Morganton

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms: the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are evaluating maridebart cafraglutide in adults aged 45 to 99 years who have atherosclerotic cardiovascular disease and are overweight or obese. The study aims to determine if maridebart cafraglutide, when added to standard care, is better than a placebo in reducing serious heart-related problems and deaths. This is a Phase 3 randomized, double-blind, placebo-controlled trial sponsored by Amgen. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given as subcutaneous injections. The study treatment is given alongside their usual care. The trial will last for approximately 35 months, during which time researchers will monitor cardiovascular events such as heart attacks, strokes, and deaths, as well as other health measures. During the study, participants will have regular visits for monitoring safety and health status. Researchers will assess heart-related events, blood pressure, body measurements, blood markers such as cholesterol and blood sugar levels, and kidney function. The main outcomes include time to first major cardiovascular event and changes in various health indicators over about three years. Safety monitoring will continue throughout the trial period.

Researchers are evaluating the safety and effectiveness of the dNerva Lung Denervation System as a one-time treatment to improve breathing in adults with Chronic Obstructive Pulmonary Disease (COPD). The study compares adding this new device treatment to standard COPD medical care versus standard care alone in patients who have high residual lung volume and low emphysema. The goal is to see if lung function improves and to confirm the safety of the lung denervation procedure. Participants are randomly assigned to one of two groups: one group receives the Targeted Lung Denervation (TLD) therapy using the dNerva system along with their usual COPD medications, and the other group continues with their standard medical care without additional intervention. The TLD therapy is a minimally invasive bronchoscopic treatment done once. Those in the control group who complete one year of follow-up may opt to receive the TLD treatment afterward and will be monitored for an additional year. During the study, participants will undergo various tests and assessments including lung function measurements like FEV1 at 6 and 12 months, lung volume changes, breathing difficulty scores, quality of life questionnaires, and tracking of COPD flare-ups over a year. Safety will be closely monitored throughout. The study lasts at least one year for primary follow-up, with some participants followed longer if they crossover to receive the treatment after one year.