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 (ACCLAIM-CTA)

Lilly

Status and phase: Not yet enrolling; Phase 3

Conditions: Cardiovascular Diseases; Lipoprotein(a); Atherosclerosis

Treatments: Drug: Lepodisiran; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07613294

2025-524858-34-00 (EU Trial (CTIS) Number)

27554

J3L-MC-EZEJ (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 252 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 2 patient groups, including a placebo group

Lepodisiran

Experimental group

Description:

Participants will receive lepodisiran subcutaneously (SC)

Treatment:

Drug: Lepodisiran

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC

Treatment:

Drug: Placebo