Effect of Muvalaplin on Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) and Atherosclerotic Cardiovascular Disease: A Phase 3 Randomized Trial

The primary objective is to evaluate the superiority of muvalaplin compared to a placebo in reducing the risk of the composite endpoint MACE-4 in adults with elevated lipoprotein(a) who have a history of atherosclerotic cardiovascular disease or are at risk for a first event. This study assesses therapy, efficacy, pharmacokinetics, pharmacodynamics, safety, pharmacogenomics, and pharmacoeconomics.

This study involves a total of 7,290 patients. The study population includes both males and females within the age ranges corresponding to codes 3 and 4. Participants are characterized by elevated Lp(a) levels of 175 nmol/L or higher and a diagnosis of atherosclerotic cardiovascular disease. The selection process identifies individuals who have experienced a prior cardiovascular event, such as a myocardial infarction, stroke, or revascularization procedure. Additionally, the population includes those at risk for a primary event, defined by conditions including coronary artery disease, carotid stenosis, peripheral artery disease, a high coronary artery calcium score, or diabetic nephropathy.

This Phase 3, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy of muvalaplin in reducing the risk of the MACE-4 composite endpoint. The investigation focuses on adults with elevated Lipoprotein(a) who have a history of atherosclerotic cardiovascular disease or are at risk for a first cardiovascular event. Participants will be assigned to receive either muvalaplin administered via oral use as a tablet or a matching placebo. The primary objective is to determine if muvalaplin is superior to placebo in reducing the time to the first occurrence of any component within the composite endpoint. The study is expected to conclude by March 2031.

The experimental treatment consists of muvalaplin administered in a tablet pharmaceutical form. This substance is intended for oral use.

The control group receives a placebo designed to match the appearance of the active medication.

The efficacy of muvalaplin will be assessed by evaluating its ability to reduce the risk of a composite endpoint. The primary endpoint is defined as the time to first occurrence of any component of the major adverse cardiovascular events (MACE)-4 composite endpoint.