Saket

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 safety, pharmacokinetics, and pharmacodynamics of oral AUR112 in patients with relapsed advanced lymphomas. This Phase 1, open-label, dose escalation study aims to assess the tolerability of AUR112 and determine the doses suitable for future trials. The study involves patients with relapsed Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Hodgkin disease who have exhausted other effective therapies locally. Participants will receive AUR112 once daily, with dose escalation following a classic 3+3 design. Dose escalation continues until safety limits are reached or pharmacokinetic and pharmacodynamic data indicate a biologically active dose. The study monitors dose limiting toxicities and treatment-related adverse events, alongside detailed pharmacokinetic measurements at specified time points. During the study, participants will be closely monitored through clinical assessments and laboratory tests to evaluate safety and drug behavior in the body. Key outcomes include dose limiting toxicities within the first treatment cycle, adverse events graded by standard criteria, and pharmacokinetic parameters such as maximum concentration and half-life. The study also evaluates safety under fasting and fed conditions over a 28-day treatment cycle.