Table 2 Primary and key secondary endpoints
Primary endpoint |
 Change (%) in non-HDL-C from baseline to week 24 in ITT population |
Key secondary efficacy endpoints |
 Change (%) from baseline in ITT population |
  Measured LDL-C at week 24 |
  Non-HDL-C at week 12 |
  Measured LDL-C at week 12 |
  Apo B at week 24 |
  TC at week 24 |
  Lp(a) at week 24 |
  TGs at week 24 |
  HDL-C at week 24 |
  LDL-P number at week 24 |
Other efficacy endpoints |
 Change (%) from baseline in ITT population |
  Calculated LDL-C at weeks 12 and 24 |
  Apo B, TC, Lp(a), HDL-C, TG, and LDL particle number at week 12 |
  Apo A-1, Apo C-III, TRL, LDL-P size, VLDL, HDL and IDL particle number at weeks 12 and 24 |
  Measured LDL-C and TG according to baseline TG (<median or >median) at weeks 12 and 24 |
 Patients (%) reaching |
  Measured LDL-C <50, 70 and 100 mg/dl at weeks 12 and 24 |
  Non-HDL-C <80, 100 and 130 mg/dl at weeks 12 and 24 |
  ≥50% reduction from baseline in measured LDL-C at weeks 12 and 24 |
  Apo B <80 mg/dl at weeks 12 and 24 |
 Absolute change from baseline in Apo B/Apo A-1, TC/HDL-C and LDL-C/HDL-C ratios at weeks 12 and 24 |
Diabetes-related endpoints |
 Absolute change from baseline to weeks 12 and 24 in ITT population |
  HbA1c |
  FPG |
  Number of glucose-lowering agents |
Safety endpoints |
 TEAEs |
 AESIs |
 Product complaints |
 Laboratory data (including microalbuminuria) |
 Vital signs (including change in body weight and BMI) |
Questionnaire |
 Treatment acceptance (I-TAQ) at weeks 8 and 24 (for alirocumab arm onlya) |
Other endpoints |
 Total and free PCSK9 levels at baseline, weeks 12 and 24 |
 Anti-alirocumab antibodies |