Status:
COMPLETED
A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Obesity or Overweight
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 eithe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05996848
Start Date
August 15 2023
End Date
February 22 2025
Last Update
January 9 2026
Active Locations (37)
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1
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing Municipality, China, 100853
2
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China, 404000
3
Fujian Medical University Union Hospital-Endocrinology
Fuzhou, Fujian, China, 350001
4
Huizhou Central People's Hospital-Endocrinology
Huizhou, Guangdong, China, 516001