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

JRCT ID: jRCT2031220671

Registered date:02/03/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: overweight or obesity and type 2 diabetes
• Date of first enrollment: 01/03/2023
• Target sample size: 45
• Countries of recruitment: Austria,Japan,Canada,Japan,Germany,Japan,Hungary,Japan,India,Japan,Ireland,Japan,Malaysia,Japan,Poland,Japan,Thailand,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): This is an interventional 68-week randomised, double-blind, placebo-controlled, two-arm, parallel group, multicentre, multinational clinical study comparing CagriSema s.c. 2.4 mg/2.4 mg once-weekly with placebo, both as an adjunct to a reduced-calorie diet and increased physical activity, in participants with overweight or obesity and type 2 diabetes (T2D).

Outcome(s)

Primary Outcome

Relative change in body weight
Achievement of over 5% weight reduction

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-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

Exclude criteria

-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

Related Information

• Primary Sponsor: Ishikawa Wataru
• Secondary ID(s): NCT05394519