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.
Plain-language title generated from the registry record
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
Key facts
- Where
- Bad Homburg, Bad Krozingen, Bad Oeynhausen, Berlin, Bochum, Bremen, Bruchsal, Coburg, Cologne, Dachau, Darmstadt, Dortmund, Dresden, Duesseldorf, Duisburg, Eisenach, Erfurt, Essen, Freiburg im Breisgau, Friedrichsthal, Gladbeck, Goslar, Hamburg, Hassloch, Heidelberg, Herne, Homburg, Kaiserslautern, Kassel, Köln, Leipzig, Ludwigsburg, Ludwigshafen am Rhein, Lüneburg, Magdeburg, Mainz, Mannheim, Markkleeberg, Moenchengladbach, Muenster, Mühldorf am Inn, München, Münster, Neuwied, Nürnberg, Obertshausen, Offenbach Am Main, Oldenburg in Holstein, Paderborn, Papenburg, Penzberg, Potsdam, Reinfeld, Riesa, Rostock, Rotenburg, Singen (Hohentwiel), Straubing, Stuhr, Stuttgart, Trier, Ulm, Wangen im Allgäu, Weinheim, Wermsdorf, Witten, Worms, Zwenkau, and Zwickau, GermanySee the 91 sites
- Phase
- Phase 3
Where in Germany
- Zentrum für Klinische StudienBad Homburg, GermanyTaking people
- Medical Center - University Of FreiburgBad Krozingen, GermanyTaking people
- Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet BochumBad Oeynhausen, GermanyTaking people
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- FutureMeds GmbHBerlin, GermanyTaking people
- KARDIA - Dr. HashemiBerlin, GermanyTaking people
- Medizinisches Zentrum Kardiologie im SpreebogenBerlin, GermanyTaking people
- Policum Berlin Studien GmbHBerlin, GermanyTaking people
- Sana Kliniken Berlin-Brandenburg GmbHBerlin, GermanyTaking people
- Velocity Clinical Research Germany GmbHBerlin, GermanyTaking people
- Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil gGmbHBochum, GermanyTaking people
- Diabetes- und Stoffwechselpraxis BochumBochum, GermanyTaking people
- Cardio Consult GbRBremen, GermanyTaking people
- RKH Regionale Kliniken Holding und Services GmbHBruchsal, GermanyTaking people
- SANA Kliniken Oberfranken Coburg GmbHCoburg, GermanyTaking people
- Universitaetsklinikum Koeln AöRCologne, GermanyTaking people
- Medizinisches Versorgunszentrum DachauDachau, GermanyTaking people
- KVZ Kardiovaskulaeres Zentrum Darmstadt GmbHDarmstadt, GermanyTaking people
- Kath. St. Paulus GmbHDortmund, GermanyTaking people
- Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbHDresden, GermanyTaking people
- Herzzentrum Dresden GmbH UniversitaetsklinikDresden, GermanyTaking people
- Technische Universitaet DresdenDresden, GermanyTaking people
- Deutsche Diabetes Forschungsgesellschaft e.V.Duesseldorf, GermanyTaking people
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, GermanyTaking people
- StudyPoint Duisburg GbRDuisburg, GermanyTaking people
- Praxis für Diabetologie, Angiologie und Innere Medizin EisenachEisenach, GermanyTaking people
- Katholische Hospitalvereinigung Thueringen gGmbHErfurt, GermanyTaking people
- Elisabeth-Krankenhaus Essen GmbHEssen, GermanyTaking people
- InnoDiab Forschung GmbhEssen, GermanyTaking people
- Klinisches Forschungszentrum Dr. Hagemann am Hausarztzentrum am GermaniaplatzEssen, GermanyTaking people
- Studienzentrum BocholderstrasseEssen, GermanyTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
- Gemeinschaftspraxis Denger & PfitznerFriedrichsthal, GermanyTaking people
- Hausarztzentrum ButendorfGladbeck, GermanyTaking people
- Asklepios Harzkliniken GmbHGoslar, GermanyTaking people
- Cardiologicum Hamburg GbRHamburg, GermanyTaking people
- Diabetes Zentrum Wilhelmsburg GbRHamburg, GermanyTaking people
- University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
- Velocity Clinical Research Germany GmbHHamburg, GermanyTaking people
- Kardiologie HasslochHassloch, GermanyTaking people
- St. Josefskrankenhaus Heidelberg GmbHHeidelberg, GermanyTaking people
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-RuhrHerne, GermanyTaking people
- Universitaet Des SaarlandesHomburg, GermanyTaking people
- Kardiopraxis SchirmerKaiserslautern, GermanyTaking people
- B. Braun Ambulantes Herzzentrum Kassel MVZ GmbHKassel, GermanyTaking people
- Zentrum fuer klinischen ForschungKöln, GermanyTaking people
- Familienmedizinisches Zentrum RadowskyLeipzig, GermanyTaking people
- Herzzentrum Leipzig GmbHLeipzig, GermanyTaking people
- Velocity Clinical Research Germany GmbHLeipzig, GermanyTaking people
- CCLB Ludwigsburg-BietigheimLudwigsburg, GermanyTaking people
- Kardiologische Praxis LudwigshafenLudwigshafen am Rhein, GermanyTaking people
- Praxis OedemeLüneburg, GermanyTaking people
- Institut Fuer Praeventive Medizin & Klinische Forschung GbRMagdeburg, GermanyTaking people
- Cardiopraxis Mainz IngelheimMainz, GermanyTaking people
- PSHI Praxis GmbHMainz, GermanyTaking people
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyTaking people
- ze:ro Praxen MVZ fuer Nierenerkrankungen und Bluthochdruck GmbH MannheimMannheim, GermanyTaking people
- Kardiologische Praxis Dr. TaggeselleMarkkleeberg, GermanyTaking people
- Kliniken Maria Hilf GmbH MoenchengladbachMoenchengladbach, GermanyTaking people
- Institut fuer Diabetesforschung Muenster GmbHMuenster, GermanyTaking people
- Praxis Herznah Dr. med. Prohaska und Dr. med. SchulteMühldorf am Inn, GermanyTaking people
- CDG-Studienambulanz Dr. HartardMünchen, GermanyTaking people
- Praxis Dr. Schriek GIKMünster, GermanyTaking people
- Marienhaus Klinikum St. Elisabeth NeuwiedNeuwied, GermanyTaking people
- MCN Medic Center Nürnberg GmbHNürnberg, GermanyTaking people
- Rahman & Detho Studien GmbHObertshausen, GermanyTaking people
- FutureMeds GmbHOffenbach Am Main, GermanyTaking people
- R.E.D. Institut fuer medizinische Studien und Fortbildung GmbHOldenburg in Holstein, GermanyTaking people
- St. Vincenz-Krankenhaus GmbHPaderborn, GermanyTaking people
- Dr. med. Andreas Wilke Dr. med. Andrej Malazhavy und Detelin Lalev Denchev Fachaerzte Innere Medizin und Kardiologie PartnerschaftPapenburg, GermanyTaking people
- Kardiologie Isar-Loisachtal - Dres. N. Eberl /T. Pohl /P.M. Rumpf / J. BlumensteinPenzberg, GermanyTaking people
- Kardiologische Gemeinschaftspraxis am Park SanssouciPotsdam, GermanyTaking people
- Praxis Reinfeld MitteReinfeld, GermanyTaking people
- Studienzentrum Dr. Tasso BielerRiesa, GermanyTaking people
- Rostock University Medical CenterRostock, GermanyTaking people
- Nierenzentrum RotenburgRotenburg, GermanyTaking people
- Gesundheitsverbund Landkreis Konstanz gGmbHSingen (Hohentwiel), GermanyTaking people
- Barmherzige Brueder gemeinnuetzige Traeger GmbHStraubing, GermanyTaking people
- Kardiologische Praxis im Steiner ThorStraubing, GermanyTaking people
- Praxisgemeinschaft MelcherstätteStuhr, GermanyTaking people
- Robert Bosch Gesellschaft fuer medizinische Forschung mbHStuttgart, GermanyTaking people
- Barmherzige Brueder Trier gGmbHTrier, GermanyTaking people
- Praxis Dr. Astrid Schmidt-ReinwaldTrier, GermanyTaking people
- Universitaetsklinikum Ulm AoRUlm, GermanyTaking people
- Zentrum für Klinische Forschung Allgäu OberschwabenWangen im Allgäu, GermanyTaking people
- Medislim GmbHWeinheim, GermanyTaking people
- Kardiologische Praxis Dr. med. Ayham Al-Zoebi WermsdorfWermsdorf, GermanyTaking people
- Evangelisches Krankenhaus Witten gGmbHWitten, GermanyTaking people
- Klinikum Worms gGmbHWorms, GermanyTaking people
- Praxis Fuer Innere MedizinZwenkau, GermanyTaking people
- Heinrich-Braun-Klinikum Zwickau gGmbHZwickau, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Boehringer Ingelheim
- Trial code
- NCT07064473EU 2025-521188-11-00
- Record updated
- 28 October 2026
- Original description
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
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
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.
Inclusion: 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: 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.