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
- Aracaju - SE, Belo Horizonte, Blumenau, Brasília, Campinas, Curitiba, Fortaleza, Goiânia, Joinville, Maceió, Manaus, Natal, Porto Alegre, Ribeirão Preto, Rio de Janeiro, Santa Cecília, São José do Rio Preto, and São Paulo, BrazilSee the 23 sites
- Phase
- Phase 3
Where in Brazil
- Centro de Pesquisa Clínica do CoraçãoAracaju - SE, BrazilTaking people
- Centro de Pesquisa do Hospital Evangelico de Belo HorizonteBelo Horizonte, BrazilTaking people
- AngioKormann BlumenauBlumenau, BrazilTaking people
- Centro de Pesquisa Clínica do BrasilBrasília, BrazilTaking people
- Hospital PUC-CampinasCampinas, BrazilTaking people
- I9 Pesquisas Clinicas - Loema Instituto de Pesquisa Clínica e Consultores SS LtdaCampinas, BrazilTaking people
- Núcleo de Pesquisa Clínica do ICBS/PUCPRCuritiba, BrazilTaking people
- Centro de Pesquisas em Diabetes e Doencas MetabolicasFortaleza, BrazilTaking people
- Clínica CENDI Endocrinologia e DiabetesGoiânia, BrazilTaking people
- Centro Multidisciplinar de Ensino Especializado e Pesquisa CMEPJoinville, BrazilTaking people
- CESMAC - Hospital do Coração de AlagoasMaceió, BrazilTaking people
- CPHosp ManausManaus, BrazilTaking people
- Centro de Estudos e Pesquisas em Moléstias Infecciosas - CePCLIN RNNatal, BrazilTaking people
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa Sociedade SimplesPorto Alegre, BrazilTaking people
- Hospital Sao Lucas da PUCRSPorto Alegre, BrazilTaking people
- Clinicor Clínica Cardiológica LTDA/ Cardio Prime - CAPEDRibeirão Preto, BrazilTaking people
- Instituto Brasil de Pesquisa Clinica (IBPClin)Rio de Janeiro, BrazilTaking people
- Ruschel Medicina e Pesquisa ClínicaRio de Janeiro, BrazilTaking people
- Irmandade da Santa Casa de Misericórdia de São Paulo - IPEC - Instituto de Pesquisa ClínicaSanta Cecília, BrazilTaking people
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio PretoSão José do Rio Preto, BrazilTaking people
- CEPIC - Centro Paulista de Investigacao Clinica e ServicosSão Paulo, BrazilTaking people
- CPQuali Pesquisa Clínica LtdaSão Paulo, BrazilTaking people
- INCOR e Hospital das Clínicas da Universidade de São PauloSão Paulo, BrazilTaking 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.