Long-term efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema 2.4 mg/2.4 mg) once weekly versus placebo in participants with obesity

简要总结

主要结局

次要结局

• Achievement of ≥ 20% body weight reduction (yes/no)
• Achievement of ≥ 25% body weight reduction (yes/no)
• Achievement of ≥ 30% body weight reduction (yes/no)
• Change in waist circumference
• Change in waist to height ratio
• Change in SBP
• Ratio to baseline in: • Total cholesterol • High density lipoprotein (HDL) cholesterol • Low density lipoprotein (LDL) cholesterol • Very low-density lipoprotein (VLDL) cholesterol • Triglycerides • Free fatty acids • Non-HDL cholesterol
• Change in BMI
• Achievement of BMI < 30 kg/m2
• Change in glycated haemoglobin (HbA1c)
• Change in Fasting Plasma Glucose (FPG)
• Achievement of HbA1c < 5.7% and FPG < 100 mg/dL with prediabetes at baseline
• Time to HbA1c < 5.7% and FPG < 100 mg/dL with prediabetes at baseline
• Development of HbA1c ≥ 5.7% or FPG > 100 mg/dL with normoglycemia at baseline
• Development of T2D as per ADA guideline
• Time to T2D diagnosis as per ADA guideline
• Change in ACC/AHA 10-year ASCVD risk score
• Improvement in ≥ 1 pre existing cardiometabolic ORC (hypertension, prediabetes, or dyslipidaemia)
• Ratio to baseline in C-reactive protein (CRP)
• Change in total fat mass by dual energy X-ray absorption (DXA) absolute and relative to total body mass
• Change in visceral fat mass by DXA, relative to baseline and relative to total amount of fat mass in visceral fat mass region
• Change in lean body mass by DXA absolute and relative to total body mass
• Change in SF-36 Physical functioning score
• Change in IWQOL-Lite-CT: • Physical function score • Physical score • Psychosocial score • Total score
• Change in Impact of Weight on Daily Activities Questionnaire (IWDAQ) Composite score
• Change in Control of Eating questionnaire (CoEQ): • Craving Control score • Positive Mood score • Craving for Sweets score • Craving for Savoury score • Hunger score • Satiety score
• Number of Treatment Emergent Adverse Events (TEAEs)
• Number of Treatment Emergent Serious Adverse Events (TESAEs)
• Achievement of HbA1c ≥ 6.5% or FPG ≥ 126 mg/dL with prediabetes at baseline
• Time to HbA1c ≥ 6.5% or FPG ≥ 126 mg/dL with prediabetes at baseline