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)

JRCT ID: jRCT2031220734

Registered date:26/03/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 03/04/2023
• Target sample size: 320
• Countries of recruitment: Taiwan,Japan
• Study type: Interventional
• Intervention(s): 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

Outcome(s)

• Primary Outcome: 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

Key inclusion & exclusion criteria

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

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Sudo Yuki