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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
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

NCT07613294

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Atherosclerosis, Cardiovascular Diseases, Lipoprotein(a)

Interventions: Lepodisiran, Placebo

Countries: United States, Australia, Czechia, Hungary, Netherlands, Spain, United Kingdom

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 overview

Sex: ALL

Age: 45 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Have a planned coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft, or valvular intervention
* Have had a procedure to remove lipoproteins from the blood or received therapy specifically targeting Lp(a)
* Are unable to safely undergo CCTA due to medication intolerance, contrast allergies, or anatomical/technical factors
Locations (58)
  • La Jolla, California, United States
  • Northridge, California, United States
  • Torrance, California, United States
  • Fort Lauderdale, Florida, United States
  • Jacksonville, Florida, United States
  • Merritt Island, Florida, United States
  • Miami Lakes, Florida, United States
  • Winter Park, Florida, United States
  • Meridian, Idaho, United States
  • Boston, Massachusetts, United States
  • Farmington Hills, Michigan, United States
  • Las Vegas, Nevada, United States
  • York, Pennsylvania, United States
  • Murray, Utah, United States
  • Falls Church, Virginia, United States
  • Roanoke, Virginia, United States
  • Redmond, Washington, United States
  • Adelaide, Australia
  • Birtinya, Australia
  • Brisbane, Australia
  • Burwood, Australia
  • Joondalup, Australia
  • Leabrook, Australia
  • Merewether, Australia
  • Mulgrave, Australia
  • South Brisbane, Australia
  • West Perth, Australia
  • Brno, Czechia
  • Brno, Czechia
  • Brno, Czechia
  • + 28 more on CT.gov