Status:
ACTIVE_NOT_RECRUITING
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. Cagr...
Eligibility Criteria
Inclusion
- 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) greater than or equal to 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 Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors.
- Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
- Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( 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
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m\^2) as determined by central laboratory at screening.
- 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.
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2026
Estimated Enrollment :
2734 Patients enrolled
Trial Details
Trial ID
NCT06065540
Start Date
September 27 2023
End Date
January 5 2026
Last Update
December 23 2025
Active Locations (405)
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1
Synexus Clin Res-Birmingham
Birmingham, Alabama, United States, 35211
2
Univ of Alabama_Birmingham
Birmingham, Alabama, United States, 35294
3
Cahaba Research
Pelham, Alabama, United States, 35124
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Velocity Clinical Research-Phoenix
Phoenix, Arizona, United States, 85006