A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight (REDEFINE 6)
Obesity or Overweight
About this trial
This is an interventional treatment trial for Obesity or Overweight
Eligibility 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: 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
Sites / Locations
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational SiteRecruiting
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
CagriSema
Semaglutide
Placebo
Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.
Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.