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
- Acquaviva delle Fonti, Ancona, Bergamo, Brescia, Catania, Catanzaro, Chieti, Cosenza, Ferrara, Florence, L'aquila, Milan, Monza, Naples, Palermo, Pavia, Pisa, Rivoli, Rome, Savona, Trieste, Turin, and Varese, ItalySee the 29 sites
- Phase
- Phase 3
Where in Italy
- Ente Ecclesiastico ospedale generale Regionale MiulliAcquaviva delle Fonti, ItalyTaking people
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- ARNAS Garibaldi Di CataniaCatania, ItalyTaking people
- University Magna Graecia of CatanzaroCatanzaro, ItalyTaking people
- Azienda Sanitaria Locale 2 Lanciano Vasto ChietiChieti, ItalyTaking people
- Azienda Ospedaliera-Universitaria Di CosenzaCosenza, ItalyTaking people
- University Hospital Of FerraraFerrara, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Azienda Sanitaria Locale Avezzano Sulmona L'AquilaL'aquila, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Multimedica S.p.A.Milan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
- Università degli studi di Napoli Federico IINaples, ItalyTaking people
- ARNAS Civico Di Cristina BenfratelliPalermo, ItalyTaking people
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Azienda Sanitaria Locale TO3Rivoli, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- San Camillo Forlanini HospitalRome, ItalyTaking people
- Azienda Sociosanitaria Ligure 2Savona, ItalyTaking people
- Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Dei Sette LaghiVarese, ItalyTaking 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.