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
- Besancon Cedex, Boulogne-Billancourt, Brest, Bron, Caen Cedex 9, Chalon Sur Saone Cedex, Chambéry, Chambray Les Tours, Corbeil-Essonnes, Évecquemont, Grenoble, Grenoble Cedex 9, Haguenau, Jossigny, La Rochelle, Le Chesnay Rocquencourt, Le Coudray, Lille, Lyon, Marseille, Meaux, Metz Cedex 03, Montpellier, Nice, Paris, Paris Cedex 18, Pau, Pessac Cedex, Poitiers, Quimper Cedex, Reims Cedex, Saint-Brieuc, Saint-Herblain, Strasbourg, Toulouse Cedex 9, Troyes, Vandoeuvre Les Nancy, and Vénissieux, FranceSee the 40 sites
- Phase
- Phase 3
Where in France
- CHU BesanconBesancon Cedex, FranceTaking people
- Assistance Publique Hopitaux De ParisBoulogne-Billancourt, FranceTaking people
- Centre Hospitalier Régional et Universitaire de BrestBrest, FranceTaking people
- Hospices Civils de LyonBron, FranceTaking people
- Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9, FranceTaking people
- Centre Hospitalier William MoreyChalon Sur Saone Cedex, FranceTaking people
- Centre Hospitalier Métropole SavoieChambéry, FranceTaking people
- Centre Hospitalier Regional Universitaire De ToursChambray Les Tours, FranceTaking people
- Centre Hospitalier Sud FrancilienCorbeil-Essonnes, FranceTaking people
- Centre Cardiologique d'EvecquemontÉvecquemont, FranceTaking people
- Union Mut Gestion Groupe Hosp Mutualiste De GrenobleGrenoble, FranceTaking people
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranceTaking people
- Centre Hospitalier de HaguenauHaguenau, FranceTaking people
- Grand Hopital De L Est FrancilienJossigny, FranceTaking people
- Centre Hospitalier Groupe Hospitalier De La Rochelle Re AunisLa Rochelle, FranceTaking people
- Centre Hospitalier De VersaillesLe Chesnay Rocquencourt, FranceTaking people
- Les Hopitaux De ChartresLe Coudray, FranceTaking people
- Centre Hospitalier Universitaire de LilleLille, FranceTaking people
- Centre Hospitalier Saint Joseph Saint LucLyon, FranceTaking people
- Centre Hospitalier Regional De MarseilleMarseille, FranceTaking people
- Hôpital Saint JosephMarseille, FranceTaking people
- Grand Hopital de l'Est FrancilienMeaux, FranceTaking people
- Centre Hospital Region Metz ThionvilleMetz Cedex 03, FranceTaking people
- Centre Hospitalier Universitaire de MontpellierMontpellier, FranceTaking people
- Clinique du MillenaireMontpellier, FranceTaking people
- Centre Hospitalier Universitaire de NiceNice, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 18, FranceTaking people
- Centre Hospitalier de PauPau, FranceTaking people
- Centre Hospitalier Universitaire De BordeauxPessac Cedex, FranceTaking people
- Centre Hospitalier Universitaire de PoitiersPoitiers, FranceTaking people
- Centre Hospitalier Intercommunal De CornouailleQuimper Cedex, FranceTaking people
- Centre Hospitalier Universitaire ReimsReims Cedex, FranceTaking people
- Centre Hospitalier De Saint-BrieucSaint-Brieuc, FranceTaking people
- Centre Hospitalier Universitaire de NantesSaint-Herblain, FranceTaking people
- Les Hopitaux Universitaires de StrasbourgStrasbourg, FranceTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceTaking people
- Centre Hospitalier de TroyesTroyes, FranceTaking people
- CHRU De NancyVandoeuvre Les Nancy, FranceTaking people
- Centre de Recherche Clinique Portes Du SudVénissieux, FranceTaking 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.