Taking people in United StatesPhase 3
Tests vicadrostat with empagliflozin in adults with type 2 diabetes and heart disease
Tests vicadrostat taken with empagliflozin in adults with diabetes, high blood pressure and heart disease.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Albany, Albuquerque, Anniston, Aurora, Austin, Avon, Baltimore, Beaver, Beverly Hills, Billings, Binghamton, Boca Raton, Bossier City, Bowling Green, Bridgeport, Bridgewater, Brownsville, Buffalo, Camp Hill, Canoga Park, Cary, Chandler, Chapel Hill, Chicago, Cincinnati, Clearwater, Columbus, Concord, Covington, Cutler Bay, Dakota Dunes, Dallas, Dearborn, DeLand, Doral, El Dorado, El Paso, Elkhart, Fairhope, Falls Church, Fargo, Fayette, Fleming Island, Flint, Forney, Fort Mill, Fort Myers, Fort Worth, Franklin, Fremont, Gaffney, Golden, Greenfield, Greenville, Guntersville, Hallandale, Hamden, Honolulu, Houston, Huntington Park, Idaho Falls, Jacksonville, Jefferson City, Johns Creek, Kansas City, Kenosha, Kissimmee, Knoxville, La Mesa, Lake City, Lakeland, Lancaster, Las Vegas, Lenoir, Lewisville, Lexington, Linden, Lombard, Long Beach, Macon, Malden, Manassas, Marietta, Mesquite, Methuen, Miami, Miami Lakes, Monroe, Mooresville, Morehead City, Morgantown, Muncie, Naples, New Port Richey, New York, Norfolk, North Las Vegas, Oak Lawn, Oklahoma City, Olney, Omaha, Orange, Orlando, Ormond Beach, Owensboro, Oxon Hill, Palm Beach Gardens, Palmetto Bay, Pembroke Pines, Philadelphia, Phoenix, Pittsburgh, Pomona, Port Charlotte, Richmond, Riverhead, Riverview, Rochester, Saint Augustine, Salisbury, Salt Lake City, San Antonio, San Bernardino, San Diego, San Marcos, Santa Rosa, Saratoga Springs, Savannah, Scottdale, Shavano Park, Sherman, Shreveport, Slidell, Smithfield, Somerset, St Louis, St. Petersburg, Stamford, Stephenville, Sun City West, Tacoma, Tempe, Thomasville, Tomball, Topeka, Torrance, Troy, Tucker, Tucson, Union, Uniontown, University Park, Vista, Waco, Wausau, Wauwatosa, Wellington, Weslaco, West Chester, West Jordan, West Monroe, West Seneca, Westfield, Westlake, Wichita, Wilmington, Winchester, Winston-Salem, Yardley, Yuma, and Zachary, United StatesSee the 207 sites
- Phase
- Phase 3
Where in United States
- Albany Med Health System - Washington Avenue ExtensionAlbany, United StatesTaking people
- IMA Clinical Research - AlbuquerqueAlbuquerque, United StatesTaking people
- New Mexico Clinical Research and Osteoporosis Center, Inc.Albuquerque, United StatesTaking people
- Pinnacle Research Group, LLCAnniston, United StatesTaking people
- Rocky Mountain Regional VA Medical CenterAurora, United StatesTaking people
- Pinnacle Clinical Research - AustinAustin, United StatesTaking people
- American Health Network - AvonAvon, United StatesTaking people
- Ascension Saint Agnes Heart CareBaltimore, United StatesTaking people
- Heritage Valley Medical GroupBeaver, United StatesTaking people
- National Heart InstituteBeverly Hills, United StatesTaking people
- Billings Clinic - BillingsBillings, United StatesTaking people
- Velocity Clinical Research - BinghamtonBinghamton, United StatesTaking people
- Excel Medical Clinical TrialsBoca Raton, United StatesTaking people
- Grace Research, LLC-Bossier City-51040Bossier City, United StatesTaking people
- Qualmedica Research - Bowling GreenBowling Green, United StatesTaking people
- Cardiology Physicians of Fairfield County - BridgeportBridgeport, United StatesTaking people
- Advanced Heart Care LLCBridgewater, United StatesTaking people
- Headlands Research - BrownsvilleBrownsville, United StatesTaking people
- South Texas Research Institute - BrownsvilleBrownsville, United StatesTaking people
- RCR - BuffaloBuffalo, United StatesTaking people
- Capital Area Research, LLCCamp Hill, United StatesTaking people
- Hope Clinical ResearchCanoga Park, United StatesTaking people
- Cary CardiologyCary, United StatesTaking people
- Arizona Clinical Trials - ChandlerChandler, United StatesTaking people
- The University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
- Cedar Crosse Research CenterChicago, United StatesTaking people
- Walgreens - Chicago - Site 162Chicago, United StatesNo longer taking part
- The Christ HospitalCincinnati, United StatesTaking people
- Velocity Clinical Research-Cincinnati-69044Cincinnati, United StatesTaking people
- Clinical Research of West Florida, Inc.Clearwater, United StatesTaking people
- Centricity Research-Columbus-68879Columbus, United StatesTaking people
- Centricity Research, Endocrine ConsultantsColumbus, United StatesTaking people
- Remington-Davis Clinical Research, IncColumbus, United StatesTaking people
- John Muir Physician Network Clinical Research CenterConcord, United StatesTaking people
- Louisiana Heart Center - CovingtonCovington, United StatesTaking people
- Beautiful Minds Clinical Research CenterCutler Bay, United StatesTaking people
- Dunes Clinical ResearchDakota Dunes, United StatesTaking people
- North Texas Endocrine CenterDallas, United StatesTaking people
- Soltero Cardiovascular Research CenterDallas, United StatesTaking people
- Southwest Family Medicine AssociatesDallas, United StatesTaking people
- University of Texas Southwestern Medical CenterDallas, United StatesTaking people
- Revival Research Institute, LLC - DearbornDearborn, United StatesTaking people
- Hillcrest Medical ResearchDeLand, United StatesTaking people
- University Clinical Research Deland, LLCDeLand, United StatesTaking people
- Universal Axon Clinical ResearchDoral, United StatesTaking people
- AMR El DoradoEl Dorado, United StatesTaking people
- Academy Of Diabetes, Thyroid And Endocrine, PAEl Paso, United StatesTaking people
- Midwest Cardiovascular Research and Education FoundationElkhart, United StatesTaking people
- Eastern Shore Research GroupFairhope, United StatesTaking people
- Seven Corners Medical CenterFalls Church, United StatesTaking people
- Lillestol Research, LLCFargo, United StatesTaking people
- Prime Health and WellnessFayette, United StatesTaking people
- Northeast Research InstituteFleming Island, United StatesTaking people
- Aa Mrc LlcFlint, United StatesTaking people
- Elite Research Center, LLCFlint, United StatesTaking people
- Care United ResearchForney, United StatesTaking people
- Piedmont Research Partners LLCFort Mill, United StatesTaking people
- Covenant Metabolic Specialists, LLC - Fort MyersFort Myers, United StatesTaking people
- Diabetes and Thyroid Center of Fort WorthFort Worth, United StatesTaking people
- Javara Inc / Texas Health Care, PLLCFort Worth, United StatesTaking people
- Texas Health Physicians GroupFort Worth, United StatesTaking people
- American Health Network - FranklinFranklin, United StatesNo longer taking part
- Methodist Physicians ClinicFremont, United StatesTaking people
- Velocity Clinical Research-Gaffney-69046Gaffney, United StatesTaking people
- OptumCare Clinical Trials, LLCGolden, United StatesNo longer taking part
- American Health Network - GreenfieldGreenfield, United StatesTaking people
- Physicians East, PAGreenville, United StatesTaking people
- Tribe Clinical Research, LLC- GreenvilleGreenville, United StatesTaking people
- Lakeview Clinical ResearchGuntersville, United StatesTaking people
- Velocity Clinical Research-Hallandale Beach-67888Hallandale, United StatesTaking people
- CMR of Greater New Haven, LLCHamden, United StatesTaking people
- Pacific Diabetes & Endocrine CenterHonolulu, United StatesTaking people
- Houston Research InstituteHouston, United StatesTaking people
- Victorium Clinical ResearchHouston, United StatesTaking people
- Velocity Clinical Research-Huntington ParkHuntington Park, United StatesTaking people
- Rocky Mountain Clinical Research - Idaho FallsIdaho Falls, United StatesTaking people
- East Coast Institute for Research, LLC - SouthsideJacksonville, United StatesTaking people
- Jacksonville Center for Clinical ResearchJacksonville, United StatesTaking people
- Northeast Research InstituteJacksonville, United StatesTaking people
- Westside Center for Clinical ResearchJacksonville, United StatesTaking people
- Jefferson City Medical GroupJefferson City, United StatesTaking people
- NSC Research, IncJohns Creek, United StatesTaking people
- Johnson County ClinTrialsKansas City, United StatesTaking people
- Clinical Investigation Specialists, Inc.-Kenosha-69111Kenosha, United StatesTaking people
- Walgreens - Kissimmee - Site 4442Kissimmee, United StatesNo longer taking part
- Alliance for Multispecialty Research, LLC-Knoxville-69693Knoxville, United StatesTaking people
- Velocity Clinical Research, San DiegoLa Mesa, United StatesTaking people
- East Coast Institute for Research - Lake CityLake City, United StatesTaking people
- Clinical Research of Central Florida - LakelandLakeland, United StatesTaking people
- First Valley Medical GroupLancaster, United StatesTaking people
- AB Clinical TrialsLas Vegas, United StatesTaking people
- Las Vegas Clinical TrialsLas Vegas, United StatesTaking people
- Palm Research CenterLas Vegas, United StatesTaking people
- Vector Clinical Trials - Las VegasLas Vegas, United StatesTaking people
- IMA Clinical Research - LenoirLenoir, United StatesTaking people
- Epic Clinical ResearchLewisville, United StatesTaking people
- The Research Group of LexingtonLexington, United StatesTaking people
- NJ Heart LLCLinden, United StatesTaking people
- Accellacare of Duly - LombardLombard, United StatesTaking people
- Ark Clinical ResearchLong Beach, United StatesTaking people
- The Jones Center Clinical Research, LLCMacon, United StatesTaking people
- Walgreens - Malden - Site 4966Malden, United StatesNo longer taking part
- Carient Heart and VascularManassas, United StatesTaking people
- Urban Family Practice Associates, PCMarietta, United StatesTaking people
- Southern Endocrinology AssociatesMesquite, United StatesTaking people
- ActivMed Practices & ResearchMethuen, United StatesTaking people
- Alma Clinical Research, Inc.Miami, United StatesTaking people
- Finlay Medical Research CorpMiami, United StatesTaking people
- IMIC, Inc.Miami, United StatesTaking people
- Oceane7 Clinical ResearchMiami, United StatesTaking people
- Optimus U Corporation-Miami-69452Miami, United StatesTaking people
- Research Institute of South Florida, Inc.Miami, United StatesTaking people
- Indago Research and Health CenterMiami Lakes, United StatesTaking people
- IMA Clinical Research MonroeMonroe, United StatesTaking people
- Accellacare-Mooresville-69123Mooresville, United StatesTaking people
- Lucas Research, Inc.Morehead City, United StatesTaking people
- Frontier Clinical Research, LLC - MorgantownMorgantown, United StatesTaking people
- American Health Network - MuncieMuncie, United StatesTaking people
- Advanced Research for Health Improvement LLCNaples, United StatesTaking people
- Suncoast Clinical ResearchNew Port Richey, United StatesTaking people
- New York Cardiovascular Specialist PCNew York, United StatesTaking people
- NYC Research Inc.New York, United StatesTaking people
- York Clinical ResearchNorfolk, United StatesTaking people
- Walgreens - North Las Vegas - Site 5814North Las Vegas, United StatesNo longer taking part
- Accellacare of DulyOak Lawn, United StatesTaking people
- South Oklahoma Heart Research GroupOklahoma City, United StatesTaking people
- Tekton Research Oklahoma CityOklahoma City, United StatesTaking people
- Medstar Montgomery Medical CenterOlney, United StatesTaking people
- Quality Clinical Research - OmahaOmaha, United StatesTaking people
- Diabetes Associates Medical GroupOrange, United StatesTaking people
- Florida Institute for Clinical ResearchOrlando, United StatesTaking people
- Ormond Beach Clinical ResearchOrmond Beach, United StatesTaking people
- Research Integrity LLCOwensboro, United StatesTaking people
- MD Medical ResearchOxon Hill, United StatesTaking people
- Cardiology Partners Clinical Research InstitutePalm Beach Gardens, United StatesTaking people
- Innovation Medical Research CenterPalmetto Bay, United StatesTaking people
- Center for Diabetes, Obesity and MetabolismPembroke Pines, United StatesTaking people
- Thomas Jefferson UniversityPhiladelphia, United StatesTaking people
- Tristar Clinical Investigations PCPhiladelphia, United StatesTaking people
- Elite Clinical StudiesPhoenix, United StatesTaking people
- Preferred Primary Care Physicians-Pittsburgh-63932Pittsburgh, United StatesTaking people
- Preferred Primary Care Physicians, Inc.Pittsburgh, United StatesTaking people
- Empire Clinical ResearchPomona, United StatesTaking people
- Peace River Cardiovascular CenterPort Charlotte, United StatesTaking people
- Dominion Medical Associates - DowntownRichmond, United StatesTaking people
- Reid Physician AssociatesRichmond, United StatesTaking people
- Northwell Health - Peconic Bay Medical Group at RiverheadRiverhead, United StatesTaking people
- Covenant Metabolic Specialists, LLC - BrandonRiverview, United StatesTaking people
- Rochester Clinical Research, IncRochester, United StatesTaking people
- East Coast Institute for Research, LLC-Saint Augustine-63032Saint Augustine, United StatesTaking people
- TidalHealth, INCSalisbury, United StatesTaking people
- Olympus Family MedicineSalt Lake City, United StatesTaking people
- Endeavor Clinical TrialsSan Antonio, United StatesTaking people
- IMA Clinical Research San AntonioSan Antonio, United StatesTaking people
- Pinnacle Clinical Research, LLCSan Antonio, United StatesTaking people
- Tekton Research-San Antonio-68916San Antonio, United StatesTaking people
- University of Texas Health Science Center at San AntonioSan Antonio, United StatesTaking people
- Velocity Clinical Research, San BernardinoSan Bernardino, United StatesTaking people
- Acclaim Clinical ResearchSan Diego, United StatesTaking people
- Javara Inc. and Privia Medical Group Gulf Coast, PLLCSan Marcos, United StatesTaking people
- NorthBay Clinical Research LLCSanta Rosa, United StatesTaking people
- Saratoga Clinical Research, LLCSaratoga Springs, United StatesTaking people
- Javara-Savannah-67450Savannah, United StatesTaking people
- Frontier Clinical Research LLC - ScottdaleScottdale, United StatesTaking people
- Consano Clinical ResearchShavano Park, United StatesTaking people
- Sherman Clinical ResearchSherman, United StatesTaking people
- Grace Research, LLC-Shreveport-64616Shreveport, United StatesTaking people
- Louisiana Heart Center - SlidellSlidell, United StatesTaking people
- Frontier Clinical ResearchSmithfield, United StatesTaking people
- Cardio Metabolic InstituteSomerset, United StatesTaking people
- St. Louis Heart and Vascular, P.C.St Louis, United StatesTaking people
- Sundance Clinical Research, LLCSt Louis, United StatesTaking people
- IMA Clinical Research St. PetersburgSt. Petersburg, United StatesTaking people
- Cardiology Associates of Fairfield CountyStamford, United StatesTaking people
- Javara Inc.-Stephenville-68996Stephenville, United StatesTaking people
- Clinical Research Institute of Arizona, LLCSun City West, United StatesTaking people
- Universal Research Group LLCTacoma, United StatesTaking people
- Fiel Family & Sports MedicineTempe, United StatesTaking people
- Javara Research - ThomasvilleThomasville, United StatesTaking people
- Northwest Houston Heart CenterTomball, United StatesTaking people
- Cotton O'Neil Diabetes & Endocrinology CenterTopeka, United StatesTaking people
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, United StatesTaking people
- Oakland Medical CenterTroy, United StatesTaking people
- Atlanta Heart Specialists LLCTucker, United StatesTaking people
- Arizona Clinical TrialsTucson, United StatesTaking people
- Velocity Clinical Research-Union-68888Union, United StatesTaking people
- Preferred Primary Care Physicians-Uniontown-69137Uniontown, United StatesTaking people
- Covenant Metabolic Specialists, LLC - SarasotaUniversity Park, United StatesTaking people
- Blue Coast Research Center LLCVista, United StatesTaking people
- Velocity Clinical Research, WacoWaco, United StatesTaking people
- Aspirus Research InstituteWausau, United StatesNo longer taking part
- Allegiance Research SpecialistsWauwatosa, United StatesTaking people
- Cardiology Partners Clinical Research InstituteWellington, United StatesTaking people
- Texas Valley Clinical ResearchWeslaco, United StatesTaking people
- Suburban Research AssociatesWest Chester, United StatesTaking people
- Velocity Clinical Research-West Jordan-69043West Jordan, United StatesTaking people
- Monroe Research, LLCWest Monroe, United StatesTaking people
- Southgate Medical Group/ Southgate Medical ParkWest Seneca, United StatesTaking people
- Great Lakes Medical ResearchWestfield, United StatesTaking people
- Clinical Research Institute of Ohio, LLCWestlake, United StatesTaking people
- Tekton Research - WichitaWichita, United StatesTaking people
- Accellacare-Wilmington-67123Wilmington, United StatesTaking people
- Selma Medical Associates, WinchesterWinchester, United StatesTaking people
- Wake Forest University Health Sciences-Winston-Salem-61707Winston-Salem, United StatesTaking people
- Cardiology Consultants of PhiladelphiaYardley, United StatesTaking people
- Yuma Clinical TrialsYuma, United StatesTaking people
- Southern Clinical Research - ZacharyZachary, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Boehringer Ingelheim
- Trial code
- NCT07064473EU 2025-521188-11-00
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Treatment with an Mineralocorticoid receptor antagonist (MRA); 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; 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 amiloride or other potassium-sparing diuretic.