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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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 years
  • Procedures mentioned: Pills, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin."
  • "Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months."
  • "Participants are in the study for up to 4 years and 3 months."
  • "During these visits, doctors collect information about participants' health and take blood samples."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether vicadrostat taken with empagliflozin lowers the risk of heart and blood vessel problems compared with a placebo taken with empagliflozin. A placebo looks like medicine but has no medicine in it. The study is for adults with type 2 diabetes, high blood pressure, and heart or blood vessel disease who have never had heart failure.

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. 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Sign and date a form agreeing to join the study.
  • If you can become pregnant, be willing and able to use highly effective birth control.
  • Have high blood pressure and take medicine for it.
  • Have type 2 diabetes and take medicine for it.
  • Have heart or blood vessel disease and take medicine for it.
  • Have at least one more risk factor for heart failure, when the heart does not pump blood well enough.

Who can't join

  • Have ever had heart failure, been in the hospital for it, or been treated for it.
  • Have atrial fibrillation or atrial flutter (types of abnormal heartbeat) with a resting heart rate over 110 beats per minute at screening.
  • Have a serious untreated problem with the heart's electrical signals or a significant untreated abnormal rhythm in the heart's lower chambers at screening.
  • Take a mineralocorticoid receptor antagonist (MRA), a medicine that blocks a hormone's effects.
  • Take amiloride or another potassium-sparing diuretic, a water pill that helps your body keep potassium.
  • Take, need before group assignment, or plan to take a direct renin inhibitor such as aliskiren, or more than one ACE inhibitor or ARB at once (including an ARNI). These are types of blood pressure or heart medicines.
  • Take, need before group assignment, or plan to take another aldosterone synthase inhibitor such as baxdrostat (which lowers a hormone), or mineralocorticoid hormone replacement such as fludrocortisone.
  • Other rules may also prevent you from joining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (208)

AL

AZ

CA

CO

CT

FL

GA

HI

ID

IL

IN

KS

KY

LA

MA

MD

MI

MO

MS

MT

NC

ND

NE

NJ

NM

NV

NY

OH

OK

PA

SC

SD

TN

TX

UT

VA

WA

WI

WV