Zarate

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating finerenone, a drug that blocks a protein involved in inflammation and scarring, to see if it helps children with heart failure and left ventricular systolic dysfunction (LVSD). Heart failure is a serious condition where the heart cannot pump enough blood, causing symptoms like shortness of breath, fatigue, and poor growth. This Phase 3 study is the first to explore finerenone's effects specifically in children aged 6 months to under 18 years with these heart problems. The goal is to determine if finerenone improves heart function compared to a placebo by measuring levels of a heart stress protein called NT-proBNP and monitoring safety. Participants will be randomly assigned to receive either finerenone or a placebo for about 90 days, while continuing their standard heart failure treatments. The study includes a double-blind design, meaning neither the participants nor the researchers know who receives the active drug or placebo during this period. After the initial three-month treatment, eligible participants may join a nine-month open-label extension where all receive finerenone. Those not entering the extension will have a follow-up visit 30 days after finishing treatment. Throughout the study, participants will visit the study site at least three times for assessments including vital signs, heart exams with ECG and echocardiogram, blood tests, physical exams, and interviews about their medication and any medical problems. Researchers will track all adverse events, which are any health issues occurring during the study, regardless of relation to the treatment. The main outcome measured is the change in NT-proBNP from the start to the end of treatment, helping to evaluate the drug's effect on heart stress.

Researchers are evaluating how the study medicine PF-06823859 (dazukibart) works in adults with active idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM). These rare diseases cause muscle inflammation that weakens muscles important for movement, and DM may also cause a characteristic skin rash. The study aims to understand the safety and effectiveness of dazukibart compared to placebo in this patient group. Participants will receive either the study medicine or a placebo, both given as intravenous (IV) infusions lasting about 1 hour. These infusions will be administered every 4 weeks from the first day up to Week 48 at the study site. The study includes a total duration of about 13 months with 15 visits to the study site for treatment and monitoring. During the study, participants will be monitored through regular visits where researchers will assess their health and response to treatment. The main outcome measured is the moderate change in the Total Improvement Score (TIS) at 24 weeks for sites outside the United States and at 52 weeks for sites within the United States. Safety and other health evaluations will be conducted throughout the study to understand how participants respond to the study medicine compared to placebo.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.

Researchers are evaluating the safety, tolerability, and how the body responds to the drug BMS-986435/MYK-224 in adults with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF), a condition where the heart's pumping ability remains normal despite heart failure symptoms. This Phase 2A study aims to better understand the drug's effects and levels in the body in this specific group of heart failure patients. Participants will receive either BMS-986435 or a placebo, each given at specified doses on certain days. The study is designed as a double-blind, randomized, placebo-controlled trial conducted at multiple centers, ensuring unbiased evaluation of the drug's effects. The treatment period lasts approximately 24 weeks. During the study, participants will be closely monitored for any adverse events, including serious side effects and those that might lead to stopping treatment. The primary outcomes include tracking the incidence of these adverse events up to 24 weeks, with safety and tolerability being the main focus. Participants will be adults aged 40 to 85 with stable, symptomatic HFpEF, and the total involvement will cover the treatment and monitoring periods described.