NewAmsterdam Pharma Company N.V. announced that it has met the enrollment target of 9,000 patients for the pivotal Phase 3 PREVAIL cardiovascular outcomes trial (?CVOT?) evaluating obicetrapib in adult patients with a history of atherosclerotic cardiovascular disease (?ASCVD?), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. Driven by strong patient and physician interest globally, NewAmsterdam will extend enrollment to the end of April where it expect to randomize over 9,000 patients. The double-blind, placebo-controlled Phase 3 PREVAIL trial is now expected to randomize over 9,000 patients with ASCVD in over 500 sites across 23 countries including the United States, Canada, United Kingdom, Netherlands, Germany, Japan, China, Italy, and Australia.

Patients enrolling in the study were required to have established ASCVD with LDL-C levels greater than 55 mg/dl, and an additional risk enhancer in participants with an LDL-C level below 100 mg/dl, despite taking maximally tolerated lipid-lowering therapy. Patients were randomized to receive placebo or 10 mg obicetrapib over a 30-month period. The primary objective of the study is to evaluate the effect of obicetrapib compared to placebo on MACE, including cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization.

Secondary objectives include evaluating the effect of obicetrapib on all-cause mortality, total CV events, new-onset diabetes mellitus, and change in LDL-C, non-high-density lipoprotein cholesterol, and apolipoprotein B levels.