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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

Boehringer Ingelheim · NCT07064473

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
11800
US sites recruiting
201
Study start
July 22, 2025
Record last updated
October 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Vicadrostat; Empagliflozin; Placebo matching Vicadrostat

Conditions: Diabetes Mellitus, Type 2; Hypertension; Cardiovascular Diseases

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Pinnacle Research Group, LLC

    Anniston, AL 36207

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Eastern Shore Research Group

    Fairhope, AL 36532

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Lakeview Clinical Research

    Guntersville, AL 35976

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Arizona Clinical Trials - Chandler

    Chandler, AZ 85225

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Elite Clinical Studies

    Phoenix, AZ 85018

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Clinical Research Institute of Arizona, LLC

    Sun City West, AZ 85375

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Fiel Family & Sports Medicine

    Tempe, AZ 85283

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Arizona Clinical Trials

    Tucson, AZ 85711

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Yuma Clinical Trials

    Yuma, AZ 85364

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • National Heart Institute

    Beverly Hills, CA 90211

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Hope Clinical Research

    Canoga Park, CA 91303

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • John Muir Physician Network Clinical Research Center

    Concord, CA 94520

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Velocity Clinical Research-Huntington Park

    Huntington Park, CA 90255

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Velocity Clinical Research, San Diego

    La Mesa, CA 91942

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • First Valley Medical Group

    Lancaster, CA 93534

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • ARK Clinical Research

    Long Beach, CA 90815

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Diabetes Associates Medical Group

    Orange, CA 92868

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Empire Clinical Research

    Pomona, CA 91767

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Velocity Clinical Research - San Bernardino

    San Bernardino, CA 92408

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Acclaim Clinical Research

    San Diego, CA 92120

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • NorthBay Clinical Research, LLC

    Santa Rosa, CA 95405

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, CA 90502

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Blue Coast Research Center, LLC

    Vista, CA 92081

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Rocky Mountain Regional VA Medical Center

    Aurora, CO 80045

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Cardiology Physicians of Fairfield County - Bridgeport

    Bridgeport, CT 06606

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • CMR of Greater New Haven, LLC

    Hamden, CT 06517

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Cardiology Associates of Fairfield County

    Stamford, CT 06905

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Excel Medical Clinical Trials

    Boca Raton, FL 33434

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Clinical Research of West Florida, Inc.

    Clearwater, FL 33765

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Beautiful Minds Clinical Research Center

    Cutler Bay, FL 33157

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Hillcrest Medical Research

    DeLand, FL 32720

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • University Clinical Research Deland, LLC

    DeLand, FL 32720

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Universal Axon Clinical Research

    Doral, FL 33166

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Northeast Research Institute

    Fleming Island, FL 32003

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Covenant Metabolic Specialists, LLC - Fort Myers

    Fort Myers, FL 33912

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Velocity Clinical Research-Hallandale Beach-67888

    Hallandale, FL 33009

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Northeast Research Institute

    Jacksonville, FL 32204

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Westside Center for Clinical Research

    Jacksonville, FL 32205

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • East Coast Institute for Research, LLC - Southside

    Jacksonville, FL 32216

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Jacksonville Center for Clinical Research

    Jacksonville, FL 32216

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • East Coast Institute for Research - Lake City

    Lake City, FL 32055

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Clinical Research of Central Florida - Lakeland

    Lakeland, FL 33805

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Finlay Medical Research Corp

    Miami, FL 33126

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Optimus U Corporation-Miami-69452

    Miami, FL 33135

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Oceane7 Clinical Research

    Miami, FL 33144

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Research Institute of South Florida, Inc.

    Miami, FL 33173

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • IMIC Inc.

    Miami, FL 33176

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Alma Clinical Research, Inc.

    Miami, FL 33184

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Indago Research and Health Center

    Miami Lakes, FL 33016

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Advanced Research for Health Improvement, LLC

    Naples, FL 34102

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Suncoast Clinical Research

    New Port Richey, FL 34652

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Florida Institute for Clinical Research

    Orlando, FL 32825

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Ormond Beach Clinical Research

    Ormond Beach, FL 32174

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Cardiology Partners Clinical Research Institute

    Palm Beach Gardens, FL 33410

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Innovation Medical Research Center

    Palmetto Bay, FL 33157

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Center for Diabetes, Obesity and Metabolism

    Pembroke Pines, FL 33024

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Peace River Cardiovascular Center

    Port Charlotte, FL 33952

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Covenant Metabolic Specialists, LLC - Brandon

    Riverview, FL 33578

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • East Coast Institute for Research, LLC-Saint Augustine-63032

    Saint Augustine, FL 32086

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • IMA Clinical Research St. Petersburg

    St. Petersburg, FL 33704

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

+ 141 more on the official record.

Study contacts (from the official record)

  • Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com
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EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken… (NCT07064473) | Bored Studies