NCT06534411CompletedPhase 3
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
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1023 (actual)
- First submitted
- 30 Jul 2024
- Start date
- 5 Nov 2024
- Primary completion date
- 2 Jun 2026
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT06534411
- EU CT number
- 2023-509600-15-00
- EudraCT number
- 2023-509600-15
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1023
- From 5 Nov 2024 to the primary completion date, 2 Jun 2026
- 161 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed.
- 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.
Lab values
- 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.
Other
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
Who the study is looking for
- 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 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (161)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IMOBA Coordinator of this site? Confirm its status | City of Buenos Aires | Argentina | Unknown status |
| Centro de Investigaciones Metabólicas Coordinator of this site? Confirm its status | City of Buenos Aires | Argentina | Unknown status |
| Centro Médico CIMEL Coordinator of this site? Confirm its status | Lanús Este | Argentina | Unknown status |
| Centro de Investigaciones Medicas Mar Del Plata Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Centro de Investigaciones Médicas Tucumán Coordinator of this site? Confirm its status | San Miguel de Tucuimán | Argentina | Unknown status |
| Instituto de Investigaciones Clinicas San Nicolás Coordinator of this site? Confirm its status | San Nicolás | Argentina | Unknown status |
| Fundación CESIM Coordinator of this site? Confirm its status | Santa Rosa | Argentina | Unknown status |
| Paratus Clinical Coordinator of this site? Confirm its status | Bruce | Australia | Unknown status |
| Townsville University Hospital Coordinator of this site? Confirm its status | Douglas | Australia | Unknown status |
| Paratus Clinical Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Hunter Diabetes Centre Coordinator of this site? Confirm its status | Merewether | Australia | Unknown status |
| Austrials Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
| Momentum Clinical Research St Leonards Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
| Roger Chih Yu Chen Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Centro de Diabetes Curitiba Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda. Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| CPQuali Pesquisa Clínica Ltda Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Centricity Research Brampton Endocrinology Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| Centricity Research Etobicoke Endocrinology Coordinator of this site? Confirm its status | Etobicoke | Canada | Unknown status |
| Wharton Medical Clinic Clinical Trials (Hamilton) Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Ctr de recherche Clinique de Laval Coordinator of this site? Confirm its status | Laval | Canada | Unknown status |
| Alpha Recherche Clinique - Clinique de Levis Coordinator of this site? Confirm its status | Lévis | Canada | Unknown status |
| G.A. Research Associates, Ltd. Coordinator of this site? Confirm its status | Moncton | Canada | Unknown status |
| Centre Medical Acadie Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Centre de Recherche Saint-Louis Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| London Road Diagnostic Clinic and Medical Centre Coordinator of this site? Confirm its status | Sarnia | Canada | Unknown status |
| Hilltop Medical Clinic Coordinator of this site? Confirm its status | Surrey | Canada | Unknown status |
| Ctr de Med Metab de Lanaudiere Coordinator of this site? Confirm its status | Terrebonne | Canada | Unknown status |
| Diabetes Heart Research Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Diex Recherche Victoriaville Coordinator of this site? Confirm its status | Victoriaville | Canada | Unknown status |
| Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Completed |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Praxis am Markt Dr. Becker Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Completed |
| Wendisch/Dahl Hamburg Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Medicover Neuroendokrinologie MVZ Coordinator of this site? Confirm its status | Muenchen | Germany | Completed |
| Schwerpunktpraxis für Diabetes und Ernährungsmedizin Coordinator of this site? Confirm its status | Münster | Germany | Completed |
| Zentrum für klinische Forschung Allgäu-Oberschwaben Coordinator of this site? Confirm its status | Wangen | Germany | Completed |
| Centro Periférico de Especialidades Bola Azul Coordinator of this site? Confirm its status | Almería | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Completed |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Completed |
| Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Completed |
| Evangelismos S A Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| General Hospital Venizeleio Coordinator of this site? Confirm its status | Heraklion | Greece | Completed |
| University General Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Completed |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Paleo Faliro | Greece | Completed |
| General Hospital Of Thessloniki G Gennimatas Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Ippokratio General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Szőcs Depot Egészségügyi Szolgáltató Kft. Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Qualiclinic Kft. Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Obudai Egeszseguegyi Centrum Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Completed |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Completed |
| ClinDiab Kft. Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Completed |
| PVN Kutato Kft. Coordinator of this site? Confirm its status | Budapest X | Hungary | Completed |
| Med-Tima Kft. Coordinator of this site? Confirm its status | Budapest XIII | Hungary | Completed |
| Central Hospital Of Northern Pest Military Hospital Coordinator of this site? Confirm its status | Budapest XIII | Hungary | Completed |
| Komaromi Selye Janos Korhaz Coordinator of this site? Confirm its status | Komárom | Hungary | Completed |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Completed |
| Rambam MC - Diabetes and obesity center of excellence Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Clalit sick fund Herzeliya Coordinator of this site? Confirm its status | Herzeliya | Israel | Unknown status |
| Wolfson MC - Diabetes Clinic Coordinator of this site? Confirm its status | Holon | Israel | Unknown status |
| Hadassah Ein Karam MC - Diabetes Unit Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin MC Beilinson - Endo unit Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Sourasky MC - Institute of Endocrinology, metabolism and hypertension Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Sheba MC - Endocrinology Clinic Coordinator of this site? Confirm its status | Tel HaShomer | Israel | Unknown status |
| Jawahar Lal Nehru Govt. Medical College Coordinator of this site? Confirm its status | Ajmer | India | Unknown status |
| Ramaiah Memorial Hospital Coordinator of this site? Confirm its status | Bengaluru | India | Unknown status |
| Endolife Specialty Hospitals Coordinator of this site? Confirm its status | Guntur | India | Unknown status |
| AIG Hospitals,Hyderabad Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Diabetes, Thyroid and Endocrine Centre Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| SMS Hospital Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| Excel Endocrine Centre Coordinator of this site? Confirm its status | Kolhāpur | India | Unknown status |
| IPGME&R and SSKM Hospital Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Udyaan Health Care Coordinator of this site? Confirm its status | Lucknow | India | Unknown status |
| Arthur Asirvatham hospital, Coordinator of this site? Confirm its status | Madurai | India | Unknown status |
| All India Institute of Medical Sciences(AIIMS) Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Coordinator of this site? Confirm its status | Puducherry | India | Unknown status |
| Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha Coordinator of this site? Confirm its status | Wardha | India | Unknown status |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Diab Serwis Popenda Sp. j. Coordinator of this site? Confirm its status | Chorzow | Poland | Completed |
| Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski Coordinator of this site? Confirm its status | Gorzów Wielkopolski | Poland | Completed |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Coordinator of this site? Confirm its status | Olsztyn | Poland | Completed |
| Kiepury Clinic MALGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POLOZNICZA Coordinator of this site? Confirm its status | Sosnowiec | Poland | Completed |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Zabrze | Poland | Completed |
| Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia Coordinator of this site? Confirm its status | Baia Mare | Romania | Completed |
| Nutrilife S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Diabet Med S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Sanamed Hospital S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Diabdana S.R.L. Coordinator of this site? Confirm its status | Oradea | Romania | Completed |
| Clinica Korall S.R.L. Coordinator of this site? Confirm its status | Satu Mare | Romania | Completed |
| Mediab S.R.L. Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Completed |
| Chang Gung Memorial Hospital - Kaohsiung Branch Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaoshiung | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital, Linkou Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Chang Gung Memorial Hospital Linkou Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
| Albany Medical College Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Velocity Clin Res Albuquerque Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Velocity Clin Res Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Velocity Clin Res-Chula Vista Coordinator of this site? Confirm its status | Chula Vista | United States | Unknown status |
| Tampa Bay Medical Research Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Optumcare Clinical Trials,LLC-Golden Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| John Muir Physicians Network Coordinator of this site? Confirm its status | Concord | United States | Unknown status |
| Clinical Res Collaborative Coordinator of this site? Confirm its status | Cumberland | United States | Unknown status |
| Synexus Clin Res Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| UT Southwestern Med Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Velocity Clin Res Providence Coordinator of this site? Confirm its status | East Greenwich | United States | Unknown status |
| Lillestol Research, LLC Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Javara Inc. / Privia Medical Group Georgia LLC Coordinator of this site? Confirm its status | Fayetteville | United States | Unknown status |
| Velocity Clin Res Gaffney Coordinator of this site? Confirm its status | Gaffney | United States | Unknown status |
| Velocity Clin Res Gulfport Coordinator of this site? Confirm its status | Gulfport | United States | Unknown status |
| Clinical Invest Special_Gurnee Coordinator of this site? Confirm its status | Gurnee | United States | Unknown status |
| AGA Clinical Trial Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| PlanIt Research, PLLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Synergy Groups Medical Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| JCCT- Juno NW Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Sante Clinical Research Coordinator of this site? Confirm its status | Kerrville | United States | Unknown status |
| Holston Medical Group. Coordinator of this site? Confirm its status | Kingsport | United States | Unknown status |
| Diabetes & Endocrine Specialists - La Mesa Coordinator of this site? Confirm its status | La Mesa | United States | Unknown status |
| Aeres Clinical Research Coordinator of this site? Confirm its status | Laredo | United States | Unknown status |
| Woodland Int. Research Group Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Velocity Clin Research LA Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Biopharma Informatic, LLC Coordinator of this site? Confirm its status | McAllen | United States | Unknown status |
| Bioclinical Research Alliance Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| New Horizon Research Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| South Broward Research LLC Coordinator of this site? Confirm its status | Miramar | United States | Unknown status |
| Carteret Medical Group Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| Clinical Research Associates Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| TPMG Clinical Research Coordinator of this site? Confirm its status | Newport News | United States | Unknown status |
| Triad Research Institute Coordinator of this site? Confirm its status | Norman | United States | Unknown status |
| West Orange Endocrinology Coordinator of this site? Confirm its status | Ocoee | United States | Unknown status |
| Univ of Nebraska Medical CTR Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Orange City | United States | Unknown status |
| Desert Oasis Healthcare Coordinator of this site? Confirm its status | Palm Springs | United States | Unknown status |
| Cahaba Research Coordinator of this site? Confirm its status | Pelham | United States | Unknown status |
| Center for Diab,Obes & Metab Coordinator of this site? Confirm its status | Pembroke Pines | United States | Unknown status |
| Velocity Clinical Research, Phoenix Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Circuit Clinical - PMSI Coordinator of this site? Confirm its status | Pottstown | United States | Unknown status |
| AES Minneapolis DRS Coordinator of this site? Confirm its status | Richfield | United States | Unknown status |
| J.Lewis Research Inc Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Velocity Clin Res Santa Ana Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
| Piedmont Healthcare/Research Coordinator of this site? Confirm its status | Statesville | United States | Unknown status |
| Privia Health Javara Clin Res. Coordinator of this site? Confirm its status | Stephenville | United States | Unknown status |
| Chrysalis Clinical Research Coordinator of this site? Confirm its status | St. George | United States | Unknown status |
| AES St. Louis DRS Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Cotton-Oneill Diabetes and End Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| AES Tucson DRS Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Velocity Clin Res - Panorama Coordinator of this site? Confirm its status | Van Nuys | United States | Unknown status |
| FEME Medical LLC Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Iowa Diabetes & Endo Res Ctr Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.