EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease

This study is looking for adults aged 18 or over. You might be able to join if you have type 2 diabetes, high blood pressure, and heart disease, and you are already taking medicines for these conditions.

However, you can't take part if you've ever had heart failure, or if you have certain serious heart rhythm problems that aren't treated. Also, if you're currently taking specific types of blood pressure or heart medicines, or if you need to start them soon, you might not be eligible. This includes medicines like MRAs, amiloride, or certain combinations of ACEi/ARBs. Women who can have children must agree to use effective birth control throughout the study.

If you join this study, you'll be in it for up to 4 years and 3 months. For the first 2 and a half years, you'll be taking a study tablet once a day. This tablet will either contain the active medicine called vicadrostat, or it will be a dummy pill (placebo) that looks exactly the same but contains no medicine. You'll have an equal chance of getting either one, as this is decided randomly, like flipping a coin. Importantly, you'll continue taking all your usual medicines for your type 2 diabetes, high blood pressure, and heart disease throughout the study.

During this time, you'll have regular visits to the study clinic. At these visits, the doctors and nurses will check your health carefully, and you'll have blood samples taken. They will also keep a close eye on your heart health and ask about any new or unwanted effects you might experience. These regular check-ups help the researchers understand how the study medicine is affecting your body and whether it's helping or causing any side effects.