Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or obesity and type 2 diabetes
- Conditions
- overweight or obesity and type 2 diabetes
- Registration Number
- JPRN-jRCT2031220671
- Lead Sponsor
- Ishikawa Wataru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
Age above or equal to 18 years at the time of signing informed consent
-BMI greather than or equal to 27.0 kg/m2
-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, alpha-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
-Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
- Renal impairment with estimated glomerular filtration rate (eGFR)< 30 mL/min/1.73 m2, 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relative change in body weight<br>Achievement of over 5% weight reduction
- Secondary Outcome Measures
Name Time Method