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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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…

Fase 311.800 partecipanti ricercati1143 centri51 paesi

Categorie

Cardiovascolare83%Endocrino e metabolico17%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

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

Sintesi

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.

Patologie

  • Diabetes Mellitus, Type 2
  • Hypertension
  • Cardiovascular Diseases

Idoneità

SessoTutti
Età18 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel registro

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.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoQUADRUPLE (4)
Arruolamento11.800 partecipanti ricercati

Sponsor e collaboratori

  • Boehringer Ingelheim Sponsor

Bracci e interventi

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

Interventi

  • Farmaco Empagliflozin

    Empagliflozin

  • Farmaco Placebo matching Vicadrostat

    Placebo matching Vicadrostat

  • Farmaco Vicadrostat

    Vicadrostat

Esiti misurati

  1. Esito primario

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

    Orizzonte temporale Up to 51 months

  2. Esito secondario

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

    Orizzonte temporale Up to 51 months

  3. Esito secondario

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

    Orizzonte temporale At baseline and week 24

  4. Esito secondario

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

    Orizzonte temporale At baseline and week 24

  5. Esito secondario

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

    Orizzonte temporale Up to 51 months

  6. Esito secondario

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

    Orizzonte temporale Up to 51 months

  7. Esito secondario

    Occurrences of all-cause hospitalisations (first and recurrent)

    Orizzonte temporale Up to 51 months

  8. Esito secondario

    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

    Orizzonte temporale Up to 51 months

  9. Esito secondario

    Time to all-cause death

    Orizzonte temporale Up to 51 months

  10. Esito secondario

    Time to CV death

    Orizzonte temporale Up to 51 months

  11. Esito secondario

    Time to first HHF

    Orizzonte temporale Up to 51 months

  12. Esito secondario

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

    Orizzonte temporale Up to 51 months

  13. Esito secondario

    Occurrences of HHF (first and recurrent)

    Orizzonte temporale Up to 51 months

  14. Esito secondario

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

    Orizzonte temporale At baseline and week 24

Date

Data di inizio22 luglio 2025 (effettiva)
Conclusione primaria14 dicembre 2029 (stimata)
Conclusione21 dicembre 2029 (stimata)
Prima pubblicazione14 luglio 2025 (effettiva)
Ultimo aggiornamento16 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

1094 centri stanno reclutando

Argentina

StrutturaCittàStato o regioneStato
CEC- Centro de Especialidades CardiovascularesBahía BlancaIn reclutamento
Buenos Aires Macula S.A.Buenos AiresIn reclutamento
IDIM - Instituto de Diagnostico e Investigaciones MetabolicasBuenos AiresIn reclutamento
Centro Medico FleischerCABAIn reclutamento
CEDIC - Centro de Investigacion ClinicaCABAIn reclutamento
Mautalen- Salud e InvestigacionCABAIn reclutamento
Equipo CienciaCABAIn reclutamento
STAT ResearchCABAIn reclutamento
Sanatorio AnchorenaCABAIn reclutamento
CPSIC SRL - Cardiologia PalermoCABAIn reclutamento
Instituto Cardiovascular de Buenos AiresCiudad Autonoma Buenos AiresIn reclutamento
Centro Medico ViamonteCiudad Autonoma de Bs AsIn reclutamento
Consultorio de Investigacion Clinica EMO SRLCiudad Autonoma de Buenos AireIn reclutamento
Centro Diabetologico Dr WaitmanCórdobaIn reclutamento
Clinica Universitaria Reina Fabiola - Universidad Catolica de CordobaCórdobaIn reclutamento
Cemaic (Centro de Especialidades Medicas Ambulatorias E Investigacion Clinica)CórdobaIn reclutamento
Instituto Privado de Investigaciones Clinica Cordoba S.A.CórdobaIn reclutamento
CIPADI - Centro Integral de Prevencion y Atencion en DiabetesGodoy CruzIn reclutamento
Centro de Investigaciones Clinicas BaigorriaGranadero BaigorriaIn reclutamento
Instituto de Investigaciones Clinicas Mar del PlataMar del PlataIn reclutamento
Hospital Privado - Centro Medico de Cordoba S.A.Parque Velez SarsfieldIn reclutamento
Instituto Medico Catamarca - IMECRosarioIn reclutamento
Instituto Medico Rio CuartoRío CuartoIn reclutamento
Centro de Investigaciones Clinicas del LitoralSanta FeIn reclutamento
CEDIR Santa FeSanta FeIn reclutamento
CEMEDIC - Centro de Especialidades MedicasVilla LuroIn reclutamento

Australia

StrutturaCittàStato o regioneStato
Nightingale Research Pty LtdAdelaideSouth AustraliaIn reclutamento
Flinders Medical CentreBedford ParkSouth AustraliaIn reclutamento
Blacktown HospitalBlactownNew South WalesIn reclutamento
Advara Heartcare Research BurwoodBurwoodNew South WalesIn reclutamento
Royal Prince Alfred HospitalCamperdownNew South WalesIn reclutamento
Heart of AustraliaChelmerQueenslandIn reclutamento
Prince Charles HospitalChermsideQueenslandIn reclutamento
Monash HealthClaytonVictoriaIn reclutamento
Concord Repatriation General HospitalConcordNew South WalesIn reclutamento
The Northern HospitalEppingVictoriaIn reclutamento
Nightingale Research VictoriaFrankstonVictoriaIn reclutamento
Canberra HospitalGarranAustralian Capital TerritoryIn reclutamento
Royal Brisbane and Women's HospitalHerstonQueenslandCompletato
Royal Hobart HospitalHobartTasmaniaIn reclutamento
HeartwestHoppers CrossingVictoriaIn reclutamento
Life Clinical ResearchIpswichQueenslandIn reclutamento
Advara Heartcare Research WAJoondalupWestern AustraliaIn reclutamento
Advara Heart Care-Leabrook-69072LeabrookSouth AustraliaIn reclutamento
Sydney Cardiometabolic CentreLiverpoolNew South WalesIn reclutamento
Cabrini HealthMalvernVictoriaIn reclutamento
Advara HeartCare - MulgraveMulgraveVictoriaIn reclutamento
Fiona Stanley HospitalMurdochWestern AustraliaIn reclutamento
John Hunter HospitalNew Lambton HeightsNew South WalesIn reclutamento
Gold Coast University HospitalSouthportQueenslandIn reclutamento

Nella scheda del registro sono indicati altri 1093 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 16 settembre 2026

    Centro rimosso

    4 sites removed (1143 total)

    11471143

  2. 20 agosto 2026

    Centro rimosso

    2 sites removed (1147 total)

    11491147

  3. 27 luglio 2026

    Centro rimosso

    5 sites removed (1149 total)

    11541149

Registro: ClinicalTrials.gov · NCT########

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