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 East Asian participants with overweight or obesity(NN9838-4762)
- Conditions
- Obesity
- Registration Number
- JPRN-jRCT2031220734
- Lead Sponsor
- Sudo Yuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 320
Male or female
-Age >=18 years at the time of signing informed consent
a) BMI >=27.0 kg/m2 with >=2 obesity-related complications or
b) BMI >=35.0 kg/m2 with >=1 obesity-related complication. At least one complication should be hypertension, dyslipidaemia or T2D.
Diabetes-related for participant with T2D
-Diagnosed with T2D >= 180 days before screening
-HbA1c 7.0-10.0%(53-86 mmol/mol))(both inclusive) as measured by central laboratory at screening
-Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, alfa-glucosidase inhibitors [AGI], glinides, sodium-glucose co-transporter 2 inhibitor [SGLT2i]), thiazolidinediones, or sulphonylureas [SU] 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.
Obesity-related
-Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
Glycaemia-related for participant without T2D
-HbA1c >=6.5% (48 mmol/mol) as measured by the central laboratory at screening
-History of type 1 or type 2 diabetes
Diabetes-related for participant with T2D
-Renal impairment with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as measured by central laboratory at screening
-Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness
-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 To confirm superiority on body weight reduction of CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg as adjuncts to a reduced-calorie diet and increased physical activity in East Asian participants with obesity or overweight
- Secondary Outcome Measures
Name Time Method