Pancevo

Researchers are evaluating the safety and effectiveness of the drugs eltrekibart and mirikizumab in adults with moderately to severely active ulcerative colitis UC, a chronic inflammatory bowel disease. This Phase 2 study aims to find out how these treatments work alone or in combination to improve UC symptoms and health. The study is sponsored by Eli Lilly and Company and will last about 4 to 5 years, including screening. Participants will be randomly assigned to receive one of several treatments eltrekibart with a placebo, mirikizumab with a placebo, both drugs together, or placebo alone. The study is double-blinded, meaning neither the participants nor the researchers know which treatment is given to ensure unbiased results. The treatment period includes dosing with the study drugs or placebo, and participants will be monitored for safety and response. Participants will be involved in the trial for around 69 weeks, including a screening period of up to 35 days before starting treatment. Throughout the study, they will undergo assessments to measure clinical remission, response, endoscopic improvement, and quality of life using questionnaires. Blood samples will be taken to study drug levels, and researchers will monitor safety and disease activity regularly. The main outcome is the percentage of participants achieving clinical remission at Week 12, with additional measures assessed up to Week 52.

Researchers are studying the effects of ACM-001.1, a drug taken alongside semaglutide, on muscle loss and muscle gain in adults with obesity. Semaglutide is already approved for weight management, but it can cause loss of muscle mass. This phase 2a study aims to assess how ACM-001.1 impacts lean body mass during and after semaglutide treatment in obese patients. The study consists of two 20-week parts separated by a 4-week break without treatment. Participants receive either semaglutide injections or sham fake injections weekly, alongside oral tablets of ACM-001.1 or placebo, taken twice daily. Two doses of ACM-001.1 are tested, and participants are randomly assigned to different groups in a crossover design to compare the effects during semaglutide therapy and after stopping semaglutide. Participants will undergo DEXA scans to measure body composition, heart tests, muscle function tests including handgrip strength, and complete health questionnaires. Blood samples will be collected to monitor overall health. The main outcome is the change in lean body mass during and after semaglutide treatment. The total study duration is about 18 months with close monitoring and questionnaires throughout.

Researchers are assessing how a decentralized treatment model affects treatment adherence in people with early-stage HER2-positive breast cancer. The study compares patients who have consistent travel requirements for their adjuvant therapy with those who face increased travel burdens, aiming to understand the impact on treatment patterns and quality of life. Participants are divided into two main groups based on their travel burden during adjuvant therapy. Group 1 includes Cohorts A, C, and D, where treatment location does not increase travel needs, while Group 2 includes Cohort B, where patients must travel from a secondary to a tertiary center. All treatment decisions are made by the treating physician and participant following routine clinical practice without additional interventions mandated by the study. During the study, participants are observed for treatment adherence, completion rates, delays in dosing, travel burden, and quality of life using questionnaires like the EORTC QLQ-C30. Data on timing of neoadjuvant treatment, surgery, and adjuvant treatment initiation are collected. The study will follow participants for up to 2.25 years to monitor these outcomes and understand the effects of treatment decentralization.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

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 evaluating plozasiran in adults with severe hypertriglyceridemia SHTG who have experienced at least two prior acute pancreatitis AP events, with one event occurring within the last 12 months before screening. The study aims to assess the efficacy and safety of plozasiran compared to a placebo in reducing AP events and managing triglyceride levels. About 288 adult participants will be involved in this randomized, double-blind, phase 3 clinical trial. Participants will be randomly assigned to receive either plozasiran 25 mg or a matching placebo by subcutaneous injection every three months Q3M. They will be counseled to maintain a low-fat diet and continue their prescribed lipid and triglyceride-lowering medications throughout the study. After the double-blind treatment period or upon experiencing a confirmed AP event, participants will enter a 12-month open-label extension, receiving plozasiran 25 mg by subcutaneous injection every three months. During the study, participants will be regularly monitored for the time to first AP event, changes in fasting serum triglyceride levels, cardiovascular events, patient-reported productivity, and health status. Safety assessments will include tracking treatment-emergent adverse events. The study will last approximately up to 62 months, including the double-blind and open-label phases, with ongoing evaluations and follow-up visits to assess treatment effects and participant health.