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)

November 6, 2026 updated by: 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • 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
  • Australia
    • 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
  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil, 80810-040
        • Centro de Diabetes Curitiba
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
        • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
    • São Paulo
      • Campinas, São Paulo, Brazil, 13060-803
        • PUCCAMP - Hospital e Maternidade Celso Pierro
      • São Paulo, São Paulo, Brazil, 05403-000
        • Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP
      • São Paulo, São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica Ltda
      • São Paulo, São Paulo, Brazil, 01228-200
        • CPCLIN - Centro de Pesquisas Clínicas
  • Bulgaria
      • 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
  • Canada
      • 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
  • Croatia
      • Karlovac, Croatia, 47000
        • Opca bolnica Karlovac_Endocrinology
      • Krapinske Toplice, Croatia, 49217
        • Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
      • Osijek, Croatia, 31 000
        • Klinicki bolnicki centar Osijek_Endocrinology
      • Rijeka, Croatia, 51 000
        • Clinical Hospital Centre Rijeka_Endocrinology
      • Slavonski Brod, Croatia, 35 000
        • General Hospital Dr. Josip Bencevic_Diabetic department
      • Solin, Croatia, 21210
        • Poliklinika za oftalmologiju optometriju i neurologiju Lux
      • Zagreb, Croatia, 10000
        • Poliklinika Solmed
  • Czechia
      • Chrudim III, Czechia, 53701
        • INTENDIA klinika s.r.o.
      • Hranice, Czechia, 753 01
        • AIDIN VK s.r.o.
      • Olomouc, Czechia, 779 00
        • Diabetologické centrum s.r.o.
      • Prague, Czechia, 110 00
        • Diabet2 s.r.o.
      • Prague, Czechia, 150 00
        • EUC Klinika Praha a.s.
      • Prague, Czechia, 10400
        • ENDOTRIAL s.r.o.
      • Prague, Czechia, 149 00
        • Milan Kvapil s.r.o.
      • Prague, Czechia, 160 00
        • Fledip s.r.o.
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus Universitetshospital, Steno Diabetes Center Aarhus
      • Gandrup, Denmark, 9362
        • Sanos Clinic - Gandrup
      • Herlev, Denmark, 2730
        • Steno Diabetes Center Copenhagen
      • Odense C, Denmark, 5000
        • Steno Diabetes Center Odense
    • Region Sjælland
      • Køge, Region Sjælland, Denmark, 4600
        • Sjællands Universitetshospital, Køge - Medicinsk Afdeling
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Herz- und Diabeteszentrum NRW - Bad Oeynhausen
      • Berlin, Germany, 13597
        • Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
      • Duisburg, Germany, 47269
        • MVZ Hausärzte Großenbaum GmbH Duisburg
      • Falkensee, Germany, 14612
        • Zentrum für klinische Forschung, Dr. med. Lüdemann
      • Gladbeck, Germany, 45968
        • Hausarztzentrum Butendorf
      • Hamburg, Germany, 22607
        • Wendisch - Dahl Hamburg - DZHW
      • Köln-Dünnwald, Germany, 51069
        • Zentrum für Klinische Forschung Köln-Dünnwald
      • Leipzig, Germany, 04249
        • Gemeinschaftspraxis Dr. Täschner/Dr. Bonigut
      • Münster, Germany, 48153
        • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
      • Pirna, Germany, 01796
        • Hausärztliche und Diabetologische Praxis Pirna
      • Pohlheim, Germany, 35415
        • ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
      • Reinfeld, Germany, 23858
        • Praxis Reinfeld Mitte
      • Villingen-Schwenningen, Germany, 78048
        • Praxis für Prävention und Therapie, Drs Jacob
  • Greece
      • Athens, Greece, 11527
        • General Hospital Of Athens G Gennimatas - Department of Endocrinology
      • Chios, Greece, 82131
        • General Hospital of Chios "Skilitsio" - Internal Medicine Department
      • Goudi/Athens, Greece, 11527
        • "Laiko" General Hospital of Athens
      • Ioannina, Greece, 455 00
        • University General Hospital of Ioannina, Endocrinology Department and Diabetes Centre
      • Kalamata, Greece, 24131
        • City Hospital Kliniki Monoprosopi I.K.E. - Endocrinology Department
      • Larissa, Greece, 41110
        • University General Hospital of Larissa - Department of Endocrinology and Metabolic Diseases
      • Palaió Fáliro, Greece, 17562
        • Athens Medical Center S.A. (Iatriko P. Falirou) - Diabetes and Clinical Research Center
      • Thessaloniki, Greece, 546 35
        • General Hospital Of Thessaloniki G Gennimatas - Internal Medicine Clinic
      • Thessaloniki, Greece, 57001
        • Thermi Clinic S.A. - Diabetes and Internal Medicine Department
      • Thessaloniki, Greece, 54635
        • NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes
      • Thessaloniki, Greece, 570 10
        • Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department
  • Hungary
      • Balatonfüred, Hungary, 8230
        • DRC Kft.
      • Békéscsaba, Hungary, 5600
        • Trial Pharma Kft.
      • Kaposvár, Hungary, 7400
        • Somogy Vármegyei Kaposi Mór Oktató Kórház
    • Bekes County
      • Gyula, Bekes County, Hungary, 5700
        • Békés Vármegyei Központi Kórház
    • Bács-Kiskun county
      • Baja, Bács-Kiskun county, Hungary, 6500
        • Lausmed Kft.
      • Kecskemét, Bács-Kiskun county, Hungary, 6000
        • KomplexLabor Diagnosztika Kft.
    • Csongrád-Csanád
      • Szeged, Csongrád-Csanád, Hungary, 6725
        • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Medifarma-98 Kft.
  • Israel
      • 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
  • Italy
      • Roma, Italy, 00161
        • Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale
      • Rozzano (MI), Italy, 20089
        • IRCCS Humanitas - U.O. Endocrinologia e Diabetologia
    • Apulia
      • Acquaviva delle Fonti, Apulia, Italy, 70021
        • Ente Ecclesiastico Ospedale Generale Regionale Miulli - Endocrinologia
      • Bari, Apulia, Italy, 70124
        • AOU Consorziale Policlinico Bari - U.O.C. Endocrinologia Universitaria
    • Emilia-Romagna
      • Parma, Emilia-Romagna, Italy, 43126
        • Azienda Ospedaliera - Universitaria Parma - UOC di Endocrinologia e Malattie del Metabolismo
      • Ravenna, Emilia-Romagna, Italy, 48121
        • AUSL Romagna - Distretto di Ravenna - Ospedale Santa Maria delle Croci
    • Lombardy
      • Milan, Lombardy, Italy, 20157
        • ASST Fatebenefratelli Ospedale Luigi Sacco - Malattie Endocrine e Diabetologia
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Azienda Ospedaliero Universitaria Careggi - Diabetologia e malattie del metabolismo
    • Umbria
      • Perugia, Umbria, Italy, 06129
        • A.O.S. Maria della Misericordia - Dipartimento di Medicina Generale e Specialistica
  • Poland
      • Chojnice, Poland, 89-600
        • OptiTrial Sp. z o.o.
      • Lublin, Poland, 20-607
        • Reumed Sp. z o.o.
      • Piotrkow Trybunalski, Poland, 97-300
        • Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
      • Tarnów, Poland, 33-100
        • Metabolica Sp. z o.o.
      • Warsaw, Poland, 00-710
        • NBR Polska Tomasz Klodawski
      • Zabrze, Poland, 41-800
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
    • Dolnosląskie
      • Wroclaw, Dolnosląskie, Poland, 51-124
        • Clinical Study Center S.C.
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-435
        • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
  • Portugal
      • 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.
  • Puerto Rico
      • San Juan, Puerto Rico, 00907
        • Solace Clinical Research
  • Romania
      • 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
  • Saudi Arabia
      • 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
  • Slovakia
      • 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.
  • Spain
      • Almería, Spain, 04009
        • Centro Periferico De Especialidades Bola Azul
      • Barcelona, Spain, 08017
        • CAP Sarrià
      • Barcelona, Spain, 08023
        • EBA Vallcarca SLP
      • Barcelona, Spain, 08028
        • CAPSBE_CAP Ernest LLuch
      • Barcelona, Spain, 08360
        • CAP Canet de Mar
      • Cabra, Spain, 14940
        • Centro de Salud Cabra Matrona Antonia Mesa
      • Castilleja de la Cuesta, Spain, 41950
        • Hospital Vithas Sevilla
      • La Cuesta (Santa Cruz de Tenerife), Spain, 38320
        • Centro de Salud La Cuesta
      • Pozuelo de Alarcón, Spain, 28223
        • Centro de Salud San Juan de la Cruz
      • Santander, Spain, 39008
        • H. Univ. Marqués de Valdecilla_Endocrinología
    • Barcelona
      • Sant Cugat del Vallès, Barcelona, Spain, 08173
        • CAP Turó de Can Mates
      • Vic, Barcelona, Spain, 08500
        • Equip D'assistencia Primaria Vic S.L.P.
  • United Kingdom
      • Blackburn, United Kingdom, BB2 1AX
        • Oakenhurst Medical Practice
      • Chippenham, United Kingdom, SN14 6GT
        • Hathaway Medical Centre
      • London, United Kingdom, SW1P 2PF
        • Healthcare Central London - South Westminster Centre for Health
      • Nantwich, United Kingdom, CW5 5NX
        • Kiltearn Medical Centre
      • Rotherham, United Kingdom, S61 1AH
        • Woodstock Bower Group Practice
      • Sandbach, United Kingdom, CW11 1EQ
        • Ashfields Primary Care Centre
      • Swansea, United Kingdom, SA2 8PP
        • Joint Clinical Research Facility - Swansea
    • Cornwall
      • Liskeard, Cornwall, United Kingdom, PL14 3XA
        • Oak Tree Surgery
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital (Treliske) - Diabetes
    • Devon
      • Torquay, Devon, United Kingdom, TQ1 4QX
        • Brunel Medical Practice
    • Hertfordshire
      • Bushey, Hertfordshire, United Kingdom, WD23 2NN
        • Attenborough Surgery
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Rio Clinical Trials Arizona
    • California
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Inst
      • La Mesa, California, United States, 91942
        • Diabetes & Endocrine Specialists - La Mesa
      • Lancaster, California, United States, 93534
        • First Valley Med Grp Lancaster
      • Los Angeles, California, United States, 90015
        • Los Angeles Institute for Metabolic Research
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • Palm Springs, California, United States, 92262
        • Desert Oasis Hlthcr Med Group
      • San Diego, California, United States, 92111
        • Linda Vista Health Care Ctr
      • Santa Ana, California, United States, 92701
        • Southern Cal Clinical Research
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research_Spring Valley
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research LLC
    • Florida
      • Hollywood, Florida, United States, 33024
        • Encore Medical Research LLC
      • Jacksonville, Florida, United States, 32256
        • University of Florida Cardiology
      • Miami, Florida, United States, 33165
        • New Horizon Research Center
      • Miami, Florida, United States, 33155
        • My Preferred Research
      • Miami, Florida, United States, 33173
        • GTL Med & Res Group
      • Miami Gardens, Florida, United States, 33014
        • Life Medical Research Group
      • Miramar, Florida, United States, 33027
        • South Broward Research LLC
      • Mt. Dora, Florida, United States, 32757
        • Adult Medicine of Lake County, Inc
      • Ocoee, Florida, United States, 34761
        • West Orange Endocrinology
      • Orlando, Florida, United States, 32825
        • Florida Institute for Clinical research
      • Tampa, Florida, United States, 36607
        • True Blue Clinical Research
      • Weston, Florida, United States, 33331
        • Encore Medical Research of Weston
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Clinical Invest Special_Gurnee
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Diab & Endo Ctr
    • Maryland
      • Olney, Maryland, United States, 20832
        • MedStar Health Research Institute
      • Rockville, Maryland, United States, 20852
        • Endo And Metab Cons
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • Michigan
      • Flint, Michigan, United States, 48532
        • Elite Clinical Research
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center Inc-Vegas
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Southern NH Diabetes and Endo_Nashua
    • New York
      • Albany, New York, United States, 12203
        • AMC Community Endocrinology
      • West Seneca, New York, United States, 14224
        • Southgate Medical Group, LLP
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest Life Sciences LLC
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research, LLC
      • Wilmington, North Carolina, United States, 28401
        • Accellacare
    • Ohio
      • Canton, Ohio, United States, 44718
        • Diab & Endo Assoc of Stark Co
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • DelRicht Research at Newton Family Medicine
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • South Dakota Urban Indian Health
    • Tennessee
      • Bristol, Tennessee, United States, 37620-7352
        • Holston Medical Group Pc
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates
    • Texas
      • Houston, Texas, United States, 77074
        • Southwest Clinical Trials
      • Houston, Texas, United States, 77024
        • Victorium Clinical Research
      • Katy, Texas, United States, 77450
        • Medical Colleagues-Texas LLP
      • San Antonio, Texas, United States, 78233
        • NE Clin Res of San Antonio
      • San Antonio, Texas, United States, 78222
        • Pinnacle Clinical Research
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
      • Weslaco, Texas, United States, 78596
        • Texas Valley Clinical Research
    • Utah
      • Sandy City, Utah, United States, 84093
        • Diabetes & Endo Treatment Spec
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clin Res Ctr Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Zenagamtide

Participants will receive zenagamtide subcutaneously once weekly
Drug: Zenagamtide

Zenagamtide will be administered subcutaneously
Active Comparator: Semaglutide

Participants will receive semaglutide subcutaneously once weekly
Drug: Semaglutide

Semaglutide will be administered subcutaneously
Placebo Comparator: Placebo

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

Placebo matched to semaglutide or zenagamtide will be administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in glycated haemoglobin (HbA1c) [non-inferiority]
Time Frame: From baseline (week 0) to week 60

Measured in percentage point
From baseline (week 0) to week 60

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relative change in body weight
Time Frame: From baseline (week 0) to week 60

Measured in percentage
From baseline (week 0) to week 60
Change in glycated haemoglobin (HbA1c) [superiority]
Time Frame: From baseline (week 0) to week 60

Measured in percentage point
From baseline (week 0) to week 60
Change in triglycerides
Time Frame: From baseline (week 0) to week 60

Measured in ratio to baseline
From baseline (week 0) to week 60
Change in systolic blood pressure
Time Frame: 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
Time Frame: 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)
Time Frame: From baseline (week 0) to week 60

Measured in ratio to baseline
From baseline (week 0) to week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 4, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9489-8035
  • U1111-1335-3379 (Other Identifier: World Health Organization (WHO))
  • 2026-525472-26 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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