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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
EU CTIS ID: 2025-521188-11-00
What this study is testing
The primary objective is to demonstrate the superiority of the combination of vicadrostat and empagliflozin compared with vicadrostat-placebo and empagliflozin for the time to first CV death, HHF, or urgent HF visit in participants with T2DM, HTN and established CVD.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- 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)
- Treatment with an 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: 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)
See the full eligibility 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
- 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
- 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)
- Treatment with an 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: 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)
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong
- China
- Serbia
- Thailand
- Taiwan
- Canada
- Vietnam
- Japan
- Korea, Republic of
- Malaysia
- Mexico
- United States
- South Africa
- New Zealand
- Israel
- United Kingdom
- Philippines
- Brazil
- Colombia
- Saudi Arabia
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong; China; Serbia; Thailand; Taiwan; Canada and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.