Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a) (MOVE-Lp(a))

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Atherosclerotic Cardiovascular Disease (ASCVD); Elevated Lp(a)

Treatments: Drug: Placebo; Drug: Muvalaplin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07157774

2025-521067-13-00 (EU Trial (CTIS) Number)

27269

J2O-MC-EKBG (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.

Enrollment: 10,450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have Lp(a) ≥175 nanomoles per liter (nmol/L)

• Meet one of the following criteria:

  • Have had a prior atherosclerotic cardiovascular disease (ASCVD) event (such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body) within 10 years prior to screening

  • Are at risk for a first ASCVD event, defined as one or more of the following:

    • Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without a history of ASCVD event
    • A high coronary artery calcium (CAC) score
    • Reduced kidney function with diabetes
    • Combination(s) of high risk factors

Exclusion criteria

• Have experienced a major cardiovascular event or surgery, such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body, within 90 days prior to screening or occurring between screening and randomization
• Are planning or expected to undergo a procedure to restore blood flow in the arteries or a major heart surgery during the study
• Have uncontrolled high blood pressure
• Have New York Heart Association (NYHA) class III or IV heart failure
• Have undergone a procedure to remove cholesterol from the blood within 90 days of screening, or have a planned procedure during the study
• Have severe kidney impairment
• Have had cancer within 5 years prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10,450 participants in 2 patient groups, including a placebo group

Muvalaplin

Experimental group

Description:

Participants will receive muvalaplin orally.

Treatment:

Drug: Muvalaplin

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally.

Treatment:

Drug: Placebo