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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)

2026年11月6日 更新者: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).

研究概览

研究类型

介入性

注册 (估计的)

1200

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Aarhus、丹麦、8200
        • Aarhus Universitetshospital, Steno Diabetes Center Aarhus
      • Gandrup、丹麦、9362
        • Sanos Clinic - Gandrup
      • Herlev、丹麦、2730
        • Steno Diabetes Center Copenhagen
      • Odense C、丹麦、5000
        • Steno Diabetes Center Odense
    • Region Sjælland
      • Køge、Region Sjælland、丹麦、4600
        • Sjællands Universitetshospital, Køge - Medicinsk Afdeling
      • Atlit、以色列、30300
        • Clalit HMO Atlit - Endocrinology Department
      • Beersheba、以色列、84244
        • Clalit HMO Beer Sheva - Endocrinology Department
      • Hadera、以色列、3810101
        • Hillel Yaffe MC - Endocrinology Department
      • Haifa、以色列、35152
        • Linn clinic - Diabetes Unit
      • Haifa、以色列、6091000
        • Bnai Zion MC - Department of Endocrinology
      • Holon、以色列、58100
        • Wolfson MC - Diabetes Clinic
      • Jerusalem、以色列、9103102
        • Shaare Zedek MC - Endocrinology Department
      • Majd el Kurūm、以色列、1234567
        • Clalit HMO Majd Al-Kurum - Endocrinology Department
      • Sakhnin、以色列、30810
        • Clalit HMO Sakhnin - Endocrinology Department
      • Gabrovo、保加利亚、5312
        • Medical Center New Polyclinic Gabrovo OOD
      • Rousse、保加利亚、7002
        • UMHAT Kanev AD, Second Department of Internal Diseases
      • Sliven、保加利亚、8800
        • MHAT Dr. Ivan Seliminski - Sliven AD
      • Smolyan、保加利亚、4700
        • Medical center Smolyan clinical research OOD
      • Sofia、保加利亚、1527
        • MC Orthopaedic Center Kinov EOOD
      • Sofia、保加利亚、1431
        • UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases
      • Sofia、保加利亚、1582
        • Medical centre Druzhba EOOD
      • Sofia、保加利亚、1616
        • Medical Center - Sveti Dimitar EOOD
      • Varna、保加利亚、9000
        • Medical center Higiya OOD
      • Karlovac、克罗地亚、47000
        • Opca bolnica Karlovac_Endocrinology
      • Krapinske Toplice、克罗地亚、49217
        • Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
      • Osijek、克罗地亚、31 000
        • Klinicki bolnicki centar Osijek_Endocrinology
      • Rijeka、克罗地亚、51 000
        • Clinical Hospital Centre Rijeka_Endocrinology
      • Slavonski Brod、克罗地亚、35 000
        • General Hospital Dr. Josip Bencevic_Diabetic department
      • Solin、克罗地亚、21210
        • Poliklinika za oftalmologiju optometriju i neurologiju Lux
      • Zagreb、克罗地亚、10000
        • Poliklinika Solmed
      • Québec、加拿大、G1V 4W2
        • Clinique des Maladies Lipidiques de Quebec Inc.
    • British Columbia
      • Surrey、British Columbia、加拿大、V4A 0C1
        • Hilltop Medical Clinic
      • Surrey、British Columbia、加拿大、V3T0X6
        • TLC Diabetes and Endocrinology
    • New Brunswick
      • Moncton、New Brunswick、加拿大、E1G 1A7
        • G.A. Research Associates Ltd.
    • Ontario
      • Brampton、Ontario、加拿大、L6S 0C6
        • Centricity Research Brampton Endocrinology
      • Etobicoke、Ontario、加拿大、M9R 4E1
        • Centricity Research Etobicoke Endocrinology
    • Quebec
      • Montreal、Quebec、加拿大、H4N 2W2
        • Centre Medical Acadie
      • Balatonfüred、匈牙利、8230
        • DRC Kft.
      • Békéscsaba、匈牙利、5600
        • Trial Pharma Kft.
      • Kaposvár、匈牙利、7400
        • Somogy Vármegyei Kaposi Mór Oktató Kórház
    • Bekes County
      • Gyula、Bekes County、匈牙利、5700
        • Békés Vármegyei Központi Kórház
    • Bács-Kiskun county
      • Baja、Bács-Kiskun county、匈牙利、6500
        • Lausmed Kft.
      • Kecskemét、Bács-Kiskun county、匈牙利、6000
        • KomplexLabor Diagnosztika Kft.
    • Csongrád-Csanád
      • Szeged、Csongrád-Csanád、匈牙利、6725
        • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza、Szabolcs-Szatmár-Bereg、匈牙利、4400
        • Medifarma-98 Kft.
    • Paraná
      • Curitiba、Paraná、巴西、80810-040
        • Centro de Diabetes Curitiba
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90430-001
        • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
    • São Paulo
      • Campinas、São Paulo、巴西、13060-803
        • PUCCAMP - Hospital e Maternidade Celso Pierro
      • São Paulo、São Paulo、巴西、05403-000
        • Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP
      • São Paulo、São Paulo、巴西、01228-000
        • CPQuali Pesquisa Clínica Ltda
      • São Paulo、São Paulo、巴西、01228-200
        • CPCLIN - Centro de Pesquisas Clínicas
      • Athens、希腊、11527
        • General Hospital Of Athens G Gennimatas - Department of Endocrinology
      • Chios、希腊、82131
        • General Hospital of Chios "Skilitsio" - Internal Medicine Department
      • Goudi/Athens、希腊、11527
        • "Laiko" General Hospital of Athens
      • Ioannina、希腊、455 00
        • University General Hospital of Ioannina, Endocrinology Department and Diabetes Centre
      • Kalamata、希腊、24131
        • City Hospital Kliniki Monoprosopi I.K.E. - Endocrinology Department
      • Larissa、希腊、41110
        • University General Hospital of Larissa - Department of Endocrinology and Metabolic Diseases
      • Palaió Fáliro、希腊、17562
        • Athens Medical Center S.A. (Iatriko P. Falirou) - Diabetes and Clinical Research Center
      • Thessaloniki、希腊、546 35
        • General Hospital Of Thessaloniki G Gennimatas - Internal Medicine Clinic
      • Thessaloniki、希腊、57001
        • Thermi Clinic S.A. - Diabetes and Internal Medicine Department
      • Thessaloniki、希腊、54635
        • NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes
      • Thessaloniki、希腊、570 10
        • Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department
      • Bad Oeynhausen、德国、32545
        • Herz- und Diabeteszentrum NRW - Bad Oeynhausen
      • Berlin、德国、13597
        • Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
      • Duisburg、德国、47269
        • MVZ Hausärzte Großenbaum GmbH Duisburg
      • Falkensee、德国、14612
        • Zentrum für klinische Forschung, Dr. med. Lüdemann
      • Gladbeck、德国、45968
        • Hausarztzentrum Butendorf
      • Hamburg、德国、22607
        • Wendisch - Dahl Hamburg - DZHW
      • Köln-Dünnwald、德国、51069
        • Zentrum für Klinische Forschung Köln-Dünnwald
      • Leipzig、德国、04249
        • Gemeinschaftspraxis Dr. Täschner/Dr. Bonigut
      • Münster、德国、48153
        • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
      • Pirna、德国、01796
        • Hausärztliche und Diabetologische Praxis Pirna
      • Pohlheim、德国、35415
        • ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
      • Reinfeld、德国、23858
        • Praxis Reinfeld Mitte
      • Villingen-Schwenningen、德国、78048
        • Praxis für Prävention und Therapie, Drs Jacob
      • Roma、意大利、00161
        • Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale
      • Rozzano (MI)、意大利、20089
        • IRCCS Humanitas - U.O. Endocrinologia e Diabetologia
    • Apulia
      • Acquaviva delle Fonti、Apulia、意大利、70021
        • Ente Ecclesiastico Ospedale Generale Regionale Miulli - Endocrinologia
      • Bari、Apulia、意大利、70124
        • AOU Consorziale Policlinico Bari - U.O.C. Endocrinologia Universitaria
    • Emilia-Romagna
      • Parma、Emilia-Romagna、意大利、43126
        • Azienda Ospedaliera - Universitaria Parma - UOC di Endocrinologia e Malattie del Metabolismo
      • Ravenna、Emilia-Romagna、意大利、48121
        • AUSL Romagna - Distretto di Ravenna - Ospedale Santa Maria delle Croci
    • Lombardy
      • Milan、Lombardy、意大利、20157
        • ASST Fatebenefratelli Ospedale Luigi Sacco - Malattie Endocrine e Diabetologia
    • Tuscany
      • Florence、Tuscany、意大利、50134
        • Azienda Ospedaliero Universitaria Careggi - Diabetologia e malattie del metabolismo
    • Umbria
      • Perugia、Umbria、意大利、06129
        • A.O.S. Maria della Misericordia - Dipartimento di Medicina Generale e Specialistica
      • Chrudim III、捷克语、53701
        • INTENDIA klinika s.r.o.
      • Hranice、捷克语、753 01
        • AIDIN VK s.r.o.
      • Olomouc、捷克语、779 00
        • Diabetologické centrum s.r.o.
      • Prague、捷克语、110 00
        • Diabet2 s.r.o.
      • Prague、捷克语、150 00
        • EUC Klinika Praha a.s.
      • Prague、捷克语、10400
        • ENDOTRIAL s.r.o.
      • Prague、捷克语、149 00
        • Milan Kvapil s.r.o.
      • Prague、捷克语、160 00
        • Fledip s.r.o.
      • Bardejov、斯洛伐克、08501
        • DIADA, s.r.o.
      • Košice、斯洛伐克、040 01
        • HUMAN-CARE, s.r.o.
      • Martin、斯洛伐克、036 01
        • DIAMARTIN, s. r. o.
      • Poprad、斯洛伐克、05801
        • DENTAVIA s.r.o.
      • Spišská Nová Ves、斯洛伐克、052 01
        • Diabetologicka ambulancia MUDr. Gabriela Zimova
      • Svidník、斯洛伐克、08901
        • SIRCO 2, s. r. o.
      • Al Ahsa、沙特阿拉伯、36428
        • National Guard- Alahsa
      • Jeddah、沙特阿拉伯、21423
        • King Abdullah International Medical Research Center KAIMRC
      • Jeddah、沙特阿拉伯、21589
        • King Fahd Medical Research Center-King Abdulaziz University
      • Khobar、沙特阿拉伯、34445
        • King Fahad Hospital of the University
      • Riyadh、沙特阿拉伯、59046
        • King Fahad Medical City
      • Riyadh、沙特阿拉伯、12372
        • King Khaled University Hospital,King Saud Univ. Med. City
      • Riyadh、沙特阿拉伯、11481
        • King Abdullah International Medical Research Center KAIMRC
      • Riyadh、沙特阿拉伯、11499
        • King Faisal Specialist Hospital & Research Centre, Riyadh
      • Ulaishah, Riyadh、沙特阿拉伯、12746
        • King Saud Medical City Hospital
      • Chojnice、波兰、89-600
        • OptiTrial Sp. z o.o.
      • Lublin、波兰、20-607
        • Reumed Sp. z o.o.
      • Piotrkow Trybunalski、波兰、97-300
        • Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
      • Tarnów、波兰、33-100
        • Metabolica Sp. z o.o.
      • Warsaw、波兰、00-710
        • NBR Polska Tomasz Klodawski
      • Zabrze、波兰、41-800
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
    • Dolnosląskie
      • Wroclaw、Dolnosląskie、波兰、51-124
        • Clinical Study Center S.C.
    • Podlaskie Voivodeship
      • Bialystok、Podlaskie Voivodeship、波兰、15-435
        • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
      • San Juan、波多黎各、00907
        • Solace Clinical Research
    • New South Wales
      • Castle Hill、New South Wales、澳大利亚、2154
        • Castle Hill Medical Centre
      • Macquarie Park、New South Wales、澳大利亚、2109
        • Macquarie University - Clinical Trials Unit
    • Queensland
      • Douglass、Queensland、澳大利亚、4814
        • Townsville University Hospital - Diabetes and Endocrine Department
      • Meadowbrook、Queensland、澳大利亚、4131
        • Logan Hospital
      • Toowoomba、Queensland、澳大利亚、4350
        • Regional Research Institute
    • Victoria
      • Clayton、Victoria、澳大利亚、3168
        • Monash Medical Centre - Bone and Muscle Research Group
      • Parkville、Victoria、澳大利亚、3050
        • The Royal Melbourne Hospital - Diabetes & Endocrinology Department
      • Torquay、Victoria、澳大利亚、3228
        • Clinical Trials Institute
      • Brasov、罗马尼亚、500260
        • Diabet Center SRL
      • Paşcani、罗马尼亚、705200
        • Bella Praxis S.R.L.
      • Piteşti、罗马尼亚、110017
        • Medis Muntenia SRL
    • Bihor County
      • Oradea、Bihor County、罗马尼亚、410159
        • Grandmed SRL
    • Bucharest
      • Bucharest、Bucharest、罗马尼亚、020475
        • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
    • Maramureş
      • Baia Mare、Maramureş、罗马尼亚、430222
        • CMI Dr Pop Lavinia
    • Prahova
      • Ploieşti、Prahova、罗马尼亚、100179
        • Diabmed Dr Popescu Alexandrina SRL
      • Ploieşti、Prahova、罗马尼亚、100342
        • CMI Dr. Busegeanu Mihaela Magdalena
    • Arizona
      • Phoenix、Arizona、美国、85016
        • Rio Clinical Trials Arizona
    • California
      • La Jolla、California、美国、92037
        • Scripps Whittier Diabetes Inst
      • La Mesa、California、美国、91942
        • Diabetes & Endocrine Specialists - La Mesa
      • Lancaster、California、美国、93534
        • First Valley Med Grp Lancaster
      • Los Angeles、California、美国、90015
        • Los Angeles Institute for Metabolic Research
      • Northridge、California、美国、91325
        • Valley Clinical Trials, Inc.
      • Palm Springs、California、美国、92262
        • Desert Oasis Hlthcr Med Group
      • San Diego、California、美国、92111
        • Linda Vista Health Care Ctr
      • Santa Ana、California、美国、92701
        • Southern Cal Clinical Research
      • Spring Valley、California、美国、91978
        • Encompass Clinical Research_Spring Valley
      • Walnut Creek、California、美国、94598
        • Diablo Clinical Research, Inc.
    • Connecticut
      • Waterbury、Connecticut、美国、06708
        • Chase Medical Research LLC
    • Florida
      • Hollywood、Florida、美国、33024
        • Encore Medical Research LLC
      • Jacksonville、Florida、美国、32256
        • University of Florida Cardiology
      • Miami、Florida、美国、33165
        • New Horizon Research Center
      • Miami、Florida、美国、33155
        • My Preferred Research
      • Miami、Florida、美国、33173
        • GTL Med & Res Group
      • Miami Gardens、Florida、美国、33014
        • Life Medical Research Group
      • Miramar、Florida、美国、33027
        • South Broward Research LLC
      • Mt. Dora、Florida、美国、32757
        • Adult Medicine of Lake County, Inc
      • Ocoee、Florida、美国、34761
        • West Orange Endocrinology
      • Orlando、Florida、美国、32825
        • Florida Institute for Clinical research
      • Tampa、Florida、美国、36607
        • True Blue Clinical Research
      • Weston、Florida、美国、33331
        • Encore Medical Research of Weston
    • Idaho
      • Meridian、Idaho、美国、83646
        • Solaris Clinical Research
    • Illinois
      • Gurnee、Illinois、美国、60031
        • Clinical Invest Special_Gurnee
    • Kansas
      • Topeka、Kansas、美国、66606
        • Cotton O'Neil Diab & Endo Ctr
    • Maryland
      • Olney、Maryland、美国、20832
        • MedStar Health Research Institute
      • Rockville、Maryland、美国、20852
        • Endo And Metab Cons
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Brigham & Women's Hospital
    • Michigan
      • Flint、Michigan、美国、48532
        • Elite Clinical Research
    • Missouri
      • City of Saint Peters、Missouri、美国、63303
        • StudyMetrix Research LLC
    • Nevada
      • Las Vegas、Nevada、美国、89148
        • Palm Research Center Inc-Vegas
    • New Hampshire
      • Nashua、New Hampshire、美国、03060
        • Southern NH Diabetes and Endo_Nashua
    • New York
      • Albany、New York、美国、12203
        • AMC Community Endocrinology
      • West Seneca、New York、美国、14224
        • Southgate Medical Group, LLP
    • North Carolina
      • Greensboro、North Carolina、美国、27408
        • PharmQuest Life Sciences LLC
      • Monroe、North Carolina、美国、28112
        • Monroe Biomedical Research, LLC
      • Wilmington、North Carolina、美国、28401
        • Accellacare
    • Ohio
      • Canton、Ohio、美国、44718
        • Diab & Endo Assoc of Stark Co
    • South Carolina
      • Charleston、South Carolina、美国、29407
        • DelRicht Research at Newton Family Medicine
      • Spartanburg、South Carolina、美国、29303
        • Spartanburg Medical Research
    • South Dakota
      • Sioux Falls、South Dakota、美国、57104
        • South Dakota Urban Indian Health
    • Tennessee
      • Bristol、Tennessee、美国、37620-7352
        • Holston Medical Group Pc
      • Kingsport、Tennessee、美国、37660
        • Holston Medical Group
      • Nashville、Tennessee、美国、37203
        • Clinical Research Associates
    • Texas
      • Houston、Texas、美国、77074
        • Southwest Clinical Trials
      • Houston、Texas、美国、77024
        • Victorium Clinical Research
      • Katy、Texas、美国、77450
        • Medical Colleagues-Texas LLP
      • San Antonio、Texas、美国、78233
        • NE Clin Res of San Antonio
      • San Antonio、Texas、美国、78222
        • Pinnacle Clinical Research
      • Shavano Park、Texas、美国、78231
        • Consano Clinical Research, LLC
      • Weslaco、Texas、美国、78596
        • Texas Valley Clinical Research
    • Utah
      • Sandy City、Utah、美国、84093
        • Diabetes & Endo Treatment Spec
    • Washington
      • Renton、Washington、美国、98057
        • Rainier Clin Res Ctr Inc
      • Blackburn、英国、BB2 1AX
        • Oakenhurst Medical Practice
      • Chippenham、英国、SN14 6GT
        • Hathaway Medical Centre
      • London、英国、SW1P 2PF
        • Healthcare Central London - South Westminster Centre for Health
      • Nantwich、英国、CW5 5NX
        • Kiltearn Medical Centre
      • Rotherham、英国、S61 1AH
        • Woodstock Bower Group Practice
      • Sandbach、英国、CW11 1EQ
        • Ashfields Primary Care Centre
      • Swansea、英国、SA2 8PP
        • Joint Clinical Research Facility - Swansea
    • Cornwall
      • Liskeard、Cornwall、英国、PL14 3XA
        • Oak Tree Surgery
      • Truro、Cornwall、英国、TR1 3LJ
        • Royal Cornwall Hospital (Treliske) - Diabetes
    • Devon
      • Torquay、Devon、英国、TQ1 4QX
        • Brunel Medical Practice
    • Hertfordshire
      • Bushey、Hertfordshire、英国、WD23 2NN
        • Attenborough Surgery
      • Almada、葡萄牙、2805-267
        • ULS Almada-Seixal E.P.E. - HGO_Serviço de Endocrinologia
      • Braga、葡萄牙、4710-243
        • ULS De Braga, E.P.E. - Hospital de Braga_Centro Clínico Académico
      • Coimbra、葡萄牙、3000-150
        • Casa De Saúde De Santa Filomena S.A._Unidade de Ensaios Clínicos
      • Guarda、葡萄牙、6301-858
        • ULS Da Guarda E.P.E. - Hospital Sousa Martins_Serviço de Medicina Interna
      • Guimarães、葡萄牙、4835-044
        • ULS Do Alto Ave, E.P.E - HSOG_Centro de Investigação Clínica
      • Leiria、葡萄牙、2400-110
        • Hospital São Francisco, S.A_EECC
      • Lisbon、葡萄牙、1449-005
        • ULS Lisboa Ocidental, E.P.E_Hospital São Francisco Xavier_Hospital de Dia de Especialidades Médicas
      • Lisbon、葡萄牙、1350-345
        • Hospital CUF Tejo, S.A._Serviço Endocrinologia
      • Ponte de Lima、葡萄牙、4990-029
        • Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda
      • Porto、葡萄牙、4100-180
        • CUF Porto_Serviço de Medicina Interna
      • Senhora Da Hora, Matosinhos、葡萄牙、4464-513
        • ULS De Matosinhos, E.P.E - HPH_Serviço de Endocrinologia
      • Setúbal、葡萄牙、2900-722
        • Hospital da Luz Setúbal, S.A._Serviço de Medicina Interna
      • Viseu、葡萄牙、3500-093
        • Casa de Saúde de São Mateus, S.A.
      • Almería、西班牙、04009
        • Centro Periferico De Especialidades Bola Azul
      • Barcelona、西班牙、08017
        • CAP Sarrià
      • Barcelona、西班牙、08023
        • EBA Vallcarca SLP
      • Barcelona、西班牙、08028
        • CAPSBE_CAP Ernest LLuch
      • Barcelona、西班牙、08360
        • CAP Canet de Mar
      • Cabra、西班牙、14940
        • Centro de Salud Cabra Matrona Antonia Mesa
      • Castilleja de la Cuesta、西班牙、41950
        • Hospital Vithas Sevilla
      • La Cuesta (Santa Cruz de Tenerife)、西班牙、38320
        • Centro de Salud La Cuesta
      • Pozuelo de Alarcón、西班牙、28223
        • Centro de Salud San Juan de la Cruz
      • Santander、西班牙、39008
        • H. Univ. Marqués de Valdecilla_Endocrinología
    • Barcelona
      • Sant Cugat del Vallès、Barcelona、西班牙、08173
        • CAP Turó de Can Mates
      • Vic、Barcelona、西班牙、08500
        • Equip D'assistencia Primaria Vic S.L.P.
      • Buenos Aires、阿根廷、C1015
        • OMI- Organización Médica de Investigación
      • San Nicolás、阿根廷、B2900
        • Instituto de Investigaciones Clinicas San Nicolás
      • Santa Fe、阿根廷、S3000FSO
        • CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
      • Santa Fe、阿根廷、S2152BOF
        • Centro de Investigaciones Clinica Baigorria
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires、Buenos Aires、阿根廷、C1424CIQ
        • CICEMO- Consultorio (Av Directorio)
      • Mar del Plata、Buenos Aires、阿根廷、B7600FZN
        • Instituto de Investigaciones Clinicas Mar Del Plata
    • Santa Fe Province
      • Rafaela、Santa Fe Province、阿根廷、S2300
        • Mains Bleues SA

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Zenagamtide

Participants will receive zenagamtide subcutaneously once weekly

Zenagamtide will be administered subcutaneously

有源比较器:Semaglutide

Participants will receive semaglutide subcutaneously once weekly

Semaglutide will be administered subcutaneously

安慰剂比较:Placebo

Participants will receive placebo matched to semaglutide or zenagamtide subcutaneously once weekly

Placebo matched to semaglutide or zenagamtide will be administered subcutaneously

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in glycated haemoglobin (HbA1c) [non-inferiority]
大体时间:From baseline (week 0) to week 60

Measured in percentage point

From baseline (week 0) to week 60

次要结果测量

结果测量
措施说明
大体时间
Relative change in body weight
大体时间:From baseline (week 0) to week 60

Measured in percentage

From baseline (week 0) to week 60
Change in glycated haemoglobin (HbA1c) [superiority]
大体时间:From baseline (week 0) to week 60

Measured in percentage point

From baseline (week 0) to week 60
Change in triglycerides
大体时间:From baseline (week 0) to week 60

Measured in ratio to baseline

From baseline (week 0) to week 60
Change in systolic blood pressure
大体时间: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
大体时间: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)
大体时间:From baseline (week 0) to week 60

Measured in ratio to baseline

From baseline (week 0) to week 60

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Clinical Transparency (dept. 2834)、Novo Nordisk A/S

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月10日

初级完成 (估计的)

2028年7月4日

研究完成 (估计的)

2028年8月8日

研究注册日期

首次提交

2026年11月6日

首先提交符合 QC 标准的

2026年11月6日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • NN9489-8035
  • U1111-1335-3379 (其他标识符:World Health Organization (WHO))
  • 2026-525472-26 (其他标识符:European Medical Agency (EMA))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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