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Found 2 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating the efficacy, safety, and tolerability of lunsekimig compared with a placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3 study focuses on patients with COPD who have specific lung function criteria, prior exacerbations, and blood eosinophil counts, aiming to better manage their condition using a new subcutaneous treatment. Eligible participants will receive subcutaneous injections of either lunsekimig or a matching placebo during a randomized intervention period lasting approximately 48 weeks. The study includes a screening period of up to 4 weeks before treatment and a follow-up period of about 8 weeks after treatment, making the total study duration up to 60 weeks. Participants remain in one of three study arms throughout this timeline. During the study, participants will be monitored regularly to measure the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will assess safety, tolerability, lung function, and other health outcomes. The study collects data on participants' lung function, exacerbation frequency, and blood markers, along with adherence to treatment and safety follow-up over the entire study period.