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Vicadrostat with empagliflozin for people with type 2 diabetes, high blood pressure, and heart disease

EASi-PROTKT™ - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Type 2 Diabetes, Hypertension and Established Cardiovascular Disease

Phase 3 Interventional Boehringer Ingelheim · NCT07064473

This trial will test whether adding vicadrostat to empagliflozin lowers cardiovascular risk in adults who have type 2 diabetes, high blood pressure, and existing cardiovascular disease but no history of heart failure.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment11800 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations1153 sites (Anniston, Alabama and 1152 other locations)
Trial IDNCT07064473 on ClinicalTrials.gov

What this trial studies

Adults who meet the criteria are randomly assigned to one of two groups: vicadrostat plus empagliflozin or a placebo matching vicadrostat plus empagliflozin. Participants take one tablet daily and continue their usual medications for diabetes, blood pressure, and cardiovascular disease. Treatment and follow-up continue for a minimum of about 2½ years and up to roughly 4 years and 3 months to track cardiovascular outcomes. The study is placebo-controlled with matching tablets to maintain blinding between the active and placebo vicadrostat groups.

Who should consider this trial

Good fit: Adults aged 18 or older with treated type 2 diabetes, treated hypertension, established cardiovascular disease, no history of heart failure, and at least one additional heart-failure risk factor are the intended participants.

Not a fit: People with a history of heart failure, recent hospitalization for heart failure, certain uncontrolled arrhythmias, untreated significant conduction disease, or who cannot take empagliflozin or vicadrostat are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the combination could lower cardiovascular events and overall cardiovascular risk for people with type 2 diabetes and high blood pressure who already have heart disease.

How similar studies have performed: SGLT2 inhibitors like empagliflozin have shown clear cardiovascular benefits in prior studies, but vicadrostat is a newer agent and combining it with empagliflozin at this scale is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria :

* 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)

Exclusion Criteria:

* 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.

Where this trial is running

Anniston, Alabama and 1152 other locations

+1103 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Mellitus, Type 2HypertensionCardiovascular Diseases
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.