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

Open to people ages 18 years and up

:

• 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
• Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
• Participants with medical history of hypertension and on active pharmacological treatment
• Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment
• Established cardiovascular (CV) disease and on active pharmacological treatment
• At least one additional risk factor for developing heart failure (HF)

• History of HF or hospitalization for HF or treatment of HF
• Atrial fibrillation or Atrial flutter with a resting heart rate >110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)
• Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)
• Treatment with an Mineralocorticoid receptor antagonist (MRA)
• Treatment with amiloride or other potassium-sparing diuretic
• Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:
  • A direct renin inhibitor (e.g. aliskiren)
  • More than one Angiotensin-converting enzyme inhibitor (ACEi) and/or Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously
  • Other aldosterone synthase inhibitors (e.g. baxdrostat)

  • Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further

    exclusion criteria apply.