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Taking people in SerbiaPhase 3

Tests vicadrostat with empagliflozin in adults with type 2 diabetes and heart disease

Tests vicadrostat taken with empagliflozin in adults with diabetes, high blood pressure and heart disease.

Key facts

Who runs it
Boehringer Ingelheim
Where
Belgrade, Kamenitz, Kragujevac, Niška Banja, and Pančevo, SerbiaSee the 7 sitesAlso in 50 other countries, 1,126 sites
Trial code
Registry title
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
Status
Recruiting
Phase
Phase 3
People taking part
11,800 people, planned
Started
22 Jul 2025
Expected to end
21 Dec 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Vicadrostat
  • Empagliflozin
  • Placebo matching Vicadrostat
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes, high blood pressure and established cardiovascular disease who have never had heart failure.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Type 2 diabetes, high blood pressure and established cardiovascular disease, with at least one more risk factor for developing heart failure. No history of heart failure.
Earlier treatment
People must be on active medicine treatment for high blood pressure, type 2 diabetes and cardiovascular disease. People cannot join if they are treated with a mineralocorticoid receptor antagonist (MRA), amiloride or another potassium-sparing diuretic.

Main reasons for not taking part

  • History of heart failure, hospital stay for heart failure, or heart failure treatment
  • Atrial fibrillation or flutter with a resting heart rate above 110 beats per minute at screening
  • Advanced untreated conduction disease or untreated relevant ventricular arrhythmia
  • Treatment with an MRA, amiloride or another potassium-sparing diuretic
  • Taking a direct renin inhibitor, more than one ACE inhibitor or ARB together, or another aldosterone synthase inhibitor

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Treatment with an Mineralocorticoid receptor antagonist (MRA)
  • 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
  • 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 amiloride or other potassium-sparing diuretic

Where in Serbia

Also in 50 other countries, 1,126 sites

  • Clinical Hospital Center Dr. Dragisa MisovicBelgrade, SerbiaContact: Boehringer IngelheimTaking people
  • Clinical. Hospital Center ZvezdaraBelgrade, SerbiaContact: Boehringer IngelheimTaking people
  • University Clinical Center of SerbiaBelgrade, SerbiaContact: Boehringer IngelheimTaking people
  • Institute of Cardiovascular Diseases of VojvodineKamenitz, SerbiaContact: Boehringer IngelheimTaking people
  • University Clinical Center of KragujevacKragujevac, SerbiaContact: Boehringer IngelheimTaking people
  • Institute for Treatment and Rehabilitation, Niska BanjaNiška Banja, SerbiaContact: Boehringer IngelheimTaking people
  • General Hospital PancevoPančevo, SerbiaContact: Boehringer IngelheimTaking people

About the trial

What the trial wants to find out

This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.

Read full original descriptionShow less

Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine.

Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo.

Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.

The 2 groups in the trial

  • Vicadrostat + empagliflozin treatment armTreatment being tested

    Treatment: Vicadrostat and Empagliflozin

  • Vicadrostat-placebo + empagliflozin treatment armExisting treatment, for comparison

    Treatment: Empagliflozin and Placebo matching Vicadrostat

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests vicadrostat with empagliflozin in adults with type 2 diabetes and heart diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 November 2026