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REIMAGINE 5: A research study to see how much CagriSema (1.0 mg once weekly) lowers blood sugar and body weight compared to tirzepatide (5 mg once weekly) in people with type 2 diabetes treated with metformin, SGLT2 inhibitor or both
EU CTIS ID: 2023-509600-15-00
What this study is testing
To confirm non-inferiority on change in HbA1c and/or superiority on change in body weight of CagriSema 00 mg/00 mg versus tirzepatide 5 mg in participants with T2D in inadequate glycaemic control on stable dose of metformin, SGLT2i or both
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female.
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
- BMI ≥ 30 kg/m2 at screening. BMI will be calculated in the eCRF based on height and body weight at 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 - SGLT2 inhibitor
You likely can't join 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 < 30 ml/min/1.73 m2 as determined by central laboratory at screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- Israel
- Argentina
- Australia
- India
- Brazil
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; Israel; Argentina; Australia; India and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.