Warendorf

This research aims to evaluate the safety and effectiveness of a drug called DII235 in adults who have high levels of lipoprotein(a), a condition linked to lipoprotein disorder. The study focuses on adults aged 18 to 80 years who also have evidence of atherosclerotic cardiovascular disease or type 2 diabetes. This is a Phase 2 study designed to identify the best dose of DII235 and understand its impact on lipoprotein(a). Participants will be randomly assigned to receive either DII235 or a placebo in a controlled, double-blind manner to ensure unbiased results. The study involves administering DII235 or a saline placebo as solutions for injection. The trial is designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study. Participants will receive different doses of DII235 or the placebo, and their responses will be compared over time to evaluate the drug's effects on lipoprotein(a) levels. The dosing and treatment schedules are carefully monitored to assess the safety, tolerability, and appropriate dosage levels of DII235. Participants will be followed and evaluated through various assessments, including measuring the percentage change from their baseline lipoprotein(a) levels between Day 60 and Day 180, and also between Day 60 and Day 360 for different doses. Safety and tolerability will be closely monitored throughout the study duration. The trial includes regular laboratory testing and clinical evaluations to track participant health and treatment response. Overall participation in the study spans several months to capture both short-term and longer-term effects of the treatment.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

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.