Hopewell

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.

This research aims to evaluate the long-term safety and tolerability of pelacarsen TQJ230 administered once a month at 80 mg in patients who have elevated lipoproteina and established atherosclerotic cardiovascular disease ASCVD. The study is an open-label, rollover extension designed for participants who have successfully completed prior double-blind parent studies involving pelacarsen. Participants will receive open-label pelacarsen 80 mg by subcutaneous injection once every month during this extension program. This phase 3 study continues treatment from the parent trial and provides post-trial access to pelacarsen for eligible participants who completed their assigned treatments previously. During the study, participants will be monitored for adverse events and serious adverse events for up to 48 months. Researchers will also assess changes in lipoproteina levels compared to baselines from both the parent and extension studies at multiple time points, including baseline, 3, 12, 24, 36, and 48 months. Participants are expected to attend scheduled visits for safety evaluations and lab tests throughout the study duration.