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Assessing the Impact of Muval...

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

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

10450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-02

Study Completion Date

2031-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Elevated Lp(a) Atherosclerotic Cardiovascular Disease (ASCVD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Muvalaplin

Participants will receive muvalaplin orally.

Group Type EXPERIMENTAL

Muvalaplin

Intervention Type DRUG

Administered orally

Placebo

Participants will receive placebo orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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Muvalaplin

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY3473329

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Reach out to these primary contacts for questions about participation or study logistics.

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

Role: CONTACT

[email protected]

1-317-615-4559

Physicians interested in becoming principal investigators please contact

Role: CONTACT

[email protected]

Facility Contacts

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Other Identifiers

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2025-521067-13-00

Identifier Type: CTIS

Identifier Source: secondary_id

J2O-MC-EKBG

Identifier Type: OTHER

Identifier Source: secondary_id

27269

Identifier Type: -

Identifier Source: org_study_id

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Study Results

Basic Information

Brief Summary

Related Clinical Trials

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A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)

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Detailed Description

Conditions

Study Design

Study Groups

Muvalaplin

Muvalaplin

Placebo

Placebo

Interventions

Muvalaplin

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Eli Lilly and Company

Responsible Party

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Locations

CEINV Salud

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UBAM Unidad Biomedica Avanzada Monterrey

Clínica García Flores SC

Centro de investigación y control metabólico

Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC

Centro de Atención e Investigación Cardiovascular del Potosí

Axsendo Clinical Research - Peak Heart & Vascular - Phoenix

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