Status:
COMPLETED
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. W...
Eligibility Criteria
Inclusion
- Male or female
- Age above or equal to 18 years at the time of signing informed consent
- BMI greather than or equal to 27.0 kg/m\^2
- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
- Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
- Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
- HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening
Exclusion
- Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
- Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2, as measured by the central laboratory at screening
- 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.
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2025
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT05394519
Start Date
February 1 2023
End Date
February 3 2025
Last Update
November 18 2025
Active Locations (179)
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1
John Muir Physicians Network
Concord, California, United States, 94520
2
Headlands Research California, LLC
Escondido, California, United States, 92025
3
Providence Medical Foundation
Fullerton, California, United States, 92835
4
St. Jos Heritage Hlthcr_Fllrtn
Fullerton, California, United States, 92835