Zarate

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 orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are studying finerenone, a drug under development, to treat newborns, children, and young adults with heart failure caused by left ventricular systolic dysfunction LVSD. LVSD weakens the left side of the heart, making it hard to pump blood properly, which can cause symptoms such as shortness of breath, tiredness, and poor growth. This Phase 3 study aims to evaluate the long-term safety and effects of finerenone when added to standard heart failure treatment in this young population, including those rolling over from a previous study and newly enrolled newborns under 6 months old. Participants will receive finerenone treatment for up to 9 months, alongside their usual heart failure care. The study will follow them for around 10 to 11 months, depending on their enrollment status. During this time, they will attend at least six visits where the study team will monitor vital signs, take blood samples, perform physical exams, and use heart imaging tests like electrocardiograms and echocardiography. Parents or guardians will also provide feedback on medication use and, for newborns and infants, on the drugs formulation acceptability. Throughout the study, researchers will track any medical problems that arise, changes in blood potassium levels, blood pressure, and kidney function. They will also measure heart function and levels of NT-proBNP, a marker related to heart failure. After finishing treatment, participants will have a follow-up health check one month later. This careful monitoring helps the team understand the safety and effects of finerenone in children and young adults with heart failure and LVSD.

Researchers are investigating a new treatment for children with heart failure and left ventricular systolic dysfunction LVSD, a condition where the heart cannot pump enough blood. This study aims to find out if finerenone, a drug that blocks a protein involved in heart and blood vessel damage, can help improve heart function compared to a placebo. This is the first study to test finerenone specifically in children with these heart problems. Participants aged 6 months to less than 18 years with heart failure and LVSD will be randomly assigned to receive either finerenone or a placebo for about 3 months, while continuing their usual heart failure care. After this period, those who qualify can join a 9-month open-label extension where everyone receives finerenone. Participants not joining the extension will have a follow-up visit 30 days after their last treatment. During the study, children will visit the study site at least three times for physical exams, heart tests like ECG and echocardiogram, blood pressure and vital sign checks, blood samples, and medication and side effect reviews. Researchers will measure changes in NT-proBNP, a protein indicating heart stress, and monitor safety through tracking adverse events and other heart and kidney function tests. The total participation can last up to approximately one year including the extension phase.

Researchers are evaluating how the study medicine PF-06823859 dazukibart works in adults with idiopathic inflammatory myopathies, specifically dermatomyositis DM and polymyositis PM. These conditions cause muscle inflammation leading to weakness and may include a skin rash in DM. The study aims to assess the safety and effects of dazukibart compared to a placebo in people receiving stable doses of corticosteroids or immunosuppressants. Participants will receive either the study medicine or a placebo through an intravenous infusion lasting about one hour. These infusions occur every four weeks from Day 1 through Week 48 at the study site. The study is randomized and double-blind, meaning neither participants nor researchers know who gets the medicine or placebo during the trial. Participants will be involved for about 13 months, attending 15 visits at the study site. During these visits, muscle strength, skin condition, physical function, fatigue, itch, and corticosteroid use are assessed. The main measurement is the Total Improvement Score at 24 or 52 weeks depending on location. Safety and other symptom measures will be monitored throughout the study period.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are studying the effects of ribupatide KAI-9531, given as a weekly subcutaneous injection, in adults living with obesity or overweight who also have type 2 diabetes. The main goal is to see if ribupatide is better than a placebo in reducing body weight and lowering hemoglobin A1c HbA1c, a key marker of blood sugar control. This is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating safety and efficacy. Participants will be randomly assigned to receive one of four doses of ribupatide or a matching placebo once weekly. The study compares the effects of these different doses over time, focusing on changes in weight and HbA1c levels at week 76. The intervention involves subcutaneous injections administered once a week, with multiple doses tested to evaluate their impact relative to placebo. During the study, participants will be monitored regularly to measure changes in body weight, HbA1c, waist circumference, blood pressure, cholesterol levels, glucose, insulin, and quality of life related to weight. Safety assessments include tracking adverse events and immune responses to the drug. Blood samples will be collected to measure ribupatide concentrations. The study lasts up to 76 weeks, with ongoing monitoring for treatment effects and safety throughout this period.

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 maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.