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
NCT ID: NCT06534411
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1023 participants
INTERVENTIONAL
2024-11-05
2026-07-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CagriSema
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 8-week dose escalation period until target dose of CagriSema is achieved and maintained for 52 weeks.
Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
Tirzepatide
Participants will receive once-weekly s.c injections of tirzepatide at escalating dose in a 4-week dose escalating period and maintained up to 56 weeks.
Tirzepatide
Participants will receive once-weekly tirzepatide subcutaneously.
Interventions
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Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
Tirzepatide
Participants will receive once-weekly tirzepatide subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* 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 days before screening.
* Stable daily dose(s) \>= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose 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. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Exclusion Criteria
* Renal impairment with estimated Glomerular Filtration Rate less than \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Diab Serwis Popenda Spółka Jawna
Chorzów, , Poland
Cahaba Research
Pelham, Alabama, United States
Velocity Clinical Research-Phoenix
Phoenix, Arizona, United States
AES Tucson DRS
Tucson, Arizona, United States
Woodland Int. Research Group
Little Rock, Arkansas, United States
Velocity Clin Res-Chula Vista
Chula Vista, California, United States
John Muir Physicians Network
Concord, California, United States
Diabetes & Endocrine Specialists - La Mesa
La Mesa, California, United States
Velocity Clin Research LA
Los Angeles, California, United States
Desert Oasis Healthcare
Palm Springs, California, United States
Velocity Clin Res Santa Ana
Santa Ana, California, United States
Velocity Clin Res - Panorama
Van Nuys, California, United States
Optumcare Clinical Trials,LLC-Golden
Colorado Springs, Colorado, United States
FEME Medical LLC
Washington D.C., District of Columbia, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
AGA Clinical Trial
Hialeah, Florida, United States
Clinical Trial Services Corp
Miami, Florida, United States
Bioclinical Research Alliance
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Optimal Research Sites
Orange City, Florida, United States
Javara Inc. / Privia Medical Group Georgia LLC
Fayetteville, Georgia, United States
Clinical Invest Special_Gurnee
Gurnee, Illinois, United States
Iowa Diabetes & Endo Res Ctr
West Des Moines, Iowa, United States
Cotton-Oneill Diabetes and End
Topeka, Kansas, United States
AES Minneapolis DRS
Richfield, Minnesota, United States
Velocity Clin Res Gulfport
Gulfport, Mississippi, United States
AES St. Louis DRS
St Louis, Missouri, United States
Univ of Nebraska Medical CTR
Omaha, Nebraska, United States
Velocity Clin Res Albuquerque
Albuquerque, New Mexico, United States
Albany Medical College
Albany, New York, United States
Carteret Medical Group
Morehead City, North Carolina, United States
Piedmont Healthcare/Research
Statesville, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Triad Research Institute
Norman, Oklahoma, United States
Circuit Clinical - PMSI
Pottstown, Pennsylvania, United States
Clinical Res Collaborative
Cumberland, Rhode Island, United States
Velocity Clin Res Providence
East Greenwich, Rhode Island, United States
Velocity Clin Res Gaffney
Gaffney, South Carolina, United States
Holston Medical Group
Kingsport, Tennessee, United States
Clinical Research Associates
Nashville, Tennessee, United States
Velocity Clin Res Austin
Austin, Texas, United States
AES Dallas DFW DRS
Dallas, Texas, United States
UT Southwestern Medical Center - Lingvay
Dallas, Texas, United States
JCCT- Juno NW Houston
Houston, Texas, United States
Discovery MM Services - Houston - Broadway Street
Houston, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
Aeres Clinical Research
Laredo, Texas, United States
RGV Endocrine Center
McAllen, Texas, United States
Privia Health Javara Clin Res.
Stephenville, Texas, United States
J.Lewis Research Inc
Salt Lake City, Utah, United States
Chrysalis Clinical Research
St. George, Utah, United States
TPMG Clinical Research
Newport News, Virginia, United States
Centro Médico CIMEL
Lanús Este, Buenos Aires, Argentina
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Fundación CESIM
Santa Rosa, La Pampa Province, Argentina
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucuimán, Tucumán Province, Argentina
IMOBA
City of Buenos Aires, , Argentina
Centro de Investigaciones Metabólicas
City of Buenos Aires, , Argentina
Instituto de Investigaciones Clinicas San Nicolás
San Nicolás, , Argentina
Paratus Clinical
Bruce, Australian Capital Territory, Australia
Hunter Diabetes Centre
Merewether, New South Wales, Australia
Austrials
St Leonards, New South Wales, Australia
Momentum Clinical Research
St Leonards, New South Wales, Australia
Roger Chih Yu Chen
Sydney, New South Wales, Australia
Townsville University Hospital
Douglas, Queensland, Australia
Paratus Clinical
Herston, Queensland, Australia
Centro de Diabetes Curitiba
Curitiba, Paraná, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande do Sul, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, Brazil
Hilltop Medical Clinic
Surrey, British Columbia, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Centricity Research Brampton
Brampton, Ontario, Canada
Centricity Research Etobicoke
Etobicoke, Ontario, Canada
Wharton Med Clin Trials
Hamilton, Ontario, Canada
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, Canada
Diabetes Heart Research Centre
Toronto, Ontario, Canada
Ctr de rech Clin de Laval
Laval, Quebec, Canada
Alpha Recherche Clinique - Clinique de Levis
Lévis, Quebec, Canada
Centre Medical Acadie
Montreal, Quebec, Canada
Ctr de Med Metab de Lanaudiere
Terrebonne, Quebec, Canada
Diex Recherche Victoriaville
Victoriaville, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, , Canada
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, , Germany
Universitätsklinikum Essen - Klinik für Endokrinologie, Diabetologie und Stoffwechsel
Essen, , Germany
Praxis am Markt Dr. Becker
Essen, , Germany
Universitätsklinikum Freiburg - Innere Medizin II
Freiburg im Breisgau, , Germany
Wendisch/Dahl Hamburg (DZHW)
Hamburg, , Germany
Medicover Neuroendokrinologie MVZ München
München, , Germany
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
Münster, , Germany
Zentrum für klinische Studien Allgäu Oberschwaben
Wangen, , Germany
Alexandra General Hospital, Therapeutic Clinic
Athens, Attica, Greece
General Hospital Venizeleio-Pananeio - Diabetic Clinic
Heraklion, Crete, Greece
Evangelismos Hospital
Athens, , Greece
Iatriko Athinon 'Palaiou Falirou'
Athens, , Greece
"Laiko" General Hospital of Athens
Goudi/Athens, , Greece
University General Hospital of Ioannina,Internal Medicine
Ioannina, , Greece
General Hospital of Thessaloniki 'G. Gennimatas
Thessaloniki, , Greece
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, , Greece
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
Szeged, Csongrád-Csanád, Hungary
Komáromi Selye János Kórház
Komárom, Komárom-Esztergom, Hungary
QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft
Budapest, Pest County, Hungary
Óbudai Egészségügyi Centrum
Budapest, Pest County, Hungary
Szőcs Depot Egészségügyi Szolgáltató Kft.
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, , Hungary
PVN Kutato Kft.
Budapest, , Hungary
MED-TIMA Kft.
Budapest, , Hungary
Észak-Pesti Centrumkórház Honvédkórház
Budapest, , Hungary
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, India
Ramaiah Memorial Hospital
Bengaluru, Karnataka, India
Excel Endocrine Centre
Kolhāpur, Maharashtra, India
Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha
Wardha, Maharashtra, India
All India Institute of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, India
Jawahar Lal Nehru Govt. Medical College
Ajmer, Rajasthan, India
SMS Hospital
Jaipur, Rajasthan, India
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan, India
Arthur Asirvatham hospital,
Madurai, Tamil Nadu, India
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Puducherry, Tamil Nadu, India
AIG Hospitals,Hyderabad
Hyderabad, Telangana, India
Udyaan Health Care
Lucknow, Uttar Pradesh, India
IPGME&R and SSKM Hospital
Kolkata, West Bengal, India
Clalit sick fund Herzeliya
Herzeliya, Israel, Israel
Rambam MC - Diabetes and obesity center of excellence
Haifa, , Israel
Wolfson MC - Diabetes Clinic
Holon, , Israel
Hadassah Ein Karam MC - Diabetes Unit
Jerusalem, , Israel
Rabin MC Beilinson - Endo unit
Petah Tikva, , Israel
Sourasky MC - Institute of Endocrinology, metabolism and hypertension
Tel Aviv, , Israel
Sheba MC - Endocrinology Clinic
Tel Litwinsky, , Israel
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , Poland
Specjalistyczny Gabinet Diabetologiczny Rumianowski Radosław
Gorzów Wielkopolski, , Poland
Centrum Terapii Wspolczesnej - J.M. Jasnorzewska S.K.A.
Lodz, , Poland
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Olsztyn, , Poland
Kiepury Clinic MALGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POLOZNICZA
Sosnowiec, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
Zabrze, , Poland
Diabdana S.R.L.
Oradea, Bihor County, Romania
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
Bucharest, Bucurestii, Romania
CMI Dr Pop Lavinia
Baia Mare, Maramureş, Romania
Sc Mediab Srl
Târgu Mureş, Mureș County, Romania
SC Nutrilife SRL
Bucharest, , Romania
Diabet Med SRL
Bucharest, , Romania
Sanamed Hospital SRL
Bucharest, , Romania
Clinica Korall S.R.L. Satu Mare
Satu Mare, , Romania
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Centro Periferico De Especialidades Bola Azul
Almería, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Universitario San Cecilio
Granada, , Spain
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Seville, , Spain
Hospital Clínico de Valladolid
Valladolid, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaoshiung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital Linkou
Taoyuan, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
Countries
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Other Identifiers
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U1111-1300-2590
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509600-15
Identifier Type: OTHER
Identifier Source: secondary_id
NN9388-7741
Identifier Type: -
Identifier Source: org_study_id
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