obesitas en overgewicht Obesity overweight
Conditions
Interventions
Subjects are randomised (21:3:3:7) in the groups: subcutaneous injection of
cagrisema (cagrilintide/semaglutide) 2.4 mg/2.4 mg, cagrilintide 2.4 mg,
semaglutide 2.4 mg or placebo once weekly.
All pa
Sponsors
Novo Nordisk
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male or female - Age above or equal to 18 years at the time of signing informed consent - BMI greater than or equal to 30.0 kg/m^2 or b) 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 hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
Exclusion criteria
Exclusion criteria: Glycaemia related: -HbA1c greater than or equal to 6.5 % (48 mmol/mol) as measured by the central laboratory at screening -History of type 1 or type 2 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change in body weight From baseline (week 0) to end of treatment (week 68) % Achievement of >= 5% weight reduction From baseline (week 0) to end of treatment (week 68) | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement of >= 20% weight reduction From baseline (week 0) to end of treatment (week 68) To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on achievement of >= 25% weight reduction. Achievement of >= 25% weight reduction From baseline (week 0) to end of treatment (week 68) To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on achievement of >= 30% weight reduction. Achievement of >= 30% weight reduction From baseline (week 0) to end of treatment (week 68) To confirm superiority of CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg on body weight. To confirm superiority of CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg on body weight. Relative change in body weight From baseline (week 0) to end of treatment (week 68) % To confirm superiority of CagriSema 0.5 mg/0.5 mg versus placebo on body weight Relative change in body weight From baseline (week 0) to week 8 % To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on body weight Relative change in body weight From baseline (week 0) to week 20 % To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on: • Waist circumference • Systolic blood pressure • Physical functioning Change in waist circumference From baseline (week 0) to end of treatment (week 68) cm Change in systolic blood pressure (SBP) From baseline (week 0) to end of treatment (week 68) mmHg Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score From baseline (week 0) to end of treatment (week 68) Score points Change in Short Form-36 Version 2.0 (SF-36v2) Physical Functioning score From baseline (week 0) to end of treatment (week 68) Score points Secondary supportive safety endpoints To compare the safety and tolerability of CagriSema 2.4 mg/2.4 mg versus placebo, semaglutide 2.4 mg and cagrilintide 2.4 mg. Number of Treatment-emergent Adverse Events (TEAEs) From baseline (week 0) to end of studymain (week | — |
Countries
Netherlands
Outcome results
None listed