A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein[a] (NCT05581303)

The primary objective of this study is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

A/Prof James Shaw

Key inclusion data

Inclusion Criteria: Age 18 to ? 85 years; Lp(a)? 200 nmol/L during screening; History of ASCVD as evidenced by history of either Myocardial infarction and/or Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor. Exclusion Criteria: Severe renal dysfunction; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening; History of hemorrhagic stroke; History of major bleeding disorder; Planned cardiac surgery or arterial revascularization; Severe heart failure; Current, recent, or planned lipoprotein apheresis; Previously received ribonucleic acid therapy specifically targeting Lp(a).