Krapinske Toplice

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

Researchers are evaluating the changes in symptoms and functional limitations in adults with symptomatic hypertrophic cardiomyopathy (HCM), including both obstructive and non-obstructive types. This Phase 3 trial aims to compare the effects of sotagliflozin, an oral medication, to a placebo in these participants. The study focuses on how these treatments affect heart-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS) over 26 weeks. Participants will be randomly assigned to receive either sotagliflozin tablets or matching placebo tablets once daily. The study includes participants with specific heart function criteria, including left ventricular outflow tract gradients for obstructive or non-obstructive HCM and stable background therapy. The treatment period lasts 26 weeks, during which participants take the assigned tablets daily. Throughout the study, participants will undergo assessments including symptom evaluations and functional status measurements. Researchers will monitor changes from the start of the study to week 26 using the KCCQ CSS to evaluate treatment effects on heart symptoms and quality of life. Safety and adherence to medication will also be observed during this time.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for treating adults who have excess body weight and type 2 diabetes. This Phase 3 clinical trial compares NNC0487-0111 with a placebo to see how well it helps participants lose weight. The study focuses on adults diagnosed with type 2 diabetes at least 180 days before screening, who have a specific range of blood sugar levels (HbA1c between 7-10%). Participants receive treatments as weekly injections under the skin using a pre-filled pen injector (PDS290) applied to the thigh, abdomen, or upper arm. They are randomly assigned to receive either NNC0487-0111 or a placebo that looks like the active treatment but contains no medicine. The study treatments are given once a week throughout the trial. During the study, participants are monitored for changes in their body weight from the start of the trial up to week 84. Researchers also assess safety and other health measures. Participants continue their usual treatment with lifestyle changes or certain oral diabetes medications that have been stable before joining. The trial follows them closely to evaluate how the treatment affects their weight and diabetes control over time.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.