ClinicalTrials.gov record
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
ClinicalTrials.gov ID: NCT07064473
Public ClinicalTrials.gov record NCT07064473. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07064473
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 11,800 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 21, 2025
- Primary completion
- Dec 13, 2029
- Completion
- Dec 20, 2029
- Last update posted
- Aug 19, 2026
2025 – 2029
United States locations
- U.S. sites
- 210
- U.S. states
- 39
- U.S. cities
- 176
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | Recruiting |
| Eastern Shore Research Group | Fairhope | Alabama | 36532 | Recruiting |
| Lakeview Clinical Research | Guntersville | Alabama | 35976 | Recruiting |
| Arizona Clinical Trials - Chandler | Chandler | Arizona | 85225 | Recruiting |
| Elite Clinical Studies | Phoenix | Arizona | 85018 | Recruiting |
| Clinical Research Institute of Arizona, LLC | Sun City West | Arizona | 85375 | Recruiting |
| Fiel Family & Sports Medicine | Tempe | Arizona | 85283 | Recruiting |
| Arizona Clinical Trials | Tucson | Arizona | 85711 | Recruiting |
| Yuma Clinical Trials | Yuma | Arizona | 85364 | Recruiting |
| National Heart Institute | Beverly Hills | California | 90211 | Recruiting |
| Hope Clinical Research | Canoga Park | California | 91303 | Recruiting |
| John Muir Physician Network Clinical Research Center | Concord | California | 94520 | Recruiting |
| Velocity Clinical Research-Huntington Park | Huntington Park | California | 90255 | Recruiting |
| Velocity Clinical Research, San Diego | La Mesa | California | 91942 | Recruiting |
| First Valley Medical Group | Lancaster | California | 93534 | Recruiting |
| ARK Clinical Research | Long Beach | California | 90815 | Recruiting |
| Diabetes Associates Medical Group | Orange | California | 92868 | Recruiting |
| Empire Clinical Research | Pomona | California | 91767 | Recruiting |
| Velocity Clinical Research - San Bernardino | San Bernardino | California | 92408 | Recruiting |
| Acclaim Clinical Research | San Diego | California | 92120 | Recruiting |
| NorthBay Clinical Research, LLC | Santa Rosa | California | 95405 | Recruiting |
| The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | Recruiting |
| Blue Coast Research Center, LLC | Vista | California | 92081 | Recruiting |
| Rocky Mountain Regional VA Medical Center | Aurora | Colorado | 80045 | Recruiting |
| OptumCare Clinical Trials, LLC | Golden | Colorado | 80401 | Terminated |
| Cardiology Physicians of Fairfield County - Bridgeport | Bridgeport | Connecticut | 06606 | Recruiting |
| CMR of Greater New Haven, LLC | Hamden | Connecticut | 06517 | Recruiting |
| Cardiology Associates of Fairfield County | Stamford | Connecticut | 06905 | Recruiting |
| Excel Medical Clinical Trials | Boca Raton | Florida | 33434 | Recruiting |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | Recruiting |
| Beautiful Minds Clinical Research Center | Cutler Bay | Florida | 33157 | Recruiting |
| Hillcrest Medical Research | DeLand | Florida | 32720 | Recruiting |
| University Clinical Research Deland, LLC | DeLand | Florida | 32720 | Recruiting |
| Universal Axon Clinical Research | Doral | Florida | 33166 | Recruiting |
| Northeast Research Institute | Fleming Island | Florida | 32003 | Recruiting |
| Covenant Metabolic Specialists, LLC - Fort Myers | Fort Myers | Florida | 33912 | Recruiting |
| Velocity Clinical Research-Hallandale Beach-67888 | Hallandale | Florida | 33009 | Recruiting |
| Northeast Research Institute | Jacksonville | Florida | 32204 | Recruiting |
| Westside Center for Clinical Research | Jacksonville | Florida | 32205 | Recruiting |
| East Coast Institute for Research, LLC - Southside | Jacksonville | Florida | 32216 | Recruiting |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | Recruiting |
| Walgreens - Kissimmee - Site 4442 | Kissimmee | Florida | 34736 | Completed |
| East Coast Institute for Research - Lake City | Lake City | Florida | 32055 | Recruiting |
| Clinical Research of Central Florida - Lakeland | Lakeland | Florida | 33805 | Recruiting |
| Finlay Medical Research Corp | Miami | Florida | 33126 | Recruiting |
| Optimus U Corporation-Miami-69452 | Miami | Florida | 33135 | Recruiting |
| Oceane7 Clinical Research | Miami | Florida | 33144 | Recruiting |
| Research Institute of South Florida, Inc. | Miami | Florida | 33173 | Recruiting |
| IMIC Inc. | Miami | Florida | 33176 | Recruiting |
| Alma Clinical Research, Inc. | Miami | Florida | 33184 | Recruiting |
| Indago Research and Health Center | Miami Lakes | Florida | 33016 | Recruiting |
| Advanced Research for Health Improvement, LLC | Naples | Florida | 34102 | Recruiting |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | Recruiting |
| Florida Institute for Clinical Research | Orlando | Florida | 32825 | Recruiting |
| Ormond Beach Clinical Research | Ormond Beach | Florida | 32174 | Recruiting |
| Cardiology Partners Clinical Research Institute | Palm Beach Gardens | Florida | 33410 | Recruiting |
| Innovation Medical Research Center | Palmetto Bay | Florida | 33157 | Recruiting |
| Center for Diabetes, Obesity and Metabolism | Pembroke Pines | Florida | 33024 | Recruiting |
| Peace River Cardiovascular Center | Port Charlotte | Florida | 33952 | Recruiting |
| Covenant Metabolic Specialists, LLC - Brandon | Riverview | Florida | 33578 | Recruiting |
| East Coast Institute for Research, LLC-Saint Augustine-63032 | Saint Augustine | Florida | 32086 | Recruiting |
| IMA Clinical Research St. Petersburg | St. Petersburg | Florida | 33704 | Recruiting |
| Covenant Metabolic Specialists, LLC - Sarasota | University Park | Florida | 34201 | Recruiting |
| Cardiology Partners Clinical Research Institute | Wellington | Florida | 33449 | Recruiting |
| Centricity Research, Endocrine Consultants | Columbus | Georgia | 31904 | Recruiting |
| NSC Research Inc | Johns Creek | Georgia | 30024 | Recruiting |
| Physicians Research Associates, LLC | Lawrenceville | Georgia | 30046 | Not yet recruiting |
| The Jones Center Clinical Research, LLC | Macon | Georgia | 31210 | Recruiting |
| Urban Family Practice Associates, PC | Marietta | Georgia | 30067 | Recruiting |
| Javara-Savannah-67450 | Savannah | Georgia | 31406 | Recruiting |
| Javara Research - Thomasville | Thomasville | Georgia | 31792 | Recruiting |
| Atlanta Heart Specialists, LLC | Tucker | Georgia | 30084 | Recruiting |
| Pacific Diabetes & Endocrine Center | Honolulu | Hawaii | 96817 | Recruiting |
| Rocky Mountain Clinical Research - Idaho Falls | Idaho Falls | Idaho | 83404 | Recruiting |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | Recruiting |
| Walgreens - Chicago - Site 162 | Chicago | Illinois | 60615 | Completed |
| Accellacare of Duly - Lombard | Lombard | Illinois | 60148 | Recruiting |
| Accellacare of Duly | Oak Lawn | Illinois | 60453 | Recruiting |
| American Health Network - Avon | Avon | Indiana | 46123 | Recruiting |
| Midwest Cardiovascular Research and Education Foundation | Elkhart | Indiana | 46514 | Recruiting |
| American Health Network - Franklin | Franklin | Indiana | 46131 | Terminated |
| American Health Network - Greenfield | Greenfield | Indiana | 46140 | Recruiting |
| American Health Network - Muncie | Muncie | Indiana | 47304 | Recruiting |
| Reid Physician Associates | Richmond | Indiana | 47374 | Recruiting |
| AMR El Dorado | El Dorado | Kansas | 67042 | Recruiting |
| Cotton O'Neil Diabetes & Endocrinology Center | Topeka | Kansas | 66606 | Recruiting |
| Tekton Research - Wichita | Wichita | Kansas | 67218 | Recruiting |
| Qualmedica Research - Bowling Green | Bowling Green | Kentucky | 42101 | Recruiting |
| The Research Group of Lexington | Lexington | Kentucky | 40503 | Recruiting |
| Research Integrity, LLC | Owensboro | Kentucky | 42303 | Recruiting |
| Grace Research, LLC-Bossier City-51040 | Bossier City | Louisiana | 71111 | Recruiting |
| Louisiana Heart Center - Covington | Covington | Louisiana | 70433 | Recruiting |
| IMA Clinical Research Monroe | Monroe | Louisiana | 71201 | Recruiting |
| Grace Research, LLC-Shreveport-64616 | Shreveport | Louisiana | 71105 | Recruiting |
| Louisiana Heart Center - Slidell | Slidell | Louisiana | 70458 | Recruiting |
| Monroe Research, LLC | West Monroe | Louisiana | 71291 | Recruiting |
| Southern Clinical Research - Zachary | Zachary | Louisiana | 70791 | Recruiting |
| Ascension Saint Agnes Heart Care | Baltimore | Maryland | 21229 | Recruiting |
| Medstar Montgomery Medical Center | Olney | Maryland | 20832 | Not yet recruiting |
| MD Medical Research | Oxon Hill | Maryland | 20745 | Recruiting |
| TidalHealth, Inc. | Salisbury | Maryland | 21804 | Recruiting |
| Walgreens - Malden - Site 4966 | Malden | Massachusetts | 02148 | Completed |
| ActivMed Practices & Research | Methuen | Massachusetts | 01844 | Recruiting |
| Revival Research Institute, LLC - Dearborn | Dearborn | Michigan | 48126 | Recruiting |
| Aa Mrc Llc | Flint | Michigan | 48504 | Recruiting |
| Elite Research Center, LLC | Flint | Michigan | 48532 | Recruiting |
| Oakland Medical Center | Troy | Michigan | 48085 | Recruiting |
| Prime Health and Wellness | Fayette | Mississippi | 39069 | Recruiting |
| Jefferson City Medical Group | Jefferson City | Missouri | 65109 | Recruiting |
| Clinical Research Consultants, LLC | Kansas City | Missouri | 64111 | Recruiting |
| St. Louis Heart and Vascular, P.C. | St Louis | Missouri | 63136 | Recruiting |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | Recruiting |
| Billings Clinic - Billings | Billings | Montana | 59101 | Recruiting |
| Methodist Physicians Clinic | Fremont | Nebraska | 68025 | Recruiting |
| Quality Clinical Research - Omaha | Omaha | Nebraska | 68114 | Recruiting |
| Las Vegas Clinical Trials | Las Vegas | Nevada | 89030 | Recruiting |
| AB Clinical Trials | Las Vegas | Nevada | 89119 | Recruiting |
| Palm Research Center | Las Vegas | Nevada | 89128 | Recruiting |
| Vector Clinical Trials - Las Vegas | Las Vegas | Nevada | 89128 | Recruiting |
| Palm Research Center | Las Vegas | Nevada | 89148 | Recruiting |
| Walgreens - North Las Vegas - Site 5814 | North Las Vegas | Nevada | 89032 | Completed |
| Advanced Heart Care, LLC | Bridgewater | New Jersey | 08807 | Recruiting |
| NJ Heart LLC | Linden | New Jersey | 07036 | Recruiting |
| Cardio Metabolic Institute | Somerset | New Jersey | 08873 | Recruiting |
| New Mexico Clinical Research and Osteoporosis Center, Inc. | Albuquerque | New Mexico | 87106 | Recruiting |
| IMA Clinical Research Albuquerque | Albuquerque | New Mexico | 87109 | Recruiting |
| Albany Med Health System - Washington Avenue Extension | Albany | New York | 12203 | Recruiting |
| Velocity Clinical Research - Binghamton | Binghamton | New York | 13905 | Recruiting |
| RCR - Buffalo | Buffalo | New York | 14217 | Recruiting |
| NYC Research Inc. | New York | New York | 10016 | Recruiting |
| New York Cardiovascular Specialist PC | New York | New York | 10035 | Recruiting |
| Northwell Health - Peconic Bay Medical Group at Riverhead | Riverhead | New York | 11091 | Recruiting |
| Rochester Clinical Research, Inc | Rochester | New York | 14609 | Recruiting |
| Saratoga Clinical Research, LLC | Saratoga Springs | New York | 12866 | Recruiting |
| Southgate Medical Group/ Southgate Medical Park | West Seneca | New York | 14224 | Recruiting |
| Great Lakes Medical Research | Westfield | New York | 14787 | Recruiting |
| Cary Cardiology | Cary | North Carolina | 27518 | Recruiting |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | Recruiting |
| Physicians East, PA | Greenville | North Carolina | 27834 | Recruiting |
| IMA Clinical Research Lenoir | Lenoir | North Carolina | 28645 | Recruiting |
| Accellacare-Mooresville-69123 | Mooresville | North Carolina | 28117 | Recruiting |
| Lucas Research, Inc. | Morehead City | North Carolina | 28557 | Recruiting |
| Accellacare-Wilmington-67123 | Wilmington | North Carolina | 28401 | Recruiting |
| Wake Forest University Health Sciences-Winston-Salem-61707 | Winston-Salem | North Carolina | 27157 | Recruiting |
| Lillestol Research, LLC | Fargo | North Dakota | 58104 | Recruiting |
| The Christ Hospital | Cincinnati | Ohio | 45219 | Recruiting |
| Velocity Clinical Research-Cincinnati-69044 | Cincinnati | Ohio | 45242 | Recruiting |
| Centricity Research-Columbus-68879 | Columbus | Ohio | 43213 | Recruiting |
| Remington-Davis Clinical Research, Inc | Columbus | Ohio | 43215 | Recruiting |
| Clinical Research Institute of Ohio, LLC | Westlake | Ohio | 44145 | Recruiting |
| Tekton Research-Edmond-68875 | Edmond | Oklahoma | 73013 | Recruiting |
| Tekton Research Oklahoma City | Oklahoma City | Oklahoma | 73134 | Recruiting |
| South Oklahoma Heart Research Group | Oklahoma City | Oklahoma | 73135 | Recruiting |
| Heritage Valley Medical Group | Beaver | Pennsylvania | 15009 | Recruiting |
| Capital Area Research, LLC | Camp Hill | Pennsylvania | 17011 | Recruiting |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Tristar Clinical Investigations PC | Philadelphia | Pennsylvania | 19114 | Recruiting |
| Preferred Primary Care Physicians-Pittsburgh-63932 | Pittsburgh | Pennsylvania | 15236 | Recruiting |
| Preferred Primary Care Physicians, Inc | Pittsburgh | Pennsylvania | 15243 | Recruiting |
| Frontier Clinical Research LLC - Scottdale | Scottdale | Pennsylvania | 15683 | Recruiting |
| Frontier Clinical Research | Smithfield | Pennsylvania | 15478 | Recruiting |
| Preferred Primary Care Physicians-Uniontown-69137 | Uniontown | Pennsylvania | 15401 | Recruiting |
| Suburban Research Associates | West Chester | Pennsylvania | 19380 | Recruiting |
| Cardiology Consultants of Philadelphia | Yardley | Pennsylvania | 19067 | Recruiting |
| Piedmont Research Partners, LLC | Fort Mill | South Carolina | 29707 | Recruiting |
| Velocity Clinical Research-Gaffney-69046 | Gaffney | South Carolina | 29340 | Recruiting |
| Tribe Clinical Research LLC | Greenville | South Carolina | 29607 | Recruiting |
| Velocity Clinical Research-Union-68888 | Union | South Carolina | 29379 | Recruiting |
| Dunes Clinical Research | Dakota Dunes | South Dakota | 57049 | Recruiting |
| Alliance for Multispecialty Research, LLC-Knoxville-69693 | Knoxville | Tennessee | 37909 | Recruiting |
| Pinnacle Clinical Research - Austin | Austin | Texas | 78757 | Recruiting |
| South Texas Research Institute - Brownsville | Brownsville | Texas | 78520 | Recruiting |
| Headlands Research - Brownsville | Brownsville | Texas | 78526 | Recruiting |
| Soltero Cardiovascular Research Center | Dallas | Texas | 75226 | Recruiting |
| Javara Inc / Texas Health Care, PLLC | Dallas | Texas | 75230 | Recruiting |
| North Texas Endocrine Center | Dallas | Texas | 75231 | Recruiting |
| Southwest Family Medicine Associates | Dallas | Texas | 75235 | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| Academy Of Diabetes, Thyroid And Endocrine, PA | El Paso | Texas | 79935 | Recruiting |
| Care United Research | Forney | Texas | 75126 | Recruiting |
| Texas Health Physicians Group | Fort Worth | Texas | 76107 | Recruiting |
| Diabetes and Thyroid Center of Fort Worth | Fort Worth | Texas | 76132 | Recruiting |
| Victorium Clinical Research | Houston | Texas | 77024 | Recruiting |
| Houston Research Institute | Houston | Texas | 77079 | Recruiting |
| Epic Clinical Research | Lewisville | Texas | 75057 | Recruiting |
| Southern Endocrinology Associates | Mesquite | Texas | 75149 | Recruiting |
| IMA Clinical Research San Antonio | San Antonio | Texas | 78229 | Recruiting |
| Pinnacle Clinical Research, LLC | San Antonio | Texas | 78229 | Recruiting |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | Recruiting |
| Endeavor Clinical Trials | San Antonio | Texas | 78240 | Recruiting |
| Tekton Research-San Antonio-68916 | San Antonio | Texas | 78258 | Recruiting |
| Javara Inc. and Privia Medical Group Gulf Coast, PLLC | San Marcos | Texas | 78666 | Recruiting |
| Consano Clinical Research | Shavano Park | Texas | 78231 | Recruiting |
| Sherman Clinical Research | Sherman | Texas | 75090 | Recruiting |
| Javara Inc.-Stephenville-68996 | Stephenville | Texas | 76401 | Recruiting |
| Northwest Houston Heart Center | Tomball | Texas | 77375 | Recruiting |
| Velocity Clinical Research, Waco | Waco | Texas | 76710 | Recruiting |
| Texas Valley Clinical Research | Weslaco | Texas | 78596 | Recruiting |
| Olympus Family Medicine | Salt Lake City | Utah | 84117 | Recruiting |
| Velocity Clinical Research-West Jordan-69043 | West Jordan | Utah | 84088 | Recruiting |
| Seven Corners Medical Center | Falls Church | Virginia | 22044 | Recruiting |
| Carient Heart and Vascular | Manassas | Virginia | 20109 | Recruiting |
| York Clinical Research | Norfolk | Virginia | 23504 | Recruiting |
| Dominion Medical Associates - Downtown | Richmond | Virginia | 23219 | Recruiting |
| Selma Medical Associates, Winchester | Winchester | Virginia | 22601 | Recruiting |
| Universal Research Group, LLC | Tacoma | Washington | 98405 | Recruiting |
| Frontier Clinical Research, LLC - Morgantown | Morgantown | West Virginia | 26505 | Recruiting |
| Clinical Investigation Specialists, Inc.-Kenosha-69111 | Kenosha | Wisconsin | 53144 | Recruiting |
| Aspirus Research Institute | Wausau | Wisconsin | 54401 | Recruiting |
| Allegiance Research Specialists | Wauwatosa | Wisconsin | 53226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 935 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07064473, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 19, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07064473 live on ClinicalTrials.gov.