NCT06323174CompletedPhase 3
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Diet and Exercise
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 189 (actual)
- First submitted
- 15 Mar 2024
- Start date
- 19 Mar 2024
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT06323174
- EU CT number
- 2022-502677-42-00
- EudraCT number
- 2022-502677-42
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 189
- From 19 Mar 2024 to the primary completion date, 1 Oct 2025
- 50 sites in 7 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
- Treatment with any medication for the indication of diabetes or obesity within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
- History of use of any injectable therapy for diabetes or obesity. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
- 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 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
- Age 18 years or above at the time of signing the informed consent
- Diagnosed with type 2 diabetes \>=30 days before screening
- HbA1c 7.0-9.5 percent (53-80 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening
- Body mass index (BMI) \>=23 kilograms 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 (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese People's Liberation Army General Hospital-Endocrinology Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Ji'nan | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University-Endocrinology Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Affiliated Hospital of Jiangsu University-Endocrinology Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
| Szent Margit Rendelointezet Nonprofit Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Completed |
| PVN Kutato Kft. Coordinator of this site? Confirm its status | Budapest X | Hungary | Completed |
| Belinus Bt. Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Borbanya Praxis Egeszsegugyi Kft Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Completed |
| Azienda Ospedaliera Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Completed |
| Azienda Ospedaliera Universitaria Mater Domini Coordinator of this site? Confirm its status | Catanzaro | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Renew Clinic Sp. z o.o. Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Osteo-Medic s.c. A. Racewicz, J. Supronik Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Centrum Medyczne Medyk Sp. z o.o. Coordinator of this site? Confirm its status | Rzeszow | Poland | Completed |
| Nbr Polska Tomasz Klodawski Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Velocity Nova Sp. z o.o. Coordinator of this site? Confirm its status | Zamość | Poland | Completed |
| Clinical hospital center Bezanijska Kosa Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Clinical Hospital Centre Zemun Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| CHC Zvezdara, Clinical department for endocrinology Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Policlinic for diabetes Coordinator of this site? Confirm its status | Zaječar | Serbia | Unknown status |
| King Abdulaziz Hospital-Al Ahsa-National Guard Coordinator of this site? Confirm its status | Al Ahsa | Saudi Arabia | Unknown status |
| National Guard Hospital - Jeddah Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Unknown status |
| King Fahad Medical City Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| King Salman Bin Abdulaziz Hospital Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| King Khaled University Hospital,King Saud Univ. Med. City Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Unknown status |
| Amarillo Medical Specialists Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Elligo Clin Res Centre Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Brigham & Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Headlands Research - Brownsville Coordinator of this site? Confirm its status | Brownsville | United States | Unknown status |
| Velocity Clinical Res-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Encore Medical Research LLC Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Nat Res Inst Huntington Park Coordinator of this site? Confirm its status | Huntington Park | United States | Unknown status |
| Holston Medical Group. Coordinator of this site? Confirm its status | Kingsport | United States | Unknown status |
| TPMG Clinical Research Coordinator of this site? Confirm its status | Newport News | United States | Unknown status |
| Alliance for Multispec Res Coordinator of this site? Confirm its status | Newton | United States | Unknown status |
| Valley Clinical Trials, Inc. Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| Headlands Research Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Summit Research Network Oregon Inc. Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Northeast Clinical Research of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Southern California Dermatology Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
| Consano Clinical Research, LLC Coordinator of this site? Confirm its status | Shavano Park | United States | Unknown status |
| Sugar Lakes Family Practice, PA Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Arcturus HC PLC Troy Med Res Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| Valley Diab. & Endo Comp Ctr Coordinator of this site? Confirm its status | Weslaco | United States | Unknown status |
| Encore Medical Research of Weston Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
| Southgate Medical Group, LLP Coordinator of this site? Confirm its status | West Seneca | United States | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.