Recruiting

Phase 3

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

Sponsor:

Eli Lilly and Company

Code:

NCT07157774

Conditions

Elevated Lp(a)

Atherosclerotic Cardiovascular Disease (ASCVD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Muvalaplin

Placebo

Study Details

Brief summary:

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.

Conditions

Elevated Lp(a)

Atherosclerotic Cardiovascular Disease (ASCVD)

Study ID

NCT07157774

Start date

Sep 2, 2025

Status verified date

Sep, 2026

Completion date

Mar, 2031

Anticipated

Primary completion date

Mar, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Muvalaplin

Participants will receive muvalaplin orally.

placebo comparator: Placebo

Participants will receive placebo orally.

Interventions

Muvalaplin

Administered orally

Placebo

Administered orally

Primary outcome measure

Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint [ Time Frame: Baseline up to End of Study (About 5.25 Years) ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Care Access - Huntington Beach

Recruiting

Huntington Beach, California, United States, 92648

Contacts

714-378-2440

Principal Investigator:

Christine Thai

Care Access - Tamarac

Recruiting

Tamarac, Florida, United States, 33321

Contacts

877-791-0656

Principal Investigator:

Brad Lipson

Care Access - Tampa

Recruiting

Tampa, Florida, United States, 33625

Contacts

813-771-5980

Principal Investigator:

Shital Mehta

Care Access - Quincy

Recruiting

Quincy, Massachusetts, United States, 02169

Contacts

877-791-0656

Principal Investigator:

Chih Chao Yang

Care Access - Fayetteville

Recruiting

Fayetteville, North Carolina, United States, 28314

Contacts

910-249-9855

Principal Investigator:

Daniel Uba

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.