Table 3.

Trials concerning PCSK-9 inhibition

Clinical trial	Mechanism of action	Molecules	Population	Phase	Endpoint	Expected/known results
ODYSSEY OUTCOME [19]	PCSK-9 antibodies	Alirocumab	18,000 post ACS patients	3	Combined CAD death/nonfatal acute MI	2017/2018
FOURIER [20]	PCSK-9 antibodies	Evolocumab	27,564 high risk patients with LDL-C > 1.8 mmol/L	3	Combined CAD, death/nonfatal acute MI	Early 2017
SPIRE 1 + 2 [21]	PCSK-9 antibodies	Bococizumab	28,000 patients on high residual risk	3	Combined death, MI, UAP, revascularization, stroke	Terminated due to the emerging clinical profile
ORION [34]	siRNA against PCSK-9	Inclisiran	480 patients with ASCVD or ASCVD-risk equivalents	2	Change in LDL-C from baseline to Day 180	−51%

CAD coronary artery disease, MI myocardial infarction, CV cardiovascular risk, LDL-C low-density lipoprotein cholesterol, UAP unstable angina pectoris, ACS acute coronary syndrome, ASCVD atherosclerotic cardiovascular disease, PCSK-9 proprotein convertase subtilisin/kexin type-9, siRNA small interfering RNA, ODYSSEY Safety and Tolerability of Alirocumab in High Cardiovascular Risk Patients with Hypercholesterolemia Not Adequately Controlled with Their Lipid Modifying Therapy, FOURIER Further cardiovascular OUtcomes Research with PCSK9 Inhibition in subjects with Elevated Risk, SPIRE Studies of PCSK9 Inhibition and the Reduction of vascular Events, ORION Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low-density Lipoprotein Cholesterol