A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both

Last updated: April 20, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Diabetes Prevention

Treatment

Tirzepatide

Semaglutide

Cagrilintide

Clinical Study ID

NCT06534411
NN9388-7741
2023-509600-15
U1111-1300-2590
  • Ages > 18
  • All Genders

Study Summary

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female (sex at birth).

  • Age 18 years or above at the time of signing the informed consent.

  • Diagnosed with type 2 diabetes mellitus greater than or equal to (>=) 180 daysbefore screening.

  • Stable daily dose(s) >= 90 days before screening of any of the followingantidiabetic drug(s) or combination regimen(s) at effective or maximum tolerateddose as judged by the investigator:

  • Metformin

  • sodium-glucose co-transporter 2 inhibitor (SGLT2i)

  • Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol [mmol/mol]) (both inclusive) as determined by central laboratory at screening.

  • Body mass index (BMI) >= 30 kilogram per square meter (kg/m^2) at screening. BMIwill be calculated in the electronic case report form (eCRF) based on height andbody weight at screening.

Exclusion

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is ofchildbearing potential and not using a highly effective contraceptive method.

  • Renal impairment with estimated Glomerular Filtration Rate less than < 30 milliliterper minute per 1.73 square meter (mL/min/1.73 m^2) as determined by centrallaboratory at screening.

  • Treatment with any anti-diabetic or anti-obesity medication (irrespective ofindication) other than stated in the inclusion criteria within 90 days beforescreening. However, short term insulin treatment for a maximum of 14 consecutivedays is allowed.

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby an eye examination performed within 90 days before screening or in the periodbetween screening and randomisation. Pharmacological pupil-dilation is a requirementunless using a digital fundus photography camera specified for non-dilatedexamination.

Study Design

Total Participants: 1023
Treatment Group(s): 3
Primary Treatment: Tirzepatide
Phase: 3
Study Start date:
November 05, 2024
Estimated Completion Date:
August 18, 2026

Connect with a study center

  • Centro Médico CIMEL

    Lanus Este, Buenos Aires B1824KAJ
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Clínica de Fracturas y Or

    Mar del Plata, Buenos Aires B7600GNY
    Argentina

    Site Not Available

  • Fundación CESIM

    Santa Rosa, La Pampa 6300
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Tucumán

    San Miguel De Tucuimán, Tucumán 4000
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas

    City of Buenos Aires, C1056ABI
    Argentina

    Site Not Available

  • IMOBA

    City of Buenos Aires, C1056ABH
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas San Nicolás

    San Nicolás, B2900
    Argentina

    Site Not Available

  • Paratus Clinical

    Bruce, Australian Capital Territory 2617
    Australia

    Site Not Available

  • Hunter Diabetes Centre

    Merewether, New South Wales 2291
    Australia

    Site Not Available

  • Austrials

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Momentum Clinical Research

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Roger Chih Yu Chen

    Sydney, New South Wales 2148
    Australia

    Site Not Available

  • Western Endocrine Blacktown

    Sydney, New South Wales 2148
    Australia

    Site Not Available

  • Townsville University Hospital

    Douglas, Queensland 4814
    Australia

    Site Not Available

  • Paratus Clinical

    Herston, Queensland 4006
    Australia

    Site Not Available

  • Centro de Diabetes Curitiba

    Curitiba, Parana 80810-040
    Brazil

    Site Not Available

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

    Porto Alegre, Rio Grande Do Sul 90430-001
    Brazil

    Site Not Available

  • CPQuali Pesquisa Clínica Ltda

    São Paulo, Sao Paulo 01228-000
    Brazil

    Site Not Available

  • Hilltop Medical Clinic

    Surrey, British Columbia V4A 0C1
    Canada

    Site Not Available

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick E1G 1A7
    Canada

    Site Not Available

  • Centricity Research Brampton

    Brampton, Ontario L6S 0C6
    Canada

    Site Not Available

  • Centricity Research Etobicoke

    Etobicoke, Ontario M9R 4E1
    Canada

    Site Not Available

  • Wharton Med Clin Trials

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • London Road Diagnostic Clinic and Medical Centre

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Diabetes Heart Research Centre

    Toronto, Ontario M6G 1M2
    Canada

    Site Not Available

  • Ctr de rech Clin de Laval

    Laval, Quebec H7T 2P5
    Canada

    Site Not Available

  • Alpha Recherche Clinique - Clinique de Levis

    Levis, Quebec G6V 0C9
    Canada

    Site Not Available

  • Centre Medical Acadie

    Montreal, Quebec H4N 2W2
    Canada

    Site Not Available

  • Ctr de Med Metab de Lanaudiere

    Terrebonne, Quebec J6X 4P7
    Canada

    Site Not Available

  • Diex Recherche Victoriaville

    Victoriaville, Quebec G6P 3Z8
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, 32545
    Germany

    Site Not Available

  • Klinik für Endokrinologie, Diabetologie und Stoffwechsel

    Essen, 45147
    Germany

    Site Not Available

  • Klinik für Endokrinologie, Diabetologie und Stoffwechsel - Uniklinik Essen

    Essen, 45147
    Germany

    Site Not Available

  • Praxis am Markt Dr. Becker

    Essen, 45355
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg - Innere Medizin II

    Freiburg, 79106
    Germany

    Site Not Available

  • Wendisch/Dahl Hamburg

    Hamburg, 22607
    Germany

    Site Not Available

  • Medicover Neuroendokrinologie MVZ

    München, 81667
    Germany

    Site Not Available

  • MedicalCenter am Clemenshospital

    Münster, 48153
    Germany

    Site Not Available

  • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

    Münster, 48153
    Germany

    Site Not Available

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen, 88239
    Germany

    Site Not Available

  • Alexandra General Hospital, Therapeutic Clinic

    Athens, Attiki 11528
    Greece

    Site Not Available

  • Venizeleio Pananeio

    Heraklion, Crete 71409
    Greece

    Site Not Available

  • Evangelismos Hospital

    Athens, 10676
    Greece

    Site Not Available

  • Iatriko Athinon 'Palaiou Falirou'

    Athens, 17562
    Greece

    Site Not Available

  • "Laiko" General Hospital of Athens

    Goudi/Athens, 11527
    Greece

    Site Not Available

  • University General Hospital of Ioannina,Internal Medicine

    Ioannina, 45500
    Greece

    Site Not Available

  • 'Ippokrateio' General Hospital of Thessaloniki

    Thessaloniki, 54642
    Greece

    Site Not Available

  • General Hospital of Thessaloniki 'G. Gennimatas

    Thessaloniki, 54635
    Greece

    Site Not Available

  • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

    Szeged, Csongrád-Csanád 6725
    Hungary

    Site Not Available

  • Selye János Kórház és Rendelőintézet

    Komárom, Komárom-Esztergom 2900
    Hungary

    Site Not Available

  • QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft

    Budapest, Pest 1036
    Hungary

    Site Not Available

  • ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.

    Budapest, 1089
    Hungary

    Site Not Available

  • MED-TIMA Kft.

    Budapest, 1132
    Hungary

    Site Not Available

  • PVN Kutato Kft.

    Budapest, 1102
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1083
    Hungary

    Site Not Available

  • Szőcs Depot Egészségügyi Szolgáltató Kft.

    Budapest, 1042
    Hungary

    Site Not Available

  • Észak-Pesti Centrumkórház Honvédkórház

    Budapest, 1134
    Hungary

    Site Not Available

  • Óbudai Egészségügyi Centrum

    Budapest, 1036
    Hungary

    Site Not Available

  • Endolife Specialty Hospitals

    Guntur, Andhra Pradesh 522001
    India

    Site Not Available

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi, Delhi 110029
    India

    Site Not Available

  • Ramaiah Memorial Hospital

    Bengaluru, Karnataka 560054
    India

    Site Not Available

  • Excel Endocrine Centre

    Kolhapur, Maharashtra 416008
    India

    Site Not Available

  • Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha

    Wardha, Maharashtra 442001
    India

    Site Not Available

  • Jawahar Lal Nehru Govt. Medical College

    Ajmer, Rajasthan 305001
    India

    Site Not Available

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan 302006
    India

    Site Not Available

  • SMS Hospital

    Jaipur, Rajasthan 302004
    India

    Site Not Available

  • Arthur Asirvatham hospital,

    Madurai, Tamil Nadu 625 020
    India

    Site Not Available

  • AIG Hospitals,Hyderabad

    Hyderabad, Telangana 500032
    India

    Site Not Available

  • Udyaan Health Care

    Lucknow, Uttar Pradesh 226002
    India

    Site Not Available

  • IPGME&R and SSKM Hospital

    Kolkata, West Bengal 700020
    India

    Site Not Available

  • Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

    Puducherry, 605006
    India

    Site Not Available

  • Diabetes and obesity center of excellence, Rambam MC

    Haifa, 31096
    Israel

    Site Not Available

  • Clalit sick fund Herzlia

    Herzlia, 4630945
    Israel

    Site Not Available

  • Diabetes Clinic Wolfson MC

    Holon, 58100
    Israel

    Site Not Available

  • Diabetes Unit Hadassah Ein Karem MC

    Jerusalem, 91120
    Israel

    Site Not Available

  • Rabin MC Beilinson Campus Endo

    Petah-Tikva, 49100
    Israel

    Site Not Available

  • Endrocrinolgy Clinic - Sheba Medical Center

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • Institute of Endocrinology, metabolism and hypertension

    Tel-Aviv, 6423906
    Israel

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship 15-276
    Poland

    Site Not Available

  • Diab Serwis Popenda Spółka Jawna

    Chorzów, 41-516
    Poland

    Site Not Available

  • Specjalistyczny Gabinet Diabetologiczny Rumianowski Radosław

    Gorzow Wielkopolski, 66-400
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

    Lodz, 90-338
    Poland

    Site Not Available

  • Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A.

    Olsztyn, 10-117
    Poland

    Site Not Available

  • Kiepury Clinic MAŁGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POŁOŻNICZA

    Sosnowiec, 41-209
    Poland

    Site Not Available

  • Centrum Medyczne Oporow

    Wroclaw, 52-416
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko

    Zabrze, 41-800
    Poland

    Site Not Available

  • Diabdana S.R.L.

    Oradea, Bihor 410147
    Romania

    Site Not Available

  • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila

    Bucharest, Bucurestii 020475
    Romania

    Site Not Available

  • CMI Dr Pop Lavinia

    Baia Mare, Maramures 430222
    Romania

    Site Not Available

  • Sc Mediab Srl

    Tirgu Mures, Mures 540142
    Romania

    Site Not Available

  • SC Nutrilife SRL

    Bucharest, 013764
    Romania

    Site Not Available

  • Diabet Med SRL

    Bucuresti, 050913
    Romania

    Site Not Available

  • Sanamed Hospital SRL

    Bucuresti, 060013
    Romania

    Site Not Available

  • Clinica Korall S.R.L. Satu Mare

    Satu-Mare, 440055
    Romania

    Site Not Available

  • Clinica Universitaria de Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Centro Periferico De Especialidades Bola Azul

    Almeria, 04009
    Spain

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario San Cecilio

    Granada, 18016
    Spain

    Site Not Available

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Sevilla, 41003
    Spain

    Site Not Available

  • Hospital Clínico de Valladolid

    Valladolid, 47003
    Spain

    Site Not Available

  • Chang Gung Memorial Hospital - Kaoshiung Branch

    Kaohsiung City, 833
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaoshiung, 807
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung City, 404328
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung City, 407
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan City, 704
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital Linkou

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • Cahaba Research

    Pelham, Alabama 35124
    United States

    Site Not Available

  • Velocity Clinical Research-Phoenix

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • AES Tucson DRS

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Woodland Int. Research Group

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Velocity Clin Res-Chula Vista

    Chula Vista, California 91911
    United States

    Site Not Available

  • John Muir Physicians Network

    Concord, California 94520
    United States

    Site Not Available

  • Diabetes & Endocrine Specialists - La Mesa

    La Mesa, California 91942
    United States

    Site Not Available

  • Velocity Clin Research LA

    Los Angeles, California 90057
    United States

    Site Not Available

  • Desert Oasis Healthcare

    Palm Springs, California 92262
    United States

    Site Not Available

  • Velocity Clin Res - Panorama

    Panorama City, California 91402
    United States

    Site Not Available

  • Velocity Clin Res Santa Ana

    Santa Ana, California 92704
    United States

    Site Not Available

  • Velocity Clin Res - Panorama

    Van Nuys, California 91405
    United States

    Site Not Available

  • Optumcare Colorado Springs

    Colorado Springs, Colorado 80906
    United States

    Site Not Available

  • FEME Medical LLC

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Tampa Bay Medical Research

    Clearwater, Florida 33761
    United States

    Site Not Available

  • AGA Clinical Trial

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Bioclinical Research Alliance

    Miami, Florida 33155
    United States

    Site Not Available

  • Clinical Trial Services Corp

    Miami, Florida 33144
    United States

    Site Not Available

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • South Broward Research LLC

    Miramar, Florida 33027
    United States

    Site Not Available

  • West Orange Endocrinology

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Optimal Research Sites

    Orange City, Florida 32763
    United States

    Site Not Available

  • Javara Inc. / Privia Medical Group Georgia LLC

    Fayetteville, Georgia 30214
    United States

    Site Not Available

  • Clinical Invest Special_Gurnee

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Iowa Diabetes & Endo Res Ctr

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Cotton-Oneill Diabetes and End

    Topeka, Kansas 66606-2806
    United States

    Site Not Available

  • AES Minneapolis DRS

    Richfield, Minnesota 55423
    United States

    Site Not Available

  • Velocity Clin Res Gulfport

    Gulfport, Mississippi 39503
    United States

    Site Not Available

  • AES St. Louis DRS

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Univ of Nebraska Medical CTR

    Omaha, Nebraska 68198-3020
    United States

    Site Not Available

  • Velocity Clin Res Albuquerque

    Albuquerque, New Mexico 87107
    United States

    Site Not Available

  • Albany Medical College

    Albany, New York 12203
    United States

    Site Not Available

  • Carteret Medical Group

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Piedmont Healthcare/Research

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Lillestol Research LLC

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Triad Research Institute

    Norman, Oklahoma 73072
    United States

    Site Not Available

  • Circuit Clinical - PMSI

    Pottstown, Pennsylvania 19464
    United States

    Site Not Available

  • Clinical Res Collaborative

    Cumberland, Rhode Island 02864
    United States

    Site Not Available

  • Velocity Clin Res Providence

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Velocity Clin Res Gaffney

    Gaffney, South Carolina 29340
    United States

    Site Not Available

  • Holston Medical Group

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Clinical Research Associates

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Velocity Clin Res Austin

    Austin, Texas 78759
    United States

    Site Not Available

  • AES Dallas DFW DRS

    Dallas, Texas 75234
    United States

    Site Not Available

  • UT Southwestern Medical Center - Lingvay

    Dallas, Texas 75390
    United States

    Site Not Available

  • Discovery MM Services - Houston - Broadway Street

    Houston, Texas 77061
    United States

    Site Not Available

  • Juno Research, LLC_Houston

    Houston, Texas 77040
    United States

    Site Not Available

  • PlanIt Research, PLLC

    Houston, Texas 77079
    United States

    Site Not Available

  • Sante Clinical Research

    Kerrville, Texas 78028
    United States

    Site Not Available

  • Aeres Clinical Research

    Laredo, Texas 78041
    United States

    Site Not Available

  • RGV Endocrine Center

    McAllen, Texas 78503
    United States

    Site Not Available

  • Privia Health Javara Clin Res.

    Stephenville, Texas 76401
    United States

    Site Not Available

  • Chrysalis Clinical Research

    Saint George, Utah 84790
    United States

    Site Not Available

  • J.Lewis Research Inc

    Salt Lake City, Utah 84109
    United States

    Site Not Available

  • TPMG Clinical Research

    Newport News, Virginia 23606
    United States

    Site Not Available

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