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
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Atherosclerosis, Cardiovascular Diseases, Lipoprotein(a)
In brief
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.
Key facts
- Study ID
- NCT07613294
- Run by
- Eli Lilly and Company
- People needed
- 252
- Starts
- 2026-06-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinitrials — West Perth, Australia (enrolling)
- Carilion Clinic — Roanoke, Virginia, United States (enrolling)
- USC Clinical Trials Brisbane (South Bank) — South Brisbane, Australia (enrolling)
- Profound Research LLC — Farmington Hills, Michigan, United States (enrolling)
- University of the Sunshine Coast (UniSC) Clinical Trials - Birtinya — Birtinya, Australia (enrolling)
- Eastside Research Associates — Redmond, Washington, United States (enrolling)
- Clinical Site Partners, LLC dba Flourish Research — Winter Park, Florida, United States (enrolling)
- Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care — Fort Lauderdale, Florida, United States (enrolling)
- Vector Clinical Trials — Las Vegas, Nevada, United States (enrolling)
- AIM Research — Merewether, Australia (enrolling)
- Valley Clinical Trials, Inc. — Northridge, California, United States (enrolling)
- Merritt Island Medical Research, LLC — Merritt Island, Florida, United States (enrolling)
- Inpatient Research Clinic — Miami Lakes, Florida, United States (enrolling)
- Nightingale Research — Adelaide, Australia (enrolling)
- Virginia Heart — Falls Church, Virginia, United States
- Intermountain Medical Center — Murray, Utah, United States
- Advara HeartCare - Mulgrave — Mulgrave, Australia
- Heart and Vascular Research at WellSpan Health — York, Pennsylvania, United States
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
- Advara HeartCare Leabrook — Leabrook, Australia
- Advara HeartCare Joondalup — Joondalup, Australia
- Advara HeartCare - Burwood — Burwood, Australia
- Core Research Group — Brisbane, Australia
- Massachusetts General Hospital — Boston, Massachusetts, United States
- CARE Institute - High Desert — Meridian, Idaho, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.