Monterey Park

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating a new care strategy for people at increased risk of atherosclerotic cardiovascular disease ASCVD but without symptoms. The study compares a Cleerly Coronary Artery Disease CAD Staging System-based care approach against the usual risk factor-based care to see if it better reduces cardiovascular events. This pragmatic, randomized trial addresses the need for improved methods to identify and personalize treatment for asymptomatic individuals at risk due to age, diabetes, prediabetes, or metabolic syndrome. Participants are randomly assigned to one of two groups. The risk factor-based care group receives usual care managed by their providers, while a cardiology team monitors and supports guideline-based treatment without revealing certain imaging results during the study. The Cleerly stage-based care group gets personalized management from a remote cardiologist-led team using the Cleerly CAD Staging System, which includes imaging to assess coronary atherosclerosis and guides pharmacotherapy and education. Treatment intensity may increase if plaque worsens after 24 months. During the study, participants will have assessments to monitor heart health and treatment adherence over an average of 3.5 years. Researchers will measure cardiovascular events and other related health outcomes to compare the two care strategies. The study involves ongoing medication monitoring, lab tests, and feedback to optimize prevention, with the goal of improving personalized care for cardiovascular risk management.

Researchers are studying the safety and tolerability of NTR-1011, a fusion protein designed to reduce inflammation by clearing neutrophil extracellular traps, in adults with systemic lupus erythematosus SLE and rheumatoid arthritis RA, as well as in healthy adult volunteers. This Phase 1ab clinical trial aims to determine the highest safe dose of NTR-1011 given either under the skin or intravenously, understand how the body processes the drug, assess immune response to it, and explore early signs of benefit when added to standard treatments. The study has two parts Phase 1a, completed with healthy volunteers receiving single doses of NTR-1011 or placebo via intravenous or subcutaneous routes and Phase 1b, currently recruiting adults with moderate-to-severe SLE or RA who receive five weekly intravenous doses of NTR-1011 alongside their usual care. Dose levels in Phase 1b are adjusted based on safety and response data. No placebo group exists in Phase 1b, and participants are assigned to either the SLE or RA group. Participants undergo physical exams, lab tests, vital sign monitoring, and blood sampling to measure drug levels, immune markers, and antibodies against NTR-1011. Clinical assessments include disease activity scores and patient-reported outcomes specific to SLE and RA. Safety and tolerability are closely monitored throughout treatment and for four weeks after the last dose. The studys findings will help guide future development and dosing of NTR-1011 for autoimmune diseases.