Munroe Falls

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are investigating the effects of obicetrapib 10 mg, both combined with ezetimibe 10 mg as a fixed-dose combination and as monotherapy, in people with metabolic syndrome and/or Type 2 Diabetes Mellitus who are already receiving standard lipid-lowering therapy. This Phase 3, placebo-controlled, double-blind, randomized study aims to evaluate how well these treatments lower LDL cholesterol and assess their safety and tolerability. Participants will be assigned to one of three groups: obicetrapib 10 mg plus ezetimibe 10 mg fixed-dose combination, obicetrapib 10 mg alone, or placebo, all added to their existing guideline-recommended lipid-lowering therapy. The treatments are taken daily, and the study measures the percent change in LDL cholesterol from the start to Day 84. During the study, participants will undergo regular monitoring including lipid measurements and safety assessments. Researchers will carefully track changes in LDL cholesterol and other health markers over the 84-day treatment period. The study focuses on how these treatments perform in real-world patients with metabolic syndrome or Type 2 Diabetes while continuing standard care.