Comparing Vicadrostat with Empagliflozin for type 2 diabetes mellitus
Official title: 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
Interventions
Vicadrostat
Vicadrostat
Empagliflozin
Empagliflozin
Placebo matching Vicadrostat
Placebo matching Vicadrostat
Canadian Sites (34)
Diex Recherche (Quebec)
Québec, Canada
CaRe Clinic (Calgary)
Calgary, Alberta, Canada
CARe Clinic (Red Deer)
Red Deer, Alberta, Canada
Medical Arts Research (Kelowna)
Kelowna, British Columbia, Canada
Fraser Clinical Trials
New Westminster, British Columbia, Canada
Medical Arts Research (North Vancouver)
North Vancouver, British Columbia, Canada
Medical Arts Research (Penticton)
Penticton, British Columbia, Canada
SMH Cardiology Clinical Trials Inc.
Surrey, British Columbia, Canada
GA Research Associates Ltd.
Moncton, New Brunswick, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Saul Vizel Medicine Professional Corporation
Cambridge, Ontario, Canada
Medical Trust Clinics
Courtice, Ontario, Canada
Centre for Studies in Family Medicine, Western University (LHRI)
London, Ontario, Canada
KMH Cardiology Centres (Mississauga)
Mississauga, Ontario, Canada
PACE (Partners in Advanced Cardiac Evaluation)
Newmarket, Ontario, Canada
James Cha, MD
Oshawa, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, Canada
CardioQuest Research Centre
Sarnia, Ontario, Canada
Heart Health Institute (Scarborough)
Scarborough Village, Ontario, Canada
KMH Cardiology Centers (Hamilton)
Stoney Creek, Ontario, Canada
Stouffville Medical Research Institute Inc.
Stouffville, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
Diabetes Heart Research Centre
Toronto, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Diex Recherche (Joliette)
Joliette, Quebec, Canada
THEO Medical - Concorde (Laval)
Laval, Quebec, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Endocrinologie Oasis Inc
Montreal, Quebec, Canada
ViaCar Recherches Cliniques Inc. (St-Lambert)
Saint-Lambert, Quebec, Canada
Diex Recherche (Sherbrooke Est)
Sherbrooke, Quebec, Canada
Centre de Medecine Metabolique de Lanaudiere
Terrebonne, Quebec, Canada
Diex Recherche (Trois-Rivieres)
Trois-Rivières, Quebec, Canada
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +At least 18 years old at time of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- +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)
- +Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth controlControl groupThe group a new treatment is measured against.Read more → per ICH M3 (R2).
Exclusion
- −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 (screeningScreeningThe checks done before joining, to see whether a study fits.Read more →)
- −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 (randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →), 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 criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Vicadrostat, Empagliflozin, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → matching Vicadrostat.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 11,800 people.
The study is currently expected to finish around December 2029.
The main measurement is taken over: Up to 51 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to first event of cardiovascular (CV) death or heart failure event (HFE) — measured over Up to 51 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07064473 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About VicadrostatDrug
Vicadrostat
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About EmpagliflozinDrug
Empagliflozin
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo matching VicadrostatDrug
Placebo matching Vicadrostat
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 51 months.
The study as a whole is currently expected to finish around 2029-12-21.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 11,800 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 45 locations, including: Québec, Canada; Calgary, Alberta, Canada; Red Deer, Alberta, Canada; Kelowna, British Columbia, Canada; New Westminster, British Columbia, Canada; North Vancouver, British Columbia, Canada, and 39 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (16)
Revival Research Institute, LLC - Dearborn
Dearborn, Michigan, United States
Aa Mrc Llc
Flint, Michigan, United States
Elite Research Center, LLC
Flint, Michigan, United States
Oakland Medical Center
Troy, Michigan, United States
Billings Clinic - Billings
Billings, Montana, United States
Albany Med Health System - Washington Avenue Extension
Albany, New York, United States
Velocity Clinical Research - Binghamton
Binghamton, New York, United States
RCR - Buffalo
Buffalo, New York, United States
NYC Research Inc.
New York, New York, United States
New York Cardiovascular Specialist PC
New York, New York, United States
Northwell Health - Peconic Bay Medical Group at Riverhead
Riverhead, New York, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
Saratoga Clinical Research, LLC
Saratoga Springs, New York, United States
Southgate Medical Group/ Southgate Medical Park
West Seneca, New York, United States
Great Lakes Medical Research
Westfield, New York, United States
Universal Research Group, LLC
Tacoma, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.