See if Lepodisiran lowers coronary plaque in people with high Lp(a) and heart disease risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 3 trial, adults with elevated Lp(a) and cardiovascular risk or disease will be randomized to receive lepodisiran or placebo. The impact on coronary plaque is measured using coronary CT angiography (CCTA) over about 120 weeks. Recruitment requires stable lipid-lowering therapy and evidence of coronary artery disease on screening imaging. Primary outcomes focus on changes in plaque characteristics and burden. The study is sponsored by Eli Lilly and conducted at multiple California sites.

Why it matters

Who can join: the full rules

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

Where it's running

• UCSD - Altman Clinical and Translational Research Institute (ACTRI)
  La Jolla, California, United States Recruiting
• Valley Clinical Trials, Inc.
  Northridge, California, United States Recruiting
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  Torrance, California, United States Recruiting
• Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
  Fort Lauderdale, Florida, United States Recruiting
• Jacksonville Center for Clinical Research
  Jacksonville, Florida, United States Recruiting
• Merritt Island Medical Research, LLC
  Merritt Island, Florida, United States Recruiting

+7 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Colchicine for preventing cardiovascular disease in adults with type 2 diabetes

  A 24-week study will test whether low-dose colchicine can help protect blood vessels in adults with type 2 diabetes who have not yet developed artery disease, compared with a placebo.

  Recruiting Phase 2 Tan Tock Seng Hospital · Singapore, Singapore · NCT07837934

• Moderate-Intensity Statin + Ezetimibe vs High-Intensity Statin in CKD with ASCVD

  In adults with chronic kidney disease and established cardiovascular disease, this study tests whether a moderate-intensity statin plus ezetimibe can match the benefits of a high-intensity statin alone over three years.

  Recruiting Yonsei University · Seoul · NCT07524101

• Single versus dual antiplatelet therapy after drug-coated balloon angioplasty in elderly or high-bleeding-risk patients

  This study tests whether taking one antiplatelet medicine is as safe and causes less bleeding than taking two medicines for people aged 75 or older, or adults at high bleeding risk, after drug-coated balloon angioplasty for coronary artery disease.

  Recruiting Fondazione Ricerca e Innovazione Cardiovascolare ETS · Milan, MI · NCT06535568

• Investigating heart-related side effects of cancer immunotherapy

  This study is testing whether cancer immunotherapy treatments can cause heart problems in patients with certain types of cancer.

  Recruiting Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam, North Holland · NCT06519292

• Cardiovascular risk assessment for patients with lipid disorders in emergency care

  This study is testing a new way to help emergency room patients with high cholesterol lower their heart disease risk by providing better care compared to the usual treatment.

  Recruiting Phase 2 Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT06488105

• Comparing morning versus bedtime aspirin for cardiovascular health

  This study is testing if taking aspirin at bedtime works better than taking it in the morning for people who are already using aspirin to protect their heart health.

  Recruiting Phase 4 Herlev and Gentofte Hospital · Hellerup · NCT05932472

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.