NCT06221969CompletedPhase 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 With or Without an SGLT2 Inhibitor
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
This study will look at how well CagriSema helps people 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 medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1024 (actual)
- First submitted
- 15 Jan 2024
- Start date
- 16 Jan 2024
- Primary completion date
- 4 Mar 2026
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT06221969
- EU CT number
- 2023-503789-21-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1024
- From 16 Jan 2024 to the primary completion date, 4 Mar 2026
- 195 sites in 8 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 other than stated in the inclusion criteria 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.
- 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 \< 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 ≥ 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 with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor.
- HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
- Body mass index (BMI) of ≥ 30.0 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 (195)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OMI- Organización Médica de Investigación Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CICEMO- Consultorio de Investigación Clínica EMO Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Instituto de Investigaciones Metabolicas (IDIM) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Cedic - Centro de Investigacion Clinica Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Centro de Investigación Clínica Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Buenos Aires Mácula Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Unknown status |
| CICEMO- Consultorio de Investigación Clínica EMO Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Unknown status |
| Instituto Medico Especializado_Capital Federal Coordinator of this site? Confirm its status | Ciudad de Buenos Aires | Argentina | Unknown status |
| Instituto de Investigaciones Clinicas Mar del Plata Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| CEDIR - Centro de diagnóstico y rehabilitación Santa Fe Coordinator of this site? Confirm its status | Santa Fe | Argentina | Unknown status |
| Paratus Clinical Coordinator of this site? Confirm its status | Blacktown | 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 | Kanwal | Australia | Unknown status |
| Hunter Diabetes Centre Coordinator of this site? Confirm its status | Merewether | Australia | Unknown status |
| University of Sunshine Coast - Morayfield Coordinator of this site? Confirm its status | Morayfield | Australia | Unknown status |
| Southern Adelaide Diabetes & Endocrine Services Coordinator of this site? Confirm its status | Oaklands Park | Australia | Unknown status |
| The Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| The Royal Melbourne Hospital - Diabetes & Endocrinology Department Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Austrials Coordinator of this site? Confirm its status | St Albans | Australia | Unknown status |
| Momentum Clinical Research Sunshine Coordinator of this site? Confirm its status | St Albans | Australia | Unknown status |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
| Momentum Clinical Research Taringa Coordinator of this site? Confirm its status | Taringa | Australia | Unknown status |
| Centricity Research Oshawa Coordinator of this site? Confirm its status | Barrie | Canada | Unknown status |
| Centricity Research Brampton Endocrinology Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| Centricity Research Calgary Endocrinology Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Western Univ. Cnt for Studies in Fam Med Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Milestone Research Coordinator of this site? Confirm its status | London | 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 |
| Clinique des Maladies Lipidiques de Quebec Inc. Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Centre de Recherche Saint-Louis Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Clin des Mal Lipid de Quebec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Alpha Recherche Clinique 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 |
| Guilford Med Clinic Coordinator of this site? Confirm its status | Surrey | Canada | Unknown status |
| Ocean West Research Clinic Coordinator of this site? Confirm its status | Surrey | Canada | Unknown status |
| Hilltop Medical Clinic Coordinator of this site? Confirm its status | Surrey | Canada | Unknown status |
| TLC Diabetes and Endocrinology 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 |
| Centricity Research Toronto Coordinator of this site? Confirm its status | Toronto | 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 |
| Clinica De La Costa Coordinator of this site? Confirm its status | Barranquilla | Colombia | Unknown status |
| Cimedical Coordinator of this site? Confirm its status | Barranquilla | Colombia | Unknown status |
| UNIENDO Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Centro de Investigación en Reumatología y Especialidades Médicas S.A.S. CIREEM S.A.S. Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| FOSCAL Coordinator of this site? Confirm its status | Floridablanca | Colombia | Unknown status |
| Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University Coordinator of this site? Confirm its status | Aligarh | India | Unknown status |
| Belgaum Diabetes Centre Coordinator of this site? Confirm its status | Belagavi | India | Unknown status |
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| Diabetes, Thyroid and Endocrine Centre Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| BP Poddar Hospital Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Government Medical College, Kozhikode Coordinator of this site? Confirm its status | Kozhikode | India | Unknown status |
| Seth GS Medical College & KEM Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| BSES MG hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Government Institute of Medical Sciences Coordinator of this site? Confirm its status | Noida | India | Unknown status |
| Chellaram Diabetes Institute Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Grant Medical Foundation Ruby Hall Clinic Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Nirmal Hospital Pvt Ltd. Coordinator of this site? Confirm its status | Surat | India | Unknown status |
| Indian Institute of Diabetes Coordinator of this site? Confirm its status | Thiruvnanthapuram | India | Unknown status |
| Jothydev's Diabetes & Research Center Coordinator of this site? Confirm its status | Thriruvananthapuram | India | Unknown status |
| SSG Hospital, Baroda Coordinator of this site? Confirm its status | Vadodara | India | Unknown status |
| Christian Medical College Hospital, Vellore Coordinator of this site? Confirm its status | Vellore | India | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Chung Shan Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Kuang Tien General 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 |
| National Taiwan University Hospital_main Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
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| Remington Davis, Inc. Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
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| Cedar Health Research Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| North Texas Endocrine Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
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