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

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.

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Kurz gefasst

Phase 311.800 Teilnehmende gesucht1.143 Studienzentren51 Länder

Kategorien

Herz-Kreislauf83%Endokrin und metabolisch17%

In 1 Register registriert

ClinicalTrials.govNCT07064473Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 5 Tagen

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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.

Zusammenfassung

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.

Erkrankungen

Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	QUADRUPLE (4)
Teilnahme	11.800 Teilnehmende gesucht

Sponsor und Mitwirkende

Boehringer Ingelheim Sponsor

Studienarme und Interventionen

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

Interventionen

Arzneimittel Empagliflozin
Empagliflozin
Arzneimittel Placebo matching Vicadrostat
Placebo matching Vicadrostat
Arzneimittel Vicadrostat
Vicadrostat

Endpunkte

Primärer Endpunkt
Time to first event of cardiovascular (CV) death or heart failure event (HFE)
Zeitrahmen Up to 51 months
Sekundärer Endpunkt
Time to first event of cardiovascular (CV) death or hospitalisation for heart failure (HHF)
Zeitrahmen Up to 51 months
Sekundärer Endpunkt
Absolute change from baseline in mean systolic blood pressure (SBP) [mmHg] at Week 24
Zeitrahmen At baseline and week 24
Sekundärer Endpunkt
Relative change from baseline in Urine Albumin Creatinine Ratio (UACR) [mg/g] at Week 24
Zeitrahmen At baseline and week 24
Sekundärer Endpunkt
Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death
Zeitrahmen Up to 51 months
Sekundärer Endpunkt
Time to first event of CV death, HFE, non-fatal myocardial infarction (MI) or non-fatal stroke (4-point Major adverse cardiovascular events (MACE))
Zeitrahmen Up to 51 months
Sekundärer Endpunkt
Occurrences of all-cause hospitalisations (first and recurrent)
Zeitrahmen Up to 51 months
Sekundärer Endpunkt
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
Zeitrahmen Up to 51 months
Sekundärer Endpunkt
Time to all-cause death
Zeitrahmen Up to 51 months
Sekundärer Endpunkt
Time to CV death
Zeitrahmen Up to 51 months
Sekundärer Endpunkt
Time to first HHF
Zeitrahmen Up to 51 months
Sekundärer Endpunkt
Time to first event of new-onset HF or CV death
Zeitrahmen Up to 51 months
Sekundärer Endpunkt
Occurrences of HHF (first and recurrent)
Zeitrahmen Up to 51 months
Sekundärer Endpunkt
Absolute change from baseline in mean diastolic blood pressure (DBP) [mmHg] at Week 24
Zeitrahmen At baseline and week 24

Daten

Daten
Startdatum	22. Juli 2025 (tatsächlich)
Primärer Abschluss	14. Dezember 2029 (geschätzt)
Abschluss	21. Dezember 2029 (geschätzt)
Erstveröffentlichung	14. Juli 2025 (tatsächlich)
Zuletzt aktualisiert	16. September 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	September 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

1.094 Studienzentren rekrutieren

Argentina

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

Australia

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

1.093 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

16. September 2026
Studienzentrum entfernt
4 sites removed (1143 total)
11471143
20. August 2026
Studienzentrum entfernt
2 sites removed (1147 total)
11491147
27. Juli 2026
Studienzentrum entfernt
5 sites removed (1149 total)
11541149

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