Recruiting NCT07157774

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

Phase III Interventional Elevated Lp(a) Atherosclerotic Cardiovascular Disease (ASCVD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Muvalaplin, Placebo.
Who it may be relevant to: Registry conditions: Elevated Lp(a), Atherosclerotic Cardiovascular Disease (ASCVD). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +23
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Had a Prior Atherosclerotic Cardiovascular Event or Are at Risk for a First Atherosclerotic Cardiovascular Event

Overview

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.

Interventions

Drug Muvalaplin
Administered orally
Drug Placebo
Administered orally

Primary outcome measures

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)]

Secondary outcome measures (9)

Percent Change from Baseline in Lipoprotein(a) (Lp(a)) at Week 4 [Time frame: Baseline, Week 4]
Time to First Occurrence of Any Component of the MACE-3 Composite Endpoint [Time frame: Baseline up to End of Study (About 5.25 Years)]
Time to First Occurrence of Any Component of the Modified MACE-3 Composite Endpoint [Time frame: Baseline up to End of Study (About 5.25 Years)]
Time to First Occurrence of Any Component of the Coronary MACE-3 Composite Endpoint [Time frame: Baseline up to End of Study (About 5.25 Years)]
Time to First Occurrence of Any Component of MACE-3 + Major Adverse Limb Event (MALE) Composite Endpoint [Time frame: Baseline up to End of Study (About 5.25 Years)]
Time to Occurrence of All-Cause Mortality [Time frame: Baseline up to End of Study (About 5.25 Years)]
Time to First Occurrence of Each Individual Component of the MACE-4 Composite Endpoint [Time frame: Baseline up to End of Study (About 5.25 Years)]
Change from Baseline to Each Annual Visit for Health-Care Resource Utilization (HCRU) [Time frame: Baseline up to End of Study (About 5.25 Years)]
Pharmacokinetics (PK): Trough Concentration at Steady State (C-trough, ss) of Muvalaplin [Time frame: Predose through Week 96]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment