Munroe Falls

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 the effect of ION775 on fasting triglyceride levels in adults with hypertriglyceridemia and severe hypertriglyceridemia. This phase 2, open-label study aims to assess the safety, tolerability, and efficacy of ION775 in reducing triglyceride levels in these participants. The study is sponsored by Ionis Pharmaceuticals, Inc. Participants will be randomly assigned to one of three groups receiving ION775 by subcutaneous injection. The study includes a 4 to 6 week screening period, followed by a 6-month treatment period where participants receive ION775, and then a 6-month post-treatment follow-up period to monitor outcomes and safety. The study measures changes in fasting triglycerides and other cholesterol-related markers. During the study, participants will have assessments at baseline and at month 6 to measure triglyceride levels and other cholesterol components such as apolipoprotein C-III, very low-density lipoprotein cholesterol, remnant cholesterol, and non-high-density lipoprotein cholesterol. Safety is monitored through treatment-emergent adverse events and laboratory evaluations up to 12 months. Participants are involved in regular visits during the treatment and follow-up periods to evaluate the effects and safety of ION775.

Researchers are evaluating the effects of obicetrapib 10 mg, alone and combined with ezetimibe 10 mg, alongside standard lipid-lowering treatment in adults with metabolic syndrome andor Type 2 Diabetes Mellitus. This Phase 3, randomized, placebo-controlled, double-blind study aims to assess how these treatments affect cholesterol levels and their safety and tolerability. Participants will be assigned to one of three groups a fixed-dose combination daily of obicetrapib 10 mg plus ezetimibe 10 mg, obicetrapib 10 mg alone daily, or a placebo with standard lipid-lowering therapy. After the initial treatment period, there is an open-label extension where all may receive the combination of obicetrapib and ezetimibe. The study treatments are taken daily. During the study, participants will have their cholesterol and lipid levels measured at the start and after 84 days to evaluate changes in LDL-C and other lipid markers. The research team will monitor safety, tolerability, and other blood markers related to cholesterol. The entire study period includes initial treatment and an extension phase, with ongoing evaluations to understand how the treatments influence lipid levels and patient health.