Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema)2.4 mg/2.4 mg s.c. once weekly versus tirzepatide 15 mg s.c. once weekly in participants with type2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor - REIMAGINE 4 (NN9388-4894)

ovo Nordisk0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

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•1. Male or female.
•2. Age 18 years or above at the time of signing the informed consent.
•3. Diagnosed with type 2 diabetes more than or equal to 180 days before screening.
•4. Stable daily dose(s) more 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 an SGLT2 inhibitor.
•5. HbA1c 7.0-10.5 percent (53-91 mmol per mol) (both inclusive) as determined by central laboratory at
•6. BMI more than or equal to 30 kg per m2 at screening. BMI will be calculated in the eCRF based on height and body
•weight at screening.

•1.Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing
•potential and not using a highly effective contraceptive method.
•2.Renal impairment with estimated Glomerular Filtration Rate more than 30 ml per min per 1.73 m2 as determined by central laboratory at screening.
•3.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.
•4. 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

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