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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 45 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lepodisiran 		Participants will receive lepodisiran subcutaneously (SC)
  • Drug: Lepodisiran
    Administered SC
    Other names:
    • LY3819469
Placebo Comparator
Placebo 		Participants will receive placebo SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida 33312
Contact:
954-963-7100

Merritt Island Medical Research, LLC
Merritt Island, Florida 32952

Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida 32789
Contact:
407-740-8078

Profound Research LLC
Farmington Hills, Michigan 48334
Contact:
947-254-1920

Vector Clinical Trials
Las Vegas, Nevada 89128
Contact:
702-750-000

Eastside Research Associates
Redmond, Washington 98052
Contact:
425-869-6828

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.