A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age45-80
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Lepodisiran
  • Placebo

Treatment groups

252 Participants
are divided into 2 treatment groups

Sponsors and collaborators