of Internal Diseases
-
Sliven, Bulgaria, 8800
- MHAT Dr. Ivan Seliminski - Sliven AD
-
Smolyan, Bulgaria, 4700
- Medical center Smolyan clinical research OOD
-
Sofia, Bulgaria, 1527
- MC Orthopaedic Center Kinov EOOD
-
Sofia, Bulgaria, 1431
- UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases
-
Sofia, Bulgaria, 1582
- Medical centre Druzhba EOOD
-
Sofia, Bulgaria, 1616
- Medical Center - Sveti Dimitar EOOD
-
Varna, Bulgaria, 9000
- Medical center Higiya OOD
-
-
-
-
-
Québec, Canada, G1V 4W2
- Clinique des Maladies Lipidiques de Quebec Inc.
-
-
British Columbia
-
Surrey, British Columbia, Canada, V4A 0C1
- Hilltop Medical Clinic
-
Surrey, British Columbia, Canada, V3T0X6
- TLC Diabetes and Endocrinology
-
-
New Brunswick
-
Moncton, New Brunswick, Canada, E1G 1A7
- G.A. Research Associates Ltd.
-
-
Ontario
-
Brampton, Ontario, Canada, L6S 0C6
- Centricity Research Brampton Endocrinology
-
Etobicoke, Ontario, Canada, M9R 4E1
- Centricity Research Etobicoke Endocrinology
-
-
Quebec
-
Montreal, Quebec, Canada, H4N 2W2
- Centre Medical Acadie
-
-
-
-
-
Aarhus, Danmark, 8200
- Aarhus Universitetshospital, Steno Diabetes Center Aarhus
-
Gandrup, Danmark, 9362
- Sanos Clinic - Gandrup
-
Herlev, Danmark, 2730
- Steno Diabetes Center Copenhagen
-
Odense C, Danmark, 5000
- Steno Diabetes Center Odense
-
-
Region Sjælland
-
Køge, Region Sjælland, Danmark, 4600
- Sjællands Universitetshospital, Køge - Medicinsk Afdeling
-
-
-
-
Arizona
-
Phoenix, Arizona, Forente stater, 85016
- Rio Clinical Trials Arizona
-
-
California
-
La Jolla, California, Forente stater, 92037
- Scripps Whittier Diabetes Inst
-
La Mesa, California, Forente stater, 91942
- Diabetes & Endocrine Specialists - La Mesa
-
Lancaster, California, Forente stater, 93534
- First Valley Med Grp Lancaster
-
Los Angeles, California, Forente stater, 90015
- Los Angeles Institute for Metabolic Research
-
Northridge, California, Forente stater, 91325
- Valley Clinical Trials, Inc.
-
Palm Springs, California, Forente stater, 92262
- Desert Oasis Hlthcr Med Group
-
San Diego, California, Forente stater, 92111
- Linda Vista Health Care Ctr
-
Santa Ana, California, Forente stater, 92701
- Southern Cal Clinical Research
-
Spring Valley, California, Forente stater, 91978
- Encompass Clinical Research_Spring Valley
-
Walnut Creek, California, Forente stater, 94598
- Diablo Clinical Research, Inc.
-
-
Connecticut
-
Waterbury, Connecticut, Forente stater, 06708
- Chase Medical Research LLC
-
-
Florida
-
Hollywood, Florida, Forente stater, 33024
- Encore Medical Research LLC
-
Jacksonville, Florida, Forente stater, 32256
- University of Florida Cardiology
-
Miami, Florida, Forente stater, 33165
- New Horizon Research Center
-
Miami, Florida, Forente stater, 33155
- My Preferred Research
-
Miami, Florida, Forente stater, 33173
- GTL Med & Res Group
-
Miami Gardens, Florida, Forente stater, 33014
- Life Medical Research Group
-
Miramar, Florida, Forente stater, 33027
- South Broward Research LLC
-
Mt. Dora, Florida, Forente stater, 32757
- Adult Medicine of Lake County, Inc
-
Ocoee, Florida, Forente stater, 34761
- West Orange Endocrinology
-
Orlando, Florida, Forente stater, 32825
- Florida Institute for Clinical research
-
Tampa, Florida, Forente stater, 36607
- True Blue Clinical Research
-
Weston, Florida, Forente stater, 33331
- Encore Medical Research of Weston
-
-
Idaho
-
Meridian, Idaho, Forente stater, 83646
- Solaris Clinical Research
-
-
Illinois
-
Gurnee, Illinois, Forente stater, 60031
- Clinical Invest Special_Gurnee
-
-
Kansas
-
Topeka, Kansas, Forente stater, 66606
- Cotton O'Neil Diab & Endo Ctr
-
-
Maryland
-
Olney, Maryland, Forente stater, 20832
- MedStar Health Research Institute
-
Rockville, Maryland, Forente stater, 20852
- Endo And Metab Cons
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02115
- Brigham & Women's Hospital
-
-
Michigan
-
Flint, Michigan, Forente stater, 48532
- Elite Clinical Research
-
-
Missouri
-
City of Saint Peters, Missouri, Forente stater, 63303
- StudyMetrix Research LLC
-
-
Nevada
-
Las Vegas, Nevada, Forente stater, 89148
- Palm Research Center Inc-Vegas
-
-
New Hampshire
-
Nashua, New Hampshire, Forente stater, 03060
- Southern NH Diabetes and Endo_Nashua
-
-
New York
-
Albany, New York, Forente stater, 12203
- AMC Community Endocrinology
-
West Seneca, New York, Forente stater, 14224
- Southgate Medical Group, LLP
-
-
North Carolina
-
Greensboro, North Carolina, Forente stater, 27408
- PharmQuest Life Sciences LLC
-
Monroe, North Carolina, Forente stater, 28112
- Monroe Biomedical Research, LLC
-
Wilmington, North Carolina, Forente stater, 28401
- Accellacare
-
-
Ohio
-
Canton, Ohio, Forente stater, 44718
- Diab & Endo Assoc of Stark Co
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29407
- DelRicht Research at Newton Family Medicine
-
Spartanburg, South Carolina, Forente stater, 29303
- Spartanburg Medical Research
-
-
South Dakota
-
Sioux Falls, South Dakota, Forente stater, 57104
- South Dakota Urban Indian Health
-
-
Tennessee
-
Bristol, Tennessee, Forente stater, 37620-7352
- Holston Medical Group Pc
-
Kingsport, Tennessee, Forente stater, 37660
- Holston Medical Group
-
Nashville, Tennessee, Forente stater, 37203
- Clinical Research Associates
-
-
Texas
-
Houston, Texas, Forente stater, 77074
- Southwest Clinical Trials
-
Houston, Texas, Forente stater, 77024
- Victorium Clinical Research
-
Katy, Texas, Forente stater, 77450
- Medical Colleagues-Texas LLP
-
San Antonio, Texas, Forente stater, 78233
- NE Clin Res of San Antonio
-
San Antonio, Texas, Forente stater, 78222
- Pinnacle Clinical Research
-
Shavano Park, Texas, Forente stater, 78231
- Consano Clinical Research, LLC
-
Weslaco, Texas, Forente stater, 78596
- Texas Valley Clinical Research
-
-
Utah
-
Sandy City, Utah, Forente stater, 84093
- Diabetes & Endo Treatment Spec
-
-
Washington
-
Renton, Washington, Forente stater, 98057
- Rainier Clin Res Ctr Inc
-
-
-
-
-
Athens, Hellas, 11527
- General Hospital Of Athens G Gennimatas - Department of Endocrinology
-
Chios, Hellas, 82131
- General Hospital of Chios "Skilitsio" - Internal Medicine Department
-
Goudi/Athens, Hellas, 11527
- "Laiko" General Hospital of Athens
-
Ioannina, Hellas, 455 00
- University General Hospital of Ioannina, Endocrinology Department and Diabetes Centre
-
Kalamata, Hellas, 24131
- City Hospital Kliniki Monoprosopi I.K.E. - Endocrinology Department
-
Larissa, Hellas, 41110
- University General Hospital of Larissa - Department of Endocrinology and Metabolic Diseases
-
Palaió Fáliro, Hellas, 17562
- Athens Medical Center S.A. (Iatriko P. Falirou) - Diabetes and Clinical Research Center
-
Thessaloniki, Hellas, 546 35
- General Hospital Of Thessaloniki G Gennimatas - Internal Medicine Clinic
-
Thessaloniki, Hellas, 57001
- Thermi Clinic S.A. - Diabetes and Internal Medicine Department
-
Thessaloniki, Hellas, 54635
- NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes
-
Thessaloniki, Hellas, 570 10
- Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department
-
-
-
-
-
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
-
-
-
-
-
Roma, Italia, 00161
- Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale
-
Rozzano (MI), Italia, 20089
- IRCCS Humanitas - U.O. Endocrinologia e Diabetologia
-
-
Apulia
-
Acquaviva delle Fonti, Apulia, Italia, 70021
- Ente Ecclesiastico Ospedale Generale Regionale Miulli - Endocrinologia
-
Bari, Apulia, Italia, 70124
- AOU Consorziale Policlinico Bari - U.O.C. Endocrinologia Universitaria
-
-
Emilia-Romagna
-
Parma, Emilia-Romagna, Italia, 43126
- Azienda Ospedaliera - Universitaria Parma - UOC di Endocrinologia e Malattie del Metabolismo
-
Ravenna, Emilia-Romagna, Italia, 48121
- AUSL Romagna - Distretto di Ravenna - Ospedale Santa Maria delle Croci
-
-
Lombardy
-
Milan, Lombardy, Italia, 20157
- ASST Fatebenefratelli Ospedale Luigi Sacco - Malattie Endocrine e Diabetologia
-
-
Tuscany
-
Florence, Tuscany, Italia, 50134
- Azienda Ospedaliero Universitaria Careggi - Diabetologia e malattie del metabolismo
-
-
Umbria
-
Perugia, Umbria, Italia, 06129
- A.O.S. Maria della Misericordia - Dipartimento di Medicina Generale e Specialistica
-
-
-
-
-
Karlovac, Kroatia, 47000
- Opca bolnica Karlovac_Endocrinology
-
Krapinske Toplice, Kroatia, 49217
- Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
-
Osijek, Kroatia, 31 000
- Klinicki bolnicki centar Osijek_Endocrinology
-
Rijeka, Kroatia, 51 000
- Clinical Hospital Centre Rijeka_Endocrinology
-
Slavonski Brod, Kroatia, 35 000
- General Hospital Dr. Josip Bencevic_Diabetic department
-
Solin, Kroatia, 21210
- Poliklinika za oftalmologiju optometriju i neurologiju Lux
-
Zagreb, Kroatia, 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
-
-
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, Romania, 500260
- Diabet Center SRL
-
Paşcani, Romania, 705200
- Bella Praxis S.R.L.
-
Piteşti, Romania, 110017
- Medis Muntenia SRL
-
-
Bihor County
-
Oradea, Bihor County, Romania, 410159
- Grandmed SRL
-
-
Bucharest
-
Bucharest, Bucharest, Romania, 020475
- Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
-
-
Maramureş
-
Baia Mare, Maramureş, Romania, 430222
- CMI Dr Pop Lavinia
-
-
Prahova
-
Ploieşti, Prahova, Romania, 100179
- Diabmed Dr Popescu Alexandrina SRL
-
Ploieşti, Prahova, Romania, 100342
- CMI Dr. Busegeanu Mihaela Magdalena
-
-
-
-
-
Al Ahsa, Saudi-Arabia, 36428
- National Guard- Alahsa
-
Jeddah, Saudi-Arabia, 21423
- King Abdullah International Medical Research Center KAIMRC
-
Jeddah, Saudi-Arabia, 21589
- King Fahd Medical Research Center-King Abdulaziz University
-
Khobar, Saudi-Arabia, 34445
- King Fahad Hospital of the University
-
Riyadh, Saudi-Arabia, 59046
- King Fahad Medical City
-
Riyadh, Saudi-Arabia, 12372
- King Khaled University Hospital,King Saud Univ. Med. City
-
Riyadh, Saudi-Arabia, 11481
- King Abdullah International Medical Research Center KAIMRC
-
Riyadh, Saudi-Arabia, 11499
- King Faisal Specialist Hospital & Research Centre, Riyadh
-
Ulaishah, Riyadh, Saudi-Arabia, 12746
- King Saud Medical City Hospital
-
-
-
-
-
Bardejov, Slovakia, 08501
- DIADA, s.r.o.
-
Košice, Slovakia, 040 01
- HUMAN-CARE, s.r.o.
-
Martin, Slovakia, 036 01
- DIAMARTIN, s. r. o.
-
Poprad, Slovakia, 05801
- DENTAVIA s.r.o.
-
Spišská Nová Ves, Slovakia, 052 01
- Diabetologicka ambulancia MUDr. Gabriela Zimova
-
Svidník, Slovakia, 08901
- SIRCO 2, s. r. o.
-
-
-
-
-
Almería, Spania, 04009
- Centro Periferico De Especialidades Bola Azul
-
Barcelona, Spania, 08017
- CAP Sarrià
-
Barcelona, Spania, 08023
- EBA Vallcarca SLP
-
Barcelona, Spania, 08028
- CAPSBE_CAP Ernest LLuch
-
Barcelona, Spania, 08360
- CAP Canet de Mar
-
Cabra, Spania, 14940
- Centro de Salud Cabra Matrona Antonia Mesa
-
Castilleja de la Cuesta, Spania, 41950
- Hospital Vithas Sevilla
-
La Cuesta (Santa Cruz de Tenerife), Spania, 38320
- Centro de Salud La Cuesta
-
Pozuelo de Alarcón, Spania, 28223
- Centro de Salud San Juan de la Cruz
-
Santander, Spania, 39008
- H. Univ. Marqués de Valdecilla_Endocrinología
-
-
Barcelona
-
Sant Cugat del Vallès, Barcelona, Spania, 08173
- CAP Turó de Can Mates
-
Vic, Barcelona, Spania, 08500
- Equip D'assistencia Primaria Vic S.L.P.
-
-
-
-
-
Blackburn, Storbritannia, BB2 1AX
- Oakenhurst Medical Practice
-
Chippenham, Storbritannia, SN14 6GT
- Hathaway Medical Centre
-
London, Storbritannia, SW1P 2PF
- Healthcare Central London - South Westminster Centre for Health
-
Nantwich, Storbritannia, CW5 5NX
- Kiltearn Medical Centre
-
Rotherham, Storbritannia, S61 1AH
- Woodstock Bower Group Practice
-
Sandbach, Storbritannia, CW11 1EQ
- Ashfields Primary Care Centre
-
Swansea, Storbritannia, SA2 8PP
- Joint Clinical Research Facility - Swansea
-
-
Cornwall
-
Liskeard, Cornwall, Storbritannia, PL14 3XA
- Oak Tree Surgery
-
Truro, Cornwall, Storbritannia, TR1 3LJ
- Royal Cornwall Hospital (Treliske) - Diabetes
-
-
Devon
-
Torquay, Devon, Storbritannia, TQ1 4QX
- Brunel Medical Practice
-
-
Hertfordshire
-
Bushey, Hertfordshire, Storbritannia, WD23 2NN
- Attenborough Surgery
-
-
-
-
-
Chrudim III, Tsjekkia, 53701
- INTENDIA klinika s.r.o.
-
Hranice, Tsjekkia, 753 01
- AIDIN VK s.r.o.
-
Olomouc, Tsjekkia, 779 00
- Diabetologické centrum s.r.o.
-
Prague, Tsjekkia, 110 00
- Diabet2 s.r.o.
-
Prague, Tsjekkia, 150 00
- EUC Klinika Praha a.s.
-
Prague, Tsjekkia, 10400
- ENDOTRIAL s.r.o.
-
Prague, Tsjekkia, 149 00
- Milan Kvapil s.r.o.
-
Prague, Tsjekkia, 160 00
- Fledip s.r.o.
-
-
-
-
-
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
-
Reinfeld, Tyskland, 23858
- Praxis Reinfeld Mitte
-
Villingen-Schwenningen, Tyskland, 78048
- Praxis für Prävention und Therapie, Drs Jacob
-
-
-
-
-
Balatonfüred, Ungarn, 8230
- DRC Kft.
-
Békéscsaba, Ungarn, 5600
- Trial Pharma Kft.
-
Kaposvár, Ungarn, 7400
- Somogy Vármegyei Kaposi Mór Oktató Kórház
-
-
Bekes County
-
Gyula, Bekes County, Ungarn, 5700
- Békés Vármegyei Központi Kórház
-
-
Bács-Kiskun county
-
Baja, Bács-Kiskun county, Ungarn, 6500
- Lausmed Kft.
-
Kecskemét, Bács-Kiskun county, Ungarn, 6000
- KomplexLabor Diagnosztika Kft.
-
-
Csongrád-Csanád
-
Szeged, Csongrád-Csanád, Ungarn, 6725
- Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
-
-
Szabolcs-Szatmár-Bereg
-
Nyíregyháza, Szabolcs-Szatmár-Bereg, Ungarn, 4400
- Medifarma-98 Kft.
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
10. november 2026
Primær fullføring (Antatt)
4. juli 2028
Studiet fullført (Antatt)
8. august 2028
Datoer for studieregistrering
Først innsendt
6. november 2026
Først innsendt som oppfylte QC-kriteriene
6. november 2026
Først lagt ut (Faktiske)
12. november 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. november 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NN9489-8035
- U1111-1335-3379 (Annen identifikator: World Health Organization (WHO))
- 2026-525472-26 (Annen identifikator: European Medical Agency (EMA))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .