Phase II Study of ABP-745 Tablets to Treat Atherosclerosis Cardiovascular Disease in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating the preliminary efficacy, safety, and population pharmacokinetics PopPK of ABP-745 in adults aged 18 to 75 years who have atherosclerotic cardiovascular disease ASCVD. This randomized, double-blind, placebo-controlled Phase II study aims to compare the ability of ABP-745 to reduce atherosclerotic plaque against a placebo. The primary measurement of efficacy will be the change in percent atheroma volume PAV after 52 weeks of treatment. Participants will be randomly assigned to one of four groups placebo or one of three different doses of ABP-745 tablets taken orally once daily. Throughout the study, existing lipid-lowering maintenance medications will remain unchanged. The study includes a 52-week treatment period, after which the primary outcome will be assessed. Safety and tolerability will also be monitored up to 14 days after the last dose. During the study, participants will continue their current oral lipid-lowering therapy and attend regular visits for assessments including physical exams, vital signs, laboratory tests, and ECGs. Researchers will measure changes in atherosclerotic plaque volume and monitor for adverse events. The total duration of participation includes the 52-week treatment period plus safety follow-up, with detailed monitoring to evaluate the impact and safety of ABP-745 in this population.

Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis