Table 4: Phase III Clinical Trials in Subjects with Hypercholesterolaemia Treated with Monoclonal Antibodies.

Monoclonal Antibody	Name of Phase III	Population
Evolocumab	MENDEL-2 GAUSS-2 LAPLACE-2 FOURIER	Subjects with hypercholesterolaemia, Framingham Risk score < 10%, monotherapy Statin-intolerant subjects, compared to ezetimibe Subjects with hypercholesterolaemia, statin intolerance, ezetimibe controlled Subjects treated with evolocumab on high or low dose statin Evaluating cardiovascular outcomes in subjects with hypercholesterolaemia and elevated risk cardiovascular risk
Alirocumab	ODYSSEY COMBO-I CHOICE I CHOICE II LONG TERM OUTCOMES	Global Phase III program subjects treated with maximally tolerated statin therapy Alirocumab administered every four weeks compared with placebo Alirocumab as monotherapy compared to other non-statin lipid lowering therapies Alirocumab use in the background of lipid lowering therapies and long term safety and efficacy Alirocumab effects in cardiovascular outcomes in subjects with acute coronary syndrome
Bocolicumab	SPIRE-1 SPIRE-2 SPIRE-IS SPIRE-HR SPIRE-LL	CV outcomes in subjects with high risk and LDL-C ≤ 70 but ≤ 100 mg dL CV outcomes in subjects with high risk and LDL-C ≥ 100 mg dL Subjects who are intolerant to statin Subjects with high or very high risk for CV events Subjects with primary hyperlipidaemia at high or very high risk