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

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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