Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
252 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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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 a…
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
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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