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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
Sponsor: Boehringer Ingelheim
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
11800
Start Date
2025-07-22
Completion Date
2029-12-21
Last Updated
2026-10-28
Healthy Volunteers
No
Interventions
Vicadrostat
Vicadrostat
Empagliflozin
Empagliflozin
Placebo matching Vicadrostat
Placebo matching Vicadrostat
Locations (1142)
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Eastern Shore Research Group
Fairhope, Alabama, United States
Lakeview Clinical Research
Guntersville, Alabama, United States
Arizona Clinical Trials - Chandler
Chandler, Arizona, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Clinical Research Institute of Arizona, LLC
Sun City West, Arizona, United States
Fiel Family & Sports Medicine
Tempe, Arizona, United States
Arizona Clinical Trials
Tucson, Arizona, United States
Yuma Clinical Trials
Yuma, Arizona, United States
National Heart Institute
Beverly Hills, California, United States
Hope Clinical Research
Canoga Park, California, United States
John Muir Physician Network Clinical Research Center
Concord, California, United States
Velocity Clinical Research-Huntington Park
Huntington Park, California, United States
Velocity Clinical Research, San Diego
La Mesa, California, United States
First Valley Medical Group
Lancaster, California, United States
ARK Clinical Research
Long Beach, California, United States
Diabetes Associates Medical Group
Orange, California, United States
Empire Clinical Research
Pomona, California, United States
Velocity Clinical Research - San Bernardino
San Bernardino, California, United States
Acclaim Clinical Research
San Diego, California, United States
NorthBay Clinical Research, LLC
Santa Rosa, California, United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Blue Coast Research Center, LLC
Vista, California, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
OptumCare Clinical Trials, LLC
Golden, Colorado, United States
Cardiology Physicians of Fairfield County - Bridgeport
Bridgeport, Connecticut, United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, United States
Cardiology Associates of Fairfield County
Stamford, Connecticut, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, United States
Hillcrest Medical Research
DeLand, Florida, United States
University Clinical Research Deland, LLC
DeLand, Florida, United States
Universal Axon Clinical Research
Doral, Florida, United States
Northeast Research Institute
Fleming Island, Florida, United States
Covenant Metabolic Specialists, LLC - Fort Myers
Fort Myers, Florida, United States
Velocity Clinical Research-Hallandale Beach-67888
Hallandale, Florida, United States
Northeast Research Institute
Jacksonville, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
East Coast Institute for Research, LLC - Southside
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Walgreens - Kissimmee - Site 4442
Kissimmee, Florida, United States
East Coast Institute for Research - Lake City
Lake City, Florida, United States
Clinical Research of Central Florida - Lakeland
Lakeland, Florida, United States
Finlay Medical Research Corp
Miami, Florida, United States
Optimus U Corporation-Miami-69452
Miami, Florida, United States
Oceane7 Clinical Research
Miami, Florida, United States
Research Institute of South Florida, Inc.
Miami, Florida, United States
IMIC Inc.
Miami, Florida, United States
Alma Clinical Research, Inc.
Miami, Florida, United States
Indago Research and Health Center
Miami Lakes, Florida, United States
Advanced Research for Health Improvement, LLC
Naples, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Florida Institute for Clinical Research
Orlando, Florida, United States
Ormond Beach Clinical Research
Ormond Beach, Florida, United States
Cardiology Partners Clinical Research Institute
Palm Beach Gardens, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
Center for Diabetes, Obesity and Metabolism
Pembroke Pines, Florida, United States
Peace River Cardiovascular Center
Port Charlotte, Florida, United States
Covenant Metabolic Specialists, LLC - Brandon
Riverview, Florida, United States
East Coast Institute for Research, LLC-Saint Augustine-63032
Saint Augustine, Florida, United States
IMA Clinical Research St. Petersburg
St. Petersburg, Florida, United States
Covenant Metabolic Specialists, LLC - Sarasota
University Park, Florida, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States
Centricity Research, Endocrine Consultants
Columbus, Georgia, United States
NSC Research Inc
Johns Creek, Georgia, United States
The Jones Center Clinical Research, LLC
Macon, Georgia, United States
Urban Family Practice Associates, PC
Marietta, Georgia, United States
Javara-Savannah-67450
Savannah, Georgia, United States
Javara Research - Thomasville
Thomasville, Georgia, United States
Atlanta Heart Specialists, LLC
Tucker, Georgia, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, United States
Rocky Mountain Clinical Research - Idaho Falls
Idaho Falls, Idaho, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Walgreens - Chicago - Site 162
Chicago, Illinois, United States
Accellacare of Duly - Lombard
Lombard, Illinois, United States
Accellacare of Duly
Oak Lawn, Illinois, United States
American Health Network - Avon
Avon, Indiana, United States
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, United States
American Health Network - Franklin
Franklin, Indiana, United States
American Health Network - Greenfield
Greenfield, Indiana, United States
American Health Network - Muncie
Muncie, Indiana, United States
Reid Physician Associates
Richmond, Indiana, United States
AMR El Dorado
El Dorado, Kansas, United States
Cotton O'Neil Diabetes & Endocrinology Center
Topeka, Kansas, United States
Tekton Research - Wichita
Wichita, Kansas, United States
Qualmedica Research - Bowling Green
Bowling Green, Kentucky, United States
The Research Group of Lexington
Lexington, Kentucky, United States
Research Integrity, LLC
Owensboro, Kentucky, United States
Grace Research, LLC-Bossier City-51040
Bossier City, Louisiana, United States
Louisiana Heart Center - Covington
Covington, Louisiana, United States
IMA Clinical Research Monroe
Monroe, Louisiana, United States
Grace Research, LLC-Shreveport-64616
Shreveport, Louisiana, United States
Louisiana Heart Center - Slidell
Slidell, Louisiana, United States
Monroe Research, LLC
West Monroe, Louisiana, United States
Southern Clinical Research - Zachary
Zachary, Louisiana, United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, United States
Medstar Montgomery Medical Center
Olney, Maryland, United States
MD Medical Research
Oxon Hill, Maryland, United States
TidalHealth, Inc.
Salisbury, Maryland, United States