About this trial
The primary objective of this trial is to evaluate the effect of olpasiran, compared to placebo, on non-calcified plaque (NCP) volume as measured by Coronary Computed Tomography Angiography (CCTA).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 35 to ≤ 80 years.
Lp(a) ≥ 200 nmol/L during screening.
Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA.
History of myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or coronary revascularization by percutaneous coronary intervention.
Disqualifiers
History of coronary artery bypass graft (CABG).
Moderate to 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.
Trial design
Parallel
Treatments tested in this trial
Olpasiran
DrugOlpasiran will be administered SC.
Placebo
DrugPlacebo will be administered SC.
Treatment groups
Trial outcomes
Primary outcomes
Change in NCP Volume from Baseline to Week 72
Secondary outcomes
Change in Low Attenuation Plaque Volume from Baseline to Week 72
Change in Total Plaque Volume from Baseline to Week 72
Change in Calcified Plaque Volume from Baseline to Week 72
Number of Participants with Treatment-emergent Adverse Events (TEAEs)