Saratoga Springs

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 effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are studying the effects of the Alliance180 Program on the physical and psychological well-being of adults who are or were US Veterans, First Responders, and Front Line Healthcare Workers. The study focuses on how this program impacts feelings of safety, mental health issues like depression and anxiety, trauma response, and autonomic functioning. The investigation aims to understand these effects before and after the intervention to support this group experiencing trauma-related symptoms. Participants will take part in the 3-day Alliance180 Program, which includes a transformative equine experience designed to promote feelings of safety and trust. All participants follow the same study protocol without comparison groups. The program is delivered remotely with all data collected through online surveys before the program starts and then again at 1 week, 1 month, 3 months, and 6 months after completion. During the study, participants complete self-report questionnaires assessing trauma symptoms, anxiety, depression, perception of safety, body awareness, and purpose in life. These assessments occur at baseline and at various follow-up times to track changes over time. The main outcomes focus on changes in anxiety and depression scores at one month, with additional measures monitored up to six months after the program. The entire participation period spans about half a year following the initial program.

This research aims to evaluate the effects of supplementation with a synbiotic Plexus Triplex, a commercially available probiotic, or a placebo over 30 days on the gut microbiome, cardiometabolic health, body weight, and body composition in healthy adults aged 18 to 60 years. The study explores changes in gut bacterial counts, microbial diversity, short chain fatty acids, inflammatory markers, and mucosal immunity, as well as cardiovascular parameters and mood states. Participants will be randomly assigned to one of three groups synbiotic, probiotic, or placebo. The synbiotic group receives probiotic capsules, micronutrient capsules, and a prebiotic drink mix twice daily. The probiotic group takes probiotic capsules, collagen capsules, and placebo drink mixes twice daily. The placebo group receives collagen capsules and placebo drinks daily. This double-blind trial includes a 30-day supplementation period. During the study, participants will undergo assessments at baseline, 15 days, and 30 days, including gut microbiome analysis through 16s rRNA sequencing, blood pressure, vascular stiffness, heart rate variability, body composition, blood lipids, salivary inflammation, dietary analysis, and questionnaires on gastrointestinal health, fullness, hunger, and mood. The study monitors these measures to assess the effects of the supplements on gut and cardiometabolic health.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.

Researchers are evaluating olpasiran, compared to a placebo, to see how it affects the risk of coronary heart disease death, heart attacks, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have high levels of lipoproteina. This Phase 3 study focuses on participants aged 50 to 105 years with multiple cardiovascular risk factors or evidence of atherosclerosis. Participants will be randomly assigned to receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind, so neither participants nor researchers know who receives the active drug or placebo. Treatments and evaluations will continue for up to approximately 6.2 years. Throughout the study, participants will be monitored for heart-related events such as heart attacks, cardiovascular death, strokes, and coronary revascularizations. Researchers will also measure changes in lipoproteina levels at baseline and at Week 48, along with tracking adverse events. The total participation duration can extend up to about 6.2 years, with ongoing assessments to evaluate the treatments effect over time.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.