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

Prior treatment

• Treatment with an MRA
• Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial: o A direct renin inhibitor (e.g. aliskiren) o More than one ACEi and/or ARB (including ARNi) used simultaneously o Other aldosterone synthase inhibitors (e.g. baxdrostat) o Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone)

Other illness

• History of HF or hospitalization for HF or treatment of HF
• Atrial fibrillation or Atrial flutter with a resting heart rate >110 bpm documented by ECG at Visit 1 (screening)
• Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)

Lab values

• Treatment with amiloride or other potassium-sparing diuretic

Other

• Further exclusion criteria apply.

• At least 18 years old at time of consent
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
• Male or female participants. WOCBP (see Section 4.2.2.3) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
• Participants with medical history of hypertension and on active pharmacological treatment according to best possible SOC in accordance with applicable local/international guidelines (according to the judgment of the investigator)
• Participants with medical history of T2DM and on active pharmacological treatment according to best possible SOC in accordance with applicable local/international guidelines (according to the judgment of the investigator)
• Established CV disease and on active pharmacological treatment according to best possible SOC in accordance with applicable local/international guidelines (according to the judgment of the investigator).
• At least one additional risk factor for developing HF