NCT07064473ClinicalTrials.gov

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

RecruitingTaking participants now, according to the registry record.

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In brief

Phase 311,800 participants sought1,143 sites51 countries

Registered in 1 registry

ClinicalTrials.govNCT07064473Open this record at ClinicalTrials.govSynced 5 days ago

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2025-07-14; recorded start 2025-07-22
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1218 other studies in this databaseCounted from the lead sponsor named in the record (Boehringer Ingelheim)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 3 conditions.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 1154 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEGA

A very large study, international in scope: 11,800 participants (target), run at 1,143 sites, across 51 countries.

How this score is built

Enrolment38/40
11,800 participants (target)
Site count25/25
1,154 sites
Country count15/15
51 countries
Planned duration9/10
Planned over about 54 months
Sponsor scale10/10
Boehringer Ingelheim has led 1,211 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

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.

Conditions

Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	QUADRUPLE (4)
Enrolment	11,800 participants sought

Sponsor and collaborators

Boehringer Ingelheim Sponsor

Arms and interventions

Vicadrostat + empagliflozin treatment armEXPERIMENTAL
Vicadrostat-placebo + empagliflozin treatment armACTIVE_COMPARATOR

Interventions

Drug Empagliflozin
Empagliflozin
Drug Placebo matching Vicadrostat
Placebo matching Vicadrostat
Drug Vicadrostat
Vicadrostat

Outcome measures

Primary outcome
Time to first event of cardiovascular (CV) death or heart failure event (HFE)
Time frame Up to 51 months
Secondary outcome
Time to first event of cardiovascular (CV) death or hospitalisation for heart failure (HHF)
Time frame Up to 51 months
Secondary outcome
Absolute change from baseline in mean systolic blood pressure (SBP) [mmHg] at Week 24
Time frame At baseline and week 24
Secondary outcome
Relative change from baseline in Urine Albumin Creatinine Ratio (UACR) [mg/g] at Week 24
Time frame At baseline and week 24
Secondary outcome
Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death
Time frame Up to 51 months
Secondary outcome
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
Secondary outcome
Occurrences of all-cause hospitalisations (first and recurrent)
Time frame Up to 51 months
Secondary outcome
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
Secondary outcome
Time to all-cause death
Time frame Up to 51 months
Secondary outcome
Time to CV death
Time frame Up to 51 months
Secondary outcome
Time to first HHF
Time frame Up to 51 months
Secondary outcome
Time to first event of new-onset HF or CV death
Time frame Up to 51 months
Secondary outcome
Occurrences of HHF (first and recurrent)
Time frame Up to 51 months
Secondary outcome
Absolute change from baseline in mean diastolic blood pressure (DBP) [mmHg] at Week 24
Time frame At baseline and week 24

Dates

Dates
Start date	July 22, 2025 (actual)
Primary completion	December 14, 2029 (estimated)
Completion	December 21, 2029 (estimated)
First posted	July 14, 2025 (actual)
Last updated	September 16, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

1,094 sites are recruiting

Argentina

Argentina
Facility	City	Status
CEC- Centro de Especialidades Cardiovasculares	Bahía Blanca	Recruiting
Buenos Aires Macula S.A.	Buenos Aires	Recruiting
IDIM - Instituto de Diagnostico e Investigaciones Metabolicas	Buenos Aires	Recruiting
Centro Medico Fleischer	CABA	Recruiting
CEDIC - Centro de Investigacion Clinica	CABA	Recruiting
Mautalen- Salud e Investigacion	CABA	Recruiting
Equipo Ciencia	CABA	Recruiting
STAT Research	CABA	Recruiting
Sanatorio Anchorena	CABA	Recruiting
CPSIC SRL - Cardiologia Palermo	CABA	Recruiting
Instituto Cardiovascular de Buenos Aires	Ciudad Autonoma Buenos Aires	Recruiting
Centro Medico Viamonte	Ciudad Autonoma de Bs As	Recruiting
Consultorio de Investigacion Clinica EMO SRL	Ciudad Autonoma de Buenos Aire	Recruiting
Centro Diabetologico Dr Waitman	Córdoba	Recruiting
Clinica Universitaria Reina Fabiola - Universidad Catolica de Cordoba	Córdoba	Recruiting
Cemaic (Centro de Especialidades Medicas Ambulatorias E Investigacion Clinica)	Córdoba	Recruiting
Instituto Privado de Investigaciones Clinica Cordoba S.A.	Córdoba	Recruiting
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes	Godoy Cruz	Recruiting
Centro de Investigaciones Clinicas Baigorria	Granadero Baigorria	Recruiting
Instituto de Investigaciones Clinicas Mar del Plata	Mar del Plata	Recruiting
Hospital Privado - Centro Medico de Cordoba S.A.	Parque Velez Sarsfield	Recruiting
Instituto Medico Catamarca - IMEC	Rosario	Recruiting
Instituto Medico Rio Cuarto	Río Cuarto	Recruiting
Centro de Investigaciones Clinicas del Litoral	Santa Fe	Recruiting
CEDIR Santa Fe	Santa Fe	Recruiting
CEMEDIC - Centro de Especialidades Medicas	Villa Luro	Recruiting

Australia

Australia
Facility	City	State or region	Status
Nightingale Research Pty Ltd	Adelaide	South Australia	Recruiting
Flinders Medical Centre	Bedford Park	South Australia	Recruiting
Blacktown Hospital	Blactown	New South Wales	Recruiting
Advara Heartcare Research Burwood	Burwood	New South Wales	Recruiting
Royal Prince Alfred Hospital	Camperdown	New South Wales	Recruiting
Heart of Australia	Chelmer	Queensland	Recruiting
Prince Charles Hospital	Chermside	Queensland	Recruiting
Monash Health	Clayton	Victoria	Recruiting
Concord Repatriation General Hospital	Concord	New South Wales	Recruiting
The Northern Hospital	Epping	Victoria	Recruiting
Nightingale Research Victoria	Frankston	Victoria	Recruiting
Canberra Hospital	Garran	Australian Capital Territory	Recruiting
Royal Brisbane and Women's Hospital	Herston	Queensland	Completed
Royal Hobart Hospital	Hobart	Tasmania	Recruiting
Heartwest	Hoppers Crossing	Victoria	Recruiting
Life Clinical Research	Ipswich	Queensland	Recruiting
Advara Heartcare Research WA	Joondalup	Western Australia	Recruiting
Advara Heart Care-Leabrook-69072	Leabrook	South Australia	Recruiting
Sydney Cardiometabolic Centre	Liverpool	New South Wales	Recruiting
Cabrini Health	Malvern	Victoria	Recruiting
Advara HeartCare - Mulgrave	Mulgrave	Victoria	Recruiting
Fiona Stanley Hospital	Murdoch	Western Australia	Recruiting
John Hunter Hospital	New Lambton Heights	New South Wales	Recruiting
Gold Coast University Hospital	Southport	Queensland	Recruiting

1,093 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 16, 2026
Site removed
4 sites removed (1143 total)
11471143
August 20, 2026
Site removed
2 sites removed (1147 total)
11491147
July 27, 2026
Site removed
5 sites removed (1149 total)
11541149

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07064473

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Argentina

Australia

Study documents

Changes over time