NCT05394519CompletedPhase 3
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1200 (actual)
- First submitted
- 24 May 2022
- Start date
- 1 Feb 2023
- Primary completion date
- 28 Jan 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05394519
- EU CT number
- 2023-506931-13-00
- EudraCT number
- 2021-005121-24
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1200
- From 1 Feb 2023 to the primary completion date, 28 Jan 2025
- 163 sites in 13 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 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 (eGFR) below 30 mL/min/1.73 m\^2, as measured by the central laboratory at screening
Who the study is looking for
- Male or female
- Age above or equal to 18 years at the time of signing informed consent
- BMI greather than or equal to 27.0 kg/m\^2
- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
- Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
- Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
- HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (163)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Graz Coordinator of this site? Confirm its status | Graz | Austria | Completed |
| Ordination Dr. Evelyn Fliesser-Görzer Coordinator of this site? Confirm its status | St. Stefan ob Stainz | Austria | Completed |
| Imed19-privat Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Klinik Landstrabe Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Dr. Harpreet Bajaj Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| LMC Clin Res Inc. Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| C-endo Diab Endo Clin Calgery Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Centricity Research Etobicoke Endocrinology Coordinator of this site? Confirm its status | Etobicoke | Canada | Unknown status |
| Wharton Med Clin Trials Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Milestone Research Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Centre Medical Acadie Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Commonwealth Medical Clinic Coordinator of this site? Confirm its status | Mount Pearl | Canada | Unknown status |
| LMC Research Inc. Ottawa Coordinator of this site? Confirm its status | Nepean | Canada | Unknown status |
| Centricity Res Pointe-Claire Coordinator of this site? Confirm its status | Pointe-Claire | Canada | Unknown status |
| LMC Clin Rsrch Inc. (Montreal) Coordinator of this site? Confirm its status | Saint-Laurent | Canada | Unknown status |
| Diabetes Heart Research Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Dr. M.B. Jones Inc Coordinator of this site? Confirm its status | Victoria | Canada | Unknown status |
| MVZ DiaMedicum Bad Mergentheim GmbH Coordinator of this site? Confirm its status | Bad Mergentheim | Germany | Completed |
| Zentrum fuer klinische Studien Suedbrandenburg GmbH Coordinator of this site? Confirm its status | Elsterwerda | Germany | Completed |
| InnoDiab Forschung Gmbh Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Wendisch/Dahl Hamburg Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Ambenet GmbH Das Ambulante Behandlungsnetz Coordinator of this site? Confirm its status | Leipzig | Germany | Completed |
| Institut fuer Diabetesforschung Muenster GmbH Coordinator of this site? Confirm its status | Muenster | Germany | Completed |
| Zentrum für klinische Studien Alexander Segner Coordinator of this site? Confirm its status | St. Ingbert-Oberwürzbach | Germany | Completed |
| Erlinger Coordinator of this site? Confirm its status | Stuttgart | Germany | Completed |
| Zentrum für klinische Forschung Allgäu-Oberschwaben Coordinator of this site? Confirm its status | Wangen | Germany | Completed |
| Crouch Oak Family Practice Coordinator of this site? Confirm its status | Addlestone | United Kingdom | Unknown status |
| Antrim Area Hospital Coordinator of this site? Confirm its status | Antrim | United Kingdom | Unknown status |
| Layton Medical Centre Coordinator of this site? Confirm its status | Blackpool | United Kingdom | Unknown status |
| The Health Centre Coordinator of this site? Confirm its status | Bradford on Avon | United Kingdom | Unknown status |
| Southmead Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Hathaway Medical Centre Coordinator of this site? Confirm its status | Chippenham | United Kingdom | Unknown status |
| Harrogate District Hospital Coordinator of this site? Confirm its status | Harrogate | United Kingdom | Unknown status |
| HMC Health - Heston Coordinator of this site? Confirm its status | Hounslow | United Kingdom | Unknown status |
| Leicester General Hospital Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Kiltearn Medical Centre Coordinator of this site? Confirm its status | Nantwich | United Kingdom | Unknown status |
| Clifton Medical Centre Coordinator of this site? Confirm its status | Rotherham | United Kingdom | Unknown status |
| Ashfields Primary Care Centre Coordinator of this site? Confirm its status | Sandbach | United Kingdom | Unknown status |
| Staploe Medical Centre Coordinator of this site? Confirm its status | Soham | United Kingdom | Unknown status |
| Joint Clinical Research Facility - Swansea Coordinator of this site? Confirm its status | Swansea | United Kingdom | Unknown status |
| Musgrove Park Hospital Coordinator of this site? Confirm its status | Taunton | United Kingdom | Unknown status |
| Royal Cornwall Hospital (Treliske) Coordinator of this site? Confirm its status | Truro | United Kingdom | Unknown status |
| Albany House Medical Centre Coordinator of this site? Confirm its status | Wellingborough | United Kingdom | Unknown status |
| Szőcs Depot Egészségügyi Szolgáltató Kft. Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | 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 |
| Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet Coordinator of this site? Confirm its status | Szolnok | Hungary | Completed |
| Connolly Hospital Coordinator of this site? Confirm its status | Dublin 15 | Ireland | Completed |
| St Vincent's University Hospital Coordinator of this site? Confirm its status | Dublin 4 | Ireland | Completed |
| Mater Misericordiae University Hospital Coordinator of this site? Confirm its status | Dublin 7 | Ireland | Completed |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Completed |
| National University Of Ireland Coordinator of this site? Confirm its status | Galway | Ireland | Completed |
| HCG Hospitals Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| All India Institute of Medical Sciences_Delhi Coordinator of this site? Confirm its status | Ansārinagar | India | Unknown status |
| Ramaiah Memorial Hospital Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Post Graduate Institute of Medical Education & Research_Chandigarh Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
| Apollo Research & Innovation (ARI) Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| Madras Diabetes Research Foundation Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| Gleneagles Hospitals Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| SMS Medical College & Hospital Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| J K Lon Hospital, SMS Medical College & Attached Hospitals 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 |
| Apollo Multispeciality Hospitals limited Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Apollo Multispeciality Hospital, Kolkata Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Calicut Medical College Coordinator of this site? Confirm its status | Kozhikode | India | Unknown status |
| BYL Nair Hospital and T N Medical College Department of endo Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Seth GS medical college and KEM Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Sunil's Diabetes Care n' Research Centre Pvt Ltd Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| Lady Hardinge Medical College Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Noble Hospitals Pvt Ltd. Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Indian Institute of Diabetes Coordinator of this site? Confirm its status | Thiruvnanthapuram | India | Unknown status |
| TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology Coordinator of this site? Confirm its status | Aichi | Japan | Unknown status |
| Tokuyama clinic_Diabetic internal medicine Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Naka Kinen Clinic_Internal medicine Coordinator of this site? Confirm its status | Ibaraki | Japan | Unknown status |
| Osaka Nishiumeda Clinic_Diabetes Internal Medicine Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Takatsuki Red Cross Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Osaka University Hospital_Metabolic Medicine Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Hospital Ampang Coordinator of this site? Confirm its status | Ampang, Selangor | Malaysia | Unknown status |
| Hospital Canselor Tuanku Muhriz UKM Coordinator of this site? Confirm its status | Cheras | Malaysia | Unknown status |
| Hospital Universiti Sains Malaysia Coordinator of this site? Confirm its status | Kota Bharu | Malaysia | Unknown status |
| Sarawak General Hospital Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Hospital Melaka Coordinator of this site? Confirm its status | Malacca | Malaysia | Unknown status |
| Hospital Miri Coordinator of this site? Confirm its status | Miri | Malaysia | Unknown status |
| Hospital Putrajaya Coordinator of this site? Confirm its status | Putrajaya | Malaysia | Unknown status |
| Hospital Tuanku Jaafar Coordinator of this site? Confirm its status | Seremban | Malaysia | Unknown status |
| Hospital Seri Manjung Coordinator of this site? Confirm its status | Seri Manjung | Malaysia | Unknown status |
| University Technology MARA (UiTM) - Sg Buloh Coordinator of this site? Confirm its status | Sungai Buloh | Malaysia | Unknown status |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Gabinet Leczenia Otyłości i Chorób Dietozależnych Coordinator of this site? Confirm its status | Białystok | Poland | Completed |
| Centrum Kardiometaboliczne Gierach-Med Marcin Gierach Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Linden Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Klinika Bellamed Coordinator of this site? Confirm its status | Elblag | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Salvia Lekston I Madej Sp. J. Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j. Coordinator of this site? Confirm its status | Legnica | Poland | Completed |
| Terpa Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Trialmed Sp. z o. o. Coordinator of this site? Confirm its status | Piotrkow Trybunalski | Poland | Completed |
| Centrum Zdrowia Metabolicznego Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Instytut Diabetologii.sp.z.o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKP Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Med Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Ponce Med School Found Inc Coordinator of this site? Confirm its status | Ponce | Puerto Rico | Unknown status |
| Ramathibodi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| King Chulalongkorn Memorial Hospital_Bangkok Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Rajavithi Hospital_Diabetes and Endocrinology Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| King Chulalongkorn Memorial Hospital_Endocrinology Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Siriraj Hospital_Dept Endocrinology Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Rajavithi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Siriraj Hospital_Bangkoknoi, Bangkok Coordinator of this site? Confirm its status | Bangkoknoi, Bangkok | Thailand | Unknown status |
| Srinagarind Hospital Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
| Thammasat Hospital_Cardiology Coordinator of this site? Confirm its status | Pathum Thani | Thailand | Unknown status |
| AMC Community Endocrinology Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Amarillo Med Spec LLP Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Texas Diab & Endo, P.A. Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Pennington Biom Res Ctr Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Northern Pines Hlth Ctr, PC Coordinator of this site? Confirm its status | Buckley | United States | Unknown status |
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