- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07931573
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)
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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: Novo Nordisk
- Numero di telefono: (+1) 866-867-7178
- Email: clinicaltrials@novonordisk.com
Luoghi di studio
-
-
-
Al Ahsa, Arabia Saudita, 36428
- National Guard- Alahsa
-
Jeddah, Arabia Saudita, 21423
- King Abdullah International Medical Research Center KAIMRC
-
Jeddah, Arabia Saudita, 21589
- King Fahd Medical Research Center-King Abdulaziz University
-
Khobar, Arabia Saudita, 34445
- King Fahad Hospital of the University
-
Riyadh, Arabia Saudita, 59046
- King Fahad Medical City
-
Riyadh, Arabia Saudita, 12372
- King Khaled University Hospital,King Saud Univ. Med. City
-
Riyadh, Arabia Saudita, 11481
- King Abdullah International Medical Research Center KAIMRC
-
Riyadh, Arabia Saudita, 11499
- King Faisal Specialist Hospital & Research Centre, Riyadh
-
Ulaishah, Riyadh, Arabia Saudita, 12746
- King Saud Medical City Hospital
-
-
-
-
-
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, Brasile, 80810-040
- Centro de Diabetes Curitiba
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasile, 90430-001
- Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
-
-
São Paulo
-
Campinas, São Paulo, Brasile, 13060-803
- PUCCAMP - Hospital e Maternidade Celso Pierro
-
São Paulo, São Paulo, Brasile, 05403-000
- Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP
-
São Paulo, São Paulo, Brasile, 01228-000
- CPQuali Pesquisa Clínica Ltda
-
São Paulo, São Paulo, Brasile, 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
-
-
-
-
-
Chrudim III, Cechia, 53701
- INTENDIA klinika s.r.o.
-
Hranice, Cechia, 753 01
- AIDIN VK s.r.o.
-
Olomouc, Cechia, 779 00
- Diabetologické centrum s.r.o.
-
Prague, Cechia, 110 00
- Diabet2 s.r.o.
-
Prague, Cechia, 150 00
- EUC Klinika Praha a.s.
-
Prague, Cechia, 10400
- ENDOTRIAL s.r.o.
-
Prague, Cechia, 149 00
- Milan Kvapil s.r.o.
-
Prague, Cechia, 160 00
- Fledip s.r.o.
-
-
-
-
-
Karlovac, Croazia, 47000
- Opca bolnica Karlovac_Endocrinology
-
Krapinske Toplice, Croazia, 49217
- Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
-
Osijek, Croazia, 31 000
- Klinicki bolnicki centar Osijek_Endocrinology
-
Rijeka, Croazia, 51 000
- Clinical Hospital Centre Rijeka_Endocrinology
-
Slavonski Brod, Croazia, 35 000
- General Hospital Dr. Josip Bencevic_Diabetic department
-
Solin, Croazia, 21210
- Poliklinika za oftalmologiju optometriju i neurologiju Lux
-
Zagreb, Croazia, 10000
- Poliklinika Solmed
-
-
-
-
-
Aarhus, Danimarca, 8200
- Aarhus Universitetshospital, Steno Diabetes Center Aarhus
-
Gandrup, Danimarca, 9362
- Sanos Clinic - Gandrup
-
Herlev, Danimarca, 2730
- Steno Diabetes Center Copenhagen
-
Odense C, Danimarca, 5000
- Steno Diabetes Center Odense
-
-
Region Sjælland
-
Køge, Region Sjælland, Danimarca, 4600
- Sjællands Universitetshospital, Køge - Medicinsk Afdeling
-
-
-
-
-
Bad Oeynhausen, Germania, 32545
- Herz- und Diabeteszentrum NRW - Bad Oeynhausen
-
Berlin, Germania, 13597
- Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
-
Duisburg, Germania, 47269
- MVZ Hausärzte Großenbaum GmbH Duisburg
-
Falkensee, Germania, 14612
- Zentrum für klinische Forschung, Dr. med. Lüdemann
-
Gladbeck, Germania, 45968
- Hausarztzentrum Butendorf
-
Hamburg, Germania, 22607
- Wendisch - Dahl Hamburg - DZHW
-
Köln-Dünnwald, Germania, 51069
- Zentrum für Klinische Forschung Köln-Dünnwald
-
Leipzig, Germania, 04249
- Gemeinschaftspraxis Dr. Täschner/Dr. Bonigut
-
Münster, Germania, 48153
- MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
-
Pirna, Germania, 01796
- Hausärztliche und Diabetologische Praxis Pirna
-
Pohlheim, Germania, 35415
- ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
-
Reinfeld, Germania, 23858
- Praxis Reinfeld Mitte
-
Villingen-Schwenningen, Germania, 78048
- Praxis für Prävention und Therapie, Drs Jacob
-
-
-
-
-
Athens, Grecia, 11527
- General Hospital Of Athens G Gennimatas - Department of Endocrinology
-
Chios, Grecia, 82131
- General Hospital of Chios "Skilitsio" - Internal Medicine Department
-
Goudi/Athens, Grecia, 11527
- "Laiko" General Hospital of Athens
-
Ioannina, Grecia, 455 00
- University General Hospital of Ioannina, Endocrinology Department and Diabetes Centre
-
Kalamata, Grecia, 24131
- City Hospital Kliniki Monoprosopi I.K.E. - Endocrinology Department
-
Larissa, Grecia, 41110
- University General Hospital of Larissa - Department of Endocrinology and Metabolic Diseases
-
Palaió Fáliro, Grecia, 17562
- Athens Medical Center S.A. (Iatriko P. Falirou) - Diabetes and Clinical Research Center
-
Thessaloniki, Grecia, 546 35
- General Hospital Of Thessaloniki G Gennimatas - Internal Medicine Clinic
-
Thessaloniki, Grecia, 57001
- Thermi Clinic S.A. - Diabetes and Internal Medicine Department
-
Thessaloniki, Grecia, 54635
- NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes
-
Thessaloniki, Grecia, 570 10
- Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department
-
-
-
-
-
Atlit, Israele, 30300
- Clalit HMO Atlit - Endocrinology Department
-
Beersheba, Israele, 84244
- Clalit HMO Beer Sheva - Endocrinology Department
-
Hadera, Israele, 3810101
- Hillel Yaffe MC - Endocrinology Department
-
Haifa, Israele, 35152
- Linn clinic - Diabetes Unit
-
Haifa, Israele, 6091000
- Bnai Zion MC - Department of Endocrinology
-
Holon, Israele, 58100
- Wolfson MC - Diabetes Clinic
-
Jerusalem, Israele, 9103102
- Shaare Zedek MC - Endocrinology Department
-
Majd el Kurūm, Israele, 1234567
- Clalit HMO Majd Al-Kurum - Endocrinology Department
-
Sakhnin, Israele, 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
-
-
-
-
-
Chojnice, Polonia, 89-600
- OptiTrial Sp. z o.o.
-
Lublin, Polonia, 20-607
- Reumed Sp. z o.o.
-
Piotrkow Trybunalski, Polonia, 97-300
- Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
-
Tarnów, Polonia, 33-100
- Metabolica Sp. z o.o.
-
Warsaw, Polonia, 00-710
- NBR Polska Tomasz Klodawski
-
Zabrze, Polonia, 41-800
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
-
-
Dolnosląskie
-
Wroclaw, Dolnosląskie, Polonia, 51-124
- Clinical Study Center S.C.
-
-
Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, Polonia, 15-435
- NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
-
-
-
-
-
San Juan, Porto Rico, 00907
- Solace Clinical Research
-
-
-
-
-
Almada, Portogallo, 2805-267
- ULS Almada-Seixal E.P.E. - HGO_Serviço de Endocrinologia
-
Braga, Portogallo, 4710-243
- ULS De Braga, E.P.E. - Hospital de Braga_Centro Clínico Académico
-
Coimbra, Portogallo, 3000-150
- Casa De Saúde De Santa Filomena S.A._Unidade de Ensaios Clínicos
-
Guarda, Portogallo, 6301-858
- ULS Da Guarda E.P.E. - Hospital Sousa Martins_Serviço de Medicina Interna
-
Guimarães, Portogallo, 4835-044
- ULS Do Alto Ave, E.P.E - HSOG_Centro de Investigação Clínica
-
Leiria, Portogallo, 2400-110
- Hospital São Francisco, S.A_EECC
-
Lisbon, Portogallo, 1449-005
- ULS Lisboa Ocidental, E.P.E_Hospital São Francisco Xavier_Hospital de Dia de Especialidades Médicas
-
Lisbon, Portogallo, 1350-345
- Hospital CUF Tejo, S.A._Serviço Endocrinologia
-
Ponte de Lima, Portogallo, 4990-029
- Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda
-
Porto, Portogallo, 4100-180
- CUF Porto_Serviço de Medicina Interna
-
Senhora Da Hora, Matosinhos, Portogallo, 4464-513
- ULS De Matosinhos, E.P.E - HPH_Serviço de Endocrinologia
-
Setúbal, Portogallo, 2900-722
- Hospital da Luz Setúbal, S.A._Serviço de Medicina Interna
-
Viseu, Portogallo, 3500-093
- Casa de Saúde de São Mateus, S.A.
-
-
-
-
-
Blackburn, Regno Unito, BB2 1AX
- Oakenhurst Medical Practice
-
Chippenham, Regno Unito, SN14 6GT
- Hathaway Medical Centre
-
London, Regno Unito, SW1P 2PF
- Healthcare Central London - South Westminster Centre for Health
-
Nantwich, Regno Unito, CW5 5NX
- Kiltearn Medical Centre
-
Rotherham, Regno Unito, S61 1AH
- Woodstock Bower Group Practice
-
Sandbach, Regno Unito, CW11 1EQ
- Ashfields Primary Care Centre
-
Swansea, Regno Unito, SA2 8PP
- Joint Clinical Research Facility - Swansea
-
-
Cornwall
-
Liskeard, Cornwall, Regno Unito, PL14 3XA
- Oak Tree Surgery
-
Truro, Cornwall, Regno Unito, TR1 3LJ
- Royal Cornwall Hospital (Treliske) - Diabetes
-
-
Devon
-
Torquay, Devon, Regno Unito, TQ1 4QX
- Brunel Medical Practice
-
-
Hertfordshire
-
Bushey, Hertfordshire, Regno Unito, WD23 2NN
- Attenborough Surgery
-
-
-
-
-
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
-
-
-
-
-
Bardejov, Slovacchia, 08501
- DIADA, s.r.o.
-
Košice, Slovacchia, 040 01
- HUMAN-CARE, s.r.o.
-
Martin, Slovacchia, 036 01
- DIAMARTIN, s. r. o.
-
Poprad, Slovacchia, 05801
- DENTAVIA s.r.o.
-
Spišská Nová Ves, Slovacchia, 052 01
- Diabetologicka ambulancia MUDr. Gabriela Zimova
-
Svidník, Slovacchia, 08901
- SIRCO 2, s. r. o.
-
-
-
-
-
Almería, Spagna, 04009
- Centro Periferico De Especialidades Bola Azul
-
Barcelona, Spagna, 08017
- CAP Sarrià
-
Barcelona, Spagna, 08023
- EBA Vallcarca SLP
-
Barcelona, Spagna, 08028
- CAPSBE_CAP Ernest LLuch
-
Barcelona, Spagna, 08360
- CAP Canet de Mar
-
Cabra, Spagna, 14940
- Centro de Salud Cabra Matrona Antonia Mesa
-
Castilleja de la Cuesta, Spagna, 41950
- Hospital Vithas Sevilla
-
La Cuesta (Santa Cruz de Tenerife), Spagna, 38320
- Centro de Salud La Cuesta
-
Pozuelo de Alarcón, Spagna, 28223
- Centro de Salud San Juan de la Cruz
-
Santander, Spagna, 39008
- H. Univ. Marqués de Valdecilla_Endocrinología
-
-
Barcelona
-
Sant Cugat del Vallès, Barcelona, Spagna, 08173
- CAP Turó de Can Mates
-
Vic, Barcelona, Spagna, 08500
- Equip D'assistencia Primaria Vic S.L.P.
-
-
-
-
Arizona
-
Phoenix, Arizona, Stati Uniti, 85016
- Rio Clinical Trials Arizona
-
-
California
-
La Jolla, California, Stati Uniti, 92037
- Scripps Whittier Diabetes Inst
-
La Mesa, California, Stati Uniti, 91942
- Diabetes & Endocrine Specialists - La Mesa
-
Lancaster, California, Stati Uniti, 93534
- First Valley Med Grp Lancaster
-
Los Angeles, California, Stati Uniti, 90015
- Los Angeles Institute for Metabolic Research
-
Northridge, California, Stati Uniti, 91325
- Valley Clinical Trials, Inc.
-
Palm Springs, California, Stati Uniti, 92262
- Desert Oasis Hlthcr Med Group
-
San Diego, California, Stati Uniti, 92111
- Linda Vista Health Care Ctr
-
Santa Ana, California, Stati Uniti, 92701
- Southern Cal Clinical Research
-
Spring Valley, California, Stati Uniti, 91978
- Encompass Clinical Research_Spring Valley
-
Walnut Creek, California, Stati Uniti, 94598
- Diablo Clinical Research, Inc.
-
-
Connecticut
-
Waterbury, Connecticut, Stati Uniti, 06708
- Chase Medical Research LLC
-
-
Florida
-
Hollywood, Florida, Stati Uniti, 33024
- Encore Medical Research LLC
-
Jacksonville, Florida, Stati Uniti, 32256
- University of Florida Cardiology
-
Miami, Florida, Stati Uniti, 33165
- New Horizon Research Center
-
Miami, Florida, Stati Uniti, 33155
- My Preferred Research
-
Miami, Florida, Stati Uniti, 33173
- GTL Med & Res Group
-
Miami Gardens, Florida, Stati Uniti, 33014
- Life Medical Research Group
-
Miramar, Florida, Stati Uniti, 33027
- South Broward Research LLC
-
Mt. Dora, Florida, Stati Uniti, 32757
- Adult Medicine of Lake County, Inc
-
Ocoee, Florida, Stati Uniti, 34761
- West Orange Endocrinology
-
Orlando, Florida, Stati Uniti, 32825
- Florida Institute for Clinical research
-
Tampa, Florida, Stati Uniti, 36607
- True Blue Clinical Research
-
Weston, Florida, Stati Uniti, 33331
- Encore Medical Research of Weston
-
-
Idaho
-
Meridian, Idaho, Stati Uniti, 83646
- Solaris Clinical Research
-
-
Illinois
-
Gurnee, Illinois, Stati Uniti, 60031
- Clinical Invest Special_Gurnee
-
-
Kansas
-
Topeka, Kansas, Stati Uniti, 66606
- Cotton O'Neil Diab & Endo Ctr
-
-
Maryland
-
Olney, Maryland, Stati Uniti, 20832
- MedStar Health Research Institute
-
Rockville, Maryland, Stati Uniti, 20852
- Endo And Metab Cons
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02115
- Brigham & Women's Hospital
-
-
Michigan
-
Flint, Michigan, Stati Uniti, 48532
- Elite Clinical Research
-
-
Missouri
-
City of Saint Peters, Missouri, Stati Uniti, 63303
- StudyMetrix Research LLC
-
-
Nevada
-
Las Vegas, Nevada, Stati Uniti, 89148
- Palm Research Center Inc-Vegas
-
-
New Hampshire
-
Nashua, New Hampshire, Stati Uniti, 03060
- Southern NH Diabetes and Endo_Nashua
-
-
New York
-
Albany, New York, Stati Uniti, 12203
- AMC Community Endocrinology
-
West Seneca, New York, Stati Uniti, 14224
- Southgate Medical Group, LLP
-
-
North Carolina
-
Greensboro, North Carolina, Stati Uniti, 27408
- PharmQuest Life Sciences LLC
-
Monroe, North Carolina, Stati Uniti, 28112
- Monroe Biomedical Research, LLC
-
Wilmington, North Carolina, Stati Uniti, 28401
- Accellacare
-
-
Ohio
-
Canton, Ohio, Stati Uniti, 44718
- Diab & Endo Assoc of Stark Co
-
-
South Carolina
-
Charleston, South Carolina, Stati Uniti, 29407
- DelRicht Research at Newton Family Medicine
-
Spartanburg, South Carolina, Stati Uniti, 29303
- Spartanburg Medical Research
-
-
South Dakota
-
Sioux Falls, South Dakota, Stati Uniti, 57104
- South Dakota Urban Indian Health
-
-
Tennessee
-
Bristol, Tennessee, Stati Uniti, 37620-7352
- Holston Medical Group Pc
-
Kingsport, Tennessee, Stati Uniti, 37660
- Holston Medical Group
-
Nashville, Tennessee, Stati Uniti, 37203
- Clinical Research Associates
-
-
Texas
-
Houston, Texas, Stati Uniti, 77074
- Southwest Clinical Trials
-
Houston, Texas, Stati Uniti, 77024
- Victorium Clinical Research
-
Katy, Texas, Stati Uniti, 77450
- Medical Colleagues-Texas LLP
-
San Antonio, Texas, Stati Uniti, 78233
- NE Clin Res of San Antonio
-
San Antonio, Texas, Stati Uniti, 78222
- Pinnacle Clinical Research
-
Shavano Park, Texas, Stati Uniti, 78231
- Consano Clinical Research, LLC
-
Weslaco, Texas, Stati Uniti, 78596
- Texas Valley Clinical Research
-
-
Utah
-
Sandy City, Utah, Stati Uniti, 84093
- Diabetes & Endo Treatment Spec
-
-
Washington
-
Renton, Washington, Stati Uniti, 98057
- Rainier Clin Res Ctr Inc
-
-
-
-
-
Balatonfüred, Ungheria, 8230
- DRC Kft.
-
Békéscsaba, Ungheria, 5600
- Trial Pharma Kft.
-
Kaposvár, Ungheria, 7400
- Somogy Vármegyei Kaposi Mór Oktató Kórház
-
-
Bekes County
-
Gyula, Bekes County, Ungheria, 5700
- Békés Vármegyei Központi Kórház
-
-
Bács-Kiskun county
-
Baja, Bács-Kiskun county, Ungheria, 6500
- Lausmed Kft.
-
Kecskemét, Bács-Kiskun county, Ungheria, 6000
- KomplexLabor Diagnosztika Kft.
-
-
Csongrád-Csanád
-
Szeged, Csongrád-Csanád, Ungheria, 6725
- Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
-
-
Szabolcs-Szatmár-Bereg
-
Nyíregyháza, Szabolcs-Szatmár-Bereg, Ungheria, 4400
- Medifarma-98 Kft.
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Zenagamtide
Participants will receive zenagamtide subcutaneously once weekly |
Zenagamtide will be administered subcutaneously |
|
Comparatore attivo: Semaglutide
Participants will receive semaglutide subcutaneously once weekly |
Semaglutide will be administered subcutaneously |
|
Comparatore placebo: Placebo
Participants will receive placebo matched to semaglutide or zenagamtide subcutaneously once weekly |
Placebo matched to semaglutide or zenagamtide will be administered subcutaneously |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in glycated haemoglobin (HbA1c) [non-inferiority]
Lasso di tempo: From baseline (week 0) to week 60
|
Measured in percentage point |
From baseline (week 0) to week 60
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Relative change in body weight
Lasso di tempo: From baseline (week 0) to week 60
|
Measured in percentage |
From baseline (week 0) to week 60
|
|
Change in glycated haemoglobin (HbA1c) [superiority]
Lasso di tempo: From baseline (week 0) to week 60
|
Measured in percentage point |
From baseline (week 0) to week 60
|
|
Change in triglycerides
Lasso di tempo: From baseline (week 0) to week 60
|
Measured in ratio to baseline |
From baseline (week 0) to week 60
|
|
Change in systolic blood pressure
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: From baseline (week 0) to week 60
|
Measured in ratio to baseline |
From baseline (week 0) to week 60
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NN9489-8035
- U1111-1335-3379 (Altro identificatore: World Health Organization (WHO))
- 2026-525472-26 (Altro identificatore: European Medical Agency (EMA))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .