Recruiting

Phase 3

LepodisiranA 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

Sponsor:

Eli Lilly and Company

Code:

NCT07613294

Conditions

Atherosclerosis

Cardiovascular Diseases

Lipoprotein(a)

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Lepodisiran

Placebo

Study Details

Brief summary:

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

Atherosclerosis

Cardiovascular Diseases

Lipoprotein(a)

Study ID

NCT07613294

Start date

Jun 1, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

252 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lepodisiran

Participants will receive lepodisiran subcutaneously (SC)

placebo comparator: Placebo

Participants will receive placebo SC

Interventions

Lepodisiran

Administered SC

Placebo

Administered SC

Primary outcome measure

Percent Change from Baseline in Noncalcified Plaque (NCP) Volume [ Time Frame: Baseline, Week 104 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Valley Clinical Trials, Inc.

Recruiting

Northridge, California, United States, 91325

Contacts

818-678-4900

Principal Investigator:

Mehrdad Ariani

Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care

Recruiting

Fort Lauderdale, Florida, United States, 33312

Contacts

954-963-7100

Principal Investigator:

Sam Lerman

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

904-730-0101

Principal Investigator:

Erich Schramm

Merritt Island Medical Research, LLC

Recruiting

Merritt Island, Florida, United States, 32952

Principal Investigator:

David Kirk

Inpatient Research Clinic

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

786-502-4303

Principal Investigator:

Alexis Gutierrez

Clinical Site Partners, LLC dba Flourish Research

Recruiting

Winter Park, Florida, United States, 32789

Contacts

407-740-8078

Principal Investigator:

Monica Aggarwal

Profound Research LLC

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

947-254-1920

Principal Investigator:

Herman-Simon Kado

Vector Clinical Trials

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

702-750-000

Principal Investigator:

Bharat Mocherla

Heart and Vascular Research at WellSpan Health

Recruiting

York, Pennsylvania, United States, 17403

Contacts

717-851-2441

Principal Investigator:

Rhian Davies

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24014

Principal Investigator:

Lana Wahid

Eastside Research Associates

Recruiting

Redmond, Washington, United States, 98052

Contacts

425-869-6828

Principal Investigator:

Christopher Price

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

CCTA
Coronary plaque burden

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-21.