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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Phase 311 800 participants recherchés1 143 sites51 pays

Catégories

Cardiovasculaire83%Endocrinien et métabolique17%

Enregistré dans 1 registre

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Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Diabetes Mellitus, Type 2
  • Hypertension
  • Cardiovascular Diseases

Éligibilité

SexeTous
Âges18 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuQUADRUPLE (4)
Recrutement11 800 participants recherchés

Promoteur et collaborateurs

  • Boehringer Ingelheim Promoteur

Groupes et interventions

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

Interventions

  • Médicament Empagliflozin

    Empagliflozin

  • Médicament Placebo matching Vicadrostat

    Placebo matching Vicadrostat

  • Médicament Vicadrostat

    Vicadrostat

Critères de jugement

  1. Critère de jugement principal

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

    Délai Up to 51 months

  2. Critère de jugement secondaire

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

    Délai Up to 51 months

  3. Critère de jugement secondaire

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

    Délai At baseline and week 24

  4. Critère de jugement secondaire

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

    Délai At baseline and week 24

  5. Critère de jugement secondaire

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

    Délai Up to 51 months

  6. Critère de jugement secondaire

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

    Délai Up to 51 months

  7. Critère de jugement secondaire

    Occurrences of all-cause hospitalisations (first and recurrent)

    Délai Up to 51 months

  8. Critère de jugement secondaire

    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

    Délai Up to 51 months

  9. Critère de jugement secondaire

    Time to all-cause death

    Délai Up to 51 months

  10. Critère de jugement secondaire

    Time to CV death

    Délai Up to 51 months

  11. Critère de jugement secondaire

    Time to first HHF

    Délai Up to 51 months

  12. Critère de jugement secondaire

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

    Délai Up to 51 months

  13. Critère de jugement secondaire

    Occurrences of HHF (first and recurrent)

    Délai Up to 51 months

  14. Critère de jugement secondaire

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

    Délai At baseline and week 24

Dates

Date de début22 juillet 2025 (réelle)
Achèvement principal14 décembre 2029 (estimée)
Achèvement21 décembre 2029 (estimée)
Première publication14 juillet 2025 (réelle)
Dernière mise à jour16 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisseptembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

1 094 sites sont en recrutement

Argentina

ÉtablissementVilleÉtat ou régionStatut
CEC- Centro de Especialidades CardiovascularesBahía BlancaEn recrutement
Buenos Aires Macula S.A.Buenos AiresEn recrutement
IDIM - Instituto de Diagnostico e Investigaciones MetabolicasBuenos AiresEn recrutement
Centro Medico FleischerCABAEn recrutement
CEDIC - Centro de Investigacion ClinicaCABAEn recrutement
Mautalen- Salud e InvestigacionCABAEn recrutement
Equipo CienciaCABAEn recrutement
STAT ResearchCABAEn recrutement
Sanatorio AnchorenaCABAEn recrutement
CPSIC SRL - Cardiologia PalermoCABAEn recrutement
Instituto Cardiovascular de Buenos AiresCiudad Autonoma Buenos AiresEn recrutement
Centro Medico ViamonteCiudad Autonoma de Bs AsEn recrutement
Consultorio de Investigacion Clinica EMO SRLCiudad Autonoma de Buenos AireEn recrutement
Centro Diabetologico Dr WaitmanCórdobaEn recrutement
Clinica Universitaria Reina Fabiola - Universidad Catolica de CordobaCórdobaEn recrutement
Cemaic (Centro de Especialidades Medicas Ambulatorias E Investigacion Clinica)CórdobaEn recrutement
Instituto Privado de Investigaciones Clinica Cordoba S.A.CórdobaEn recrutement
CIPADI - Centro Integral de Prevencion y Atencion en DiabetesGodoy CruzEn recrutement
Centro de Investigaciones Clinicas BaigorriaGranadero BaigorriaEn recrutement
Instituto de Investigaciones Clinicas Mar del PlataMar del PlataEn recrutement
Hospital Privado - Centro Medico de Cordoba S.A.Parque Velez SarsfieldEn recrutement
Instituto Medico Catamarca - IMECRosarioEn recrutement
Instituto Medico Rio CuartoRío CuartoEn recrutement
Centro de Investigaciones Clinicas del LitoralSanta FeEn recrutement
CEDIR Santa FeSanta FeEn recrutement
CEMEDIC - Centro de Especialidades MedicasVilla LuroEn recrutement

Australia

ÉtablissementVilleÉtat ou régionStatut
Nightingale Research Pty LtdAdelaideSouth AustraliaEn recrutement
Flinders Medical CentreBedford ParkSouth AustraliaEn recrutement
Blacktown HospitalBlactownNew South WalesEn recrutement
Advara Heartcare Research BurwoodBurwoodNew South WalesEn recrutement
Royal Prince Alfred HospitalCamperdownNew South WalesEn recrutement
Heart of AustraliaChelmerQueenslandEn recrutement
Prince Charles HospitalChermsideQueenslandEn recrutement
Monash HealthClaytonVictoriaEn recrutement
Concord Repatriation General HospitalConcordNew South WalesEn recrutement
The Northern HospitalEppingVictoriaEn recrutement
Nightingale Research VictoriaFrankstonVictoriaEn recrutement
Canberra HospitalGarranAustralian Capital TerritoryEn recrutement
Royal Brisbane and Women's HospitalHerstonQueenslandTerminé
Royal Hobart HospitalHobartTasmaniaEn recrutement
HeartwestHoppers CrossingVictoriaEn recrutement
Life Clinical ResearchIpswichQueenslandEn recrutement
Advara Heartcare Research WAJoondalupWestern AustraliaEn recrutement
Advara Heart Care-Leabrook-69072LeabrookSouth AustraliaEn recrutement
Sydney Cardiometabolic CentreLiverpoolNew South WalesEn recrutement
Cabrini HealthMalvernVictoriaEn recrutement
Advara HeartCare - MulgraveMulgraveVictoriaEn recrutement
Fiona Stanley HospitalMurdochWestern AustraliaEn recrutement
John Hunter HospitalNew Lambton HeightsNew South WalesEn recrutement
Gold Coast University HospitalSouthportQueenslandEn recrutement

1 093 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 16 septembre 2026

    Site retiré

    4 sites removed (1143 total)

    11471143

  2. 20 août 2026

    Site retiré

    2 sites removed (1147 total)

    11491147

  3. 27 juillet 2026

    Site retiré

    5 sites removed (1149 total)

    11541149

Registre: ClinicalTrials.gov · NCT########

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