Obesity
Conditions
Interventions
CagriSema s.c.2.4 mg/2.4mg or semaglutide s.c.2.4 mg, both administered once-weekly, as an adjunct to a reduced-calorie diet and increased physical activity, in participants with overweight or obesity
Sponsors
Sudo Yuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan, Taiwan
Contacts
Public ContactYuki Sudo
Novo Nordisk Pharma Ltd.
Outcome results
None listed