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
Completed · Phase 3
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT06534411
- Run by
- Novo Nordisk A/S
- People needed
- 1023
- Starts
- 2024-11-05
- Expected to finish
- 2026-07-09
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- 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.
- 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.
Where it is running
- 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
- 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
- Center for Diab,Obes & Metab — Pembroke Pines, 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
- Cahaba Research — Pelham, Alabama, United States
Full record on ClinicalTrials.gov
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