Pancevo

Researchers are evaluating the safety and effectiveness of two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis (UC). This study is a phase 2 trial lasting about 4 to 5 years, aiming to understand how well these treatments work alone or together for this chronic condition. Participants will receive either eltrekibart alone, mirikizumab alone, a combination of both, or a placebo. The treatments are administered as drugs, and the study includes a screening period of up to 35 days before enrollment. The total participation time for each person is approximately 69 weeks, which includes the screening and treatment periods. During the trial, participants will be closely monitored to assess the percentage who achieve clinical remission by week 12. Researchers will conduct regular evaluations, which may include medical assessments and questionnaires, to track the safety and effects of the treatments. The study emphasizes careful follow-up to ensure participant safety and to gather detailed information about the therapies over the entire study duration.

Researchers are investigating the impact of ACM-001.1, a study drug, on muscle mass in adults with obesity who are receiving semaglutide for weight management. The study focuses on how ACM-001.1 affects muscle loss during semaglutide use (PROACT 1) and muscle gain after semaglutide treatment stops (PROACT 2). This two-part, phase 2a clinical trial explores these effects to better understand muscle changes associated with weight loss treatments. Participants will receive either ACM-001.1 or a placebo tablet twice daily, while also receiving weekly injections of semaglutide or a sham injection. The study includes two 20-week treatment periods separated by a 4-week washout without treatment. Neither the patients nor the doctors will know who receives ACM-001.1 or placebo, nor the dose level of ACM-001.1, ensuring a double-blind design. During the study, muscle mass changes will be measured using DEXA scans, along with assessments of weight, heart function, and muscle strength. Participants will complete health and well-being questionnaires, and blood tests will monitor overall health. The primary outcome is the change in lean body mass over 20 weeks during and after semaglutide treatment. The entire study is expected to last about 18 months.

Researchers are evaluating how a decentralized treatment model affects treatment adherence in women with early-stage human epidermal growth factor receptor 2-positive (HER2+) breast cancer. The study focuses on participants diagnosed with stage II and III HER2+ breast cancer who have undergone curative surgery. The purpose is to compare treatment adherence between groups facing different travel requirements for their adjuvant therapy. The study divides participants into two groups based on their travel burden. Group 1 includes participants whose travel requirements for adjuvant therapy remain consistent, while Group 2 consists of those who must travel from a secondary center to a tertiary center for treatment. The study monitors how these different treatment locations impact adherence to therapy over time. Participants will be followed to measure their treatment adherence rates for up to 2.25 years. The research involves assessing adherence patterns and treatment consistency. Researchers will collect relevant data from the participating study sites in Serbia, focusing on real-world treatment patterns and adherence after decentralization of care.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

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 effectiveness and safety of plozasiran in about 288 adults who have severe hypertriglyceridemia (high levels of triglycerides in the blood) and a history of at least two acute pancreatitis events, with at least one occurring within the last year before screening. This Phase 3 study compares plozasiran to a placebo in a double-blind manner to better understand its impact on reducing pancreatitis risk in this population. Participants will be randomly assigned to receive either plozasiran 25 mg or a matching placebo through subcutaneous injections every three months. They will be advised to continue a low-fat diet and maintain their usual lipid- and triglyceride-lowering medications throughout the study. After completing the double-blind treatment period or experiencing an acute pancreatitis event, participants will enter a 12-month open-label phase where all receive plozasiran 25 mg injections every three months. During the study, participants will be monitored for the time until their first confirmed acute pancreatitis event starting more than 10 days after the first dose, with follow-up lasting up to approximately 50 months. Researchers will assess treatment effects, safety, adherence to diet and medications, and overall participant health. The study includes regular evaluations to ensure participant safety and collect data on the treatment's impact on severe hypertriglyceridemia and pancreatitis risk.