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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

NCT06534411

CompletedPhase 3

Sponsor: Novo Nordisk A/S

Conditions: Diabetes Mellitus, Type 2

Interventions: Cagrilintide, Semaglutide, Tirzepatide

Countries: United States, Argentina, Australia, Brazil, Canada, Germany, Greece, Hungary

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (163)

Pelham, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Chula Vista, California, United States
Concord, California, United States
La Mesa, California, United States
Los Angeles, California, United States
Palm Springs, California, United States
Santa Ana, California, United States
Van Nuys, California, United States
Colorado Springs, Colorado, United States
Washington D.C., District of Columbia, United States
Clearwater, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miramar, Florida, United States
Ocoee, Florida, United States
Orange City, Florida, United States
Pembroke Pines, Florida, United States
Fayetteville, Georgia, United States
Gurnee, Illinois, United States
West Des Moines, Iowa, United States
Topeka, Kansas, United States
Richfield, Minnesota, United States
Gulfport, Mississippi, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
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