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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) (REDEFINE 5)

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) (REDEFINE 5)

Sudo Yuki

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

JPHC_clinical_trials@novonordisk.com

Sudo Yuki

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

+81-362661000

JPHC_clinical_trials@novonordisk.com

Complete

April. 03, 2023

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

-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

Both

Obesity

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

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

+81-42-648-5551

Dec. 16, 2022

Yes

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Taiwan