Evaluate whether muvalaplin is superior to placebo in reducing the risk of the composite endpoint of MACE-4, defined as ; CV death ; nonfatal myocardial infarction ; nonfatal ischemic stroke, and ; urgent coronary revascularization Evaluate whether muvalaplin is superior to placebo in lowering Lp(a) levels
Study J2O-MC-EKBG is a Phase 3, global, randomized, double-blind, placebo-controlled, parallel-group, event-driven study to investigate the reduction of MACE with muvalaplin treatment compared to placebo in adult participants with elevated Lp(a) and a prior ASCVD event or at risk for a first ASCVD event.
are individuals who are at least 18 years of age ; have an Lp(a) laboratory measurement that is m0ore or equal 175 nmol/L ; have had a prior ASCVD event or are at risk for a first ASCVD event, and ; are willing to make themselves available for the duration of the study, attend required study visits, and are willing and able to follow study procedures. Informed consent 1. Are capable of giving signed informed consent as described in Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Age 2. Participant must be at least 18 years of age, inclusive, or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent. Type of participant and disease characteristics 3. Have Lp(a);175 nmol/L at prescreening (Visit 601) or screening (Visit 1) as measured by the central laboratory. ; Only the first Lp(a) result assayed by the central laboratory (Visit 601 or Visit 1) is used to determine participant eligibility. 4. Have the disease characteristics of either 4a or 4b: 4a. Individuals with a prior ASCVD event, defined as having experienced at least 1 of the following listed in the table, with the most recent ASCVD event occurring between ;90 days and 10 years prior to screening (Visit 1).
Protocol Number: 26-0365
Principal Investigator