Lipoprotein(a), also known as Lp(a), is a protein that carries cholesterol and proteins in your blood. People with high Lp(a) have a higher risk for heart disease. The main purpose of the study is to investigate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the heart's vessels using an imaging technology known as Coronary Computed Tomography Angiography (CCTA) in adults who have high levels of Lp(a).
Participation will last about 120 weeks.
Have an Lp(a) ≥175 nmol/L
Have established cardiovascular (CV) disease or are at risk for a first CV event
Have angiographic evidence of coronary artery disease on screening CCTA
If taking lipid-lowering medications, inclusive of statins or prescription strength niacin and PCSK9 inhibitors, these should be stable for 8 weeks
Have had a major CV event less than 60 days before measurement of the Lp(a) level used for eligibility or uncontrolled high blood pressure at screening
Have moderate to severe renal dysfunction
Have severe heart failure
Have a history of coronary artery bypass graft surgery (CABG)
Parallel
Lepodisiran
DrugAdministered SC
Placebo
DrugAdministered SC
Percent Change from Baseline in Noncalcified Plaque (NCP) Volume
Percent Change from Baseline in Mean Fat Attenuation Index (FAI) Score
Percent Change from Baseline in Lp(a) Level
Percentage of Participants Reporting Strongly Agree or Agree on the Subcutaneous Administration Assessment Questionnaire (SQAAQ) Version 3.0 Items
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3819469
Click on the lead sponsor to view all of their trials.