A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight
About the study
This study will look at how well the new medicine CagriSema helps people with excess body weight losing weight compared to a "dummy" medicine and a medicine called semaglutide. Participants will either get CagriSema, a dummy medicine or semaglutide. Which treatment participants get is decided by chance. Participants will take one injection once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1 year.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Male or female
- Age above or equal to 18 years at the time of signing informed consent
- Body Mass Index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m^2) or
- BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one weight-related comorbidity including, but not limited to, type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
For participants with Type 2 diabetes (T2D) at screening the following criteria also apply:
- Diagnosed with type 2 diabetes mellitus greater than equal to 180 days before screening
- Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i)), thiazolidinediones, or sulphonylureas (SUs) 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 60 days before screening
- Glycated Haemoglobin (HbA1c) 7 percent-10 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by the central laboratory at screening
EXCLUSION CRITERIA
Exclusion Criteria:
For participants without T2D at screening:
- HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
- History of type 1 or type 2 diabetes mellitus
For participants with T2D at screening:
- Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
- Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m^2), 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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Obesity or Overweight
Age
18+
Phase
PHASE3
Participants Needed
300
Est. Completion Date
Apr 8, 2025
Treatment Type
INTERVENTIONAL
Sponsor
Novo Nordisk A/S
ClinicalTrials.gov NCT Identifier
NCT05996848
Study Number
NN9838-4827
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