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Phase 3RecruitingInterventionalNCT07064473

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

  • Diabetes Mellitus, Type 2
  • Hypertension
  • Cardiovascular Diseases
I want to take partRefer a patient17 sites in India (1 recruiting) · 1142 worldwide

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Boehringer Ingelheim
Enrolment target
11,800
Started
22 July 2025
Main results due (estimated)
14 December 2029
Study ends (estimated)
21 December 2029
Allocation
Randomized
Design
Parallel
Purpose
Treatment
Masking
Quadruple (participant, care provider, investigator, outcomes assessor)
Sites
1142 · 17 in India
First posted
14 July 2025
Registry updated
30 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied. Healthy volunteers are not accepted.

Age groups: adult, older adult.

These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

What participants receive

  • Experimental

    Vicadrostat + empagliflozin treatment arm

    Drug: Vicadrostat · Drug: Empagliflozin

  • Active comparator

    Vicadrostat-placebo + empagliflozin treatment arm

    Drug: Empagliflozin · Drug: Placebo matching Vicadrostat

Interventions

  • VicadrostatDrug

    Also known as BI 690517

  • EmpagliflozinDrug

  • Placebo matching VicadrostatDrug

What the study measures

Primary outcomes

  1. Time to first event of cardiovascular (CV) death or heart failure event (HFE)

    Time frame: Up to 51 months

Secondary outcomes

  1. Time to first event of cardiovascular (CV) death or hospitalisation for heart failure (HHF)

    Time frame: Up to 51 months

  2. Absolute change from baseline in mean systolic blood pressure (SBP) [mmHg] at Week 24

    Time frame: At baseline and week 24

  3. Relative change from baseline in Urine Albumin Creatinine Ratio (UACR) [mg/g] at Week 24

    Time frame: At baseline and week 24

  4. Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death

    Time frame: Up to 51 months

  5. Time to first event of CV death, HFE, non-fatal myocardial infarction (MI) or non-fatal stroke (4-point Major adverse cardiovascular events (MACE))

    Time frame: Up to 51 months

  6. Occurrences of all-cause hospitalisations (first and recurrent)

    Time frame: Up to 51 months

  7. Time to first event of new-onset atrial fibrillation or atrial flutter (in participants without history of atrial fibrillation and atrial flutter) or CV death

    Time frame: Up to 51 months

  8. Time to all-cause death

    Time frame: Up to 51 months

  9. Time to CV death

    Time frame: Up to 51 months

  10. Time to first HHF

    Time frame: Up to 51 months

  11. Time to first event of new-onset HF or CV death

    Time frame: Up to 51 months

  12. Occurrences of HHF (first and recurrent)

    Time frame: Up to 51 months

  13. Absolute change from baseline in mean diastolic blood pressure (DBP) [mmHg] at Week 24

    Time frame: At baseline and week 24

Who is running it

Lead sponsor
Boehringer Ingelheim
Sponsor type
Industry
Responsible party
The sponsor
Organisation
Boehringer Ingelheim
Data monitoring committee
Yes
US FDA-regulated drug
Yes
US FDA-regulated device
No
Sponsor's study ID
1378-0041
Other IDs
U1111-1319-9064, 2025-521188-11-00, 2025

Study sites(1142)

Showing 40 of 1142 sites, filter to narrow it down. 1095 of 1142 on this study are recruiting right now, and 17 are in India. A site can stop enrolling while the study as a whole is still open.

References and data sharing

Participant data shared
Yes
When
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Access
For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Source: ClinicalTrials.gov record NCT07064473, status verified September 2026. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 | Trialion