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

NCT07064473 · tracked via the Priya Life Science UK tracker

Sponsor

Boehringer Ingelheim

Phase

Phase 3

Started

2025-07-22

Last updated

2026-09-03

Condition(s) studied

Diabetes Mellitus, Type 2HypertensionCardiovascular Diseases

Investigational drug(s) / intervention(s)

VicadrostatEmpagliflozinPlacebo matching Vicadrostat

Vicadrostat: Vicadrostat

Empagliflozin: Empagliflozin

Placebo matching Vicadrostat: Placebo matching Vicadrostat

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Time to first event of cardiovascular (CV) death or heart failure event (HFE) — Up to 51 months

Trial sites (1147)

Facility	City	Region	Status
Pinnacle Research Group, LLC	Anniston	Alabama	Recruiting
Eastern Shore Research Group	Fairhope	Alabama	Recruiting
Lakeview Clinical Research	Guntersville	Alabama	Recruiting
Arizona Clinical Trials - Chandler	Chandler	Arizona	Recruiting
Elite Clinical Studies	Phoenix	Arizona	Recruiting
Clinical Research Institute of Arizona, LLC	Sun City West	Arizona	Recruiting
Fiel Family & Sports Medicine	Tempe	Arizona	Recruiting
Arizona Clinical Trials	Tucson	Arizona	Recruiting
Yuma Clinical Trials	Yuma	Arizona	Recruiting
National Heart Institute	Beverly Hills	California	Recruiting
Hope Clinical Research	Canoga Park	California	Recruiting
John Muir Physician Network Clinical Research Center	Concord	California	Recruiting
Velocity Clinical Research-Huntington Park	Huntington Park	California	Recruiting
Velocity Clinical Research, San Diego	La Mesa	California	Recruiting
First Valley Medical Group	Lancaster	California	Recruiting
ARK Clinical Research	Long Beach	California	Recruiting
Diabetes Associates Medical Group	Orange	California	Recruiting
Empire Clinical Research	Pomona	California	Recruiting
Velocity Clinical Research - San Bernardino	San Bernardino	California	Recruiting
Acclaim Clinical Research	San Diego	California	Recruiting
NorthBay Clinical Research, LLC	Santa Rosa	California	Recruiting
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California	Recruiting
Blue Coast Research Center, LLC	Vista	California	Recruiting
Rocky Mountain Regional VA Medical Center	Aurora	Colorado	Recruiting
OptumCare Clinical Trials, LLC	Golden	Colorado	Terminated
Cardiology Physicians of Fairfield County - Bridgeport	Bridgeport	Connecticut	Recruiting
CMR of Greater New Haven, LLC	Hamden	Connecticut	Recruiting
Cardiology Associates of Fairfield County	Stamford	Connecticut	Recruiting
Excel Medical Clinical Trials	Boca Raton	Florida	Recruiting
Clinical Research of West Florida, Inc.	Clearwater	Florida	Recruiting
Beautiful Minds Clinical Research Center	Cutler Bay	Florida	Recruiting
Hillcrest Medical Research	DeLand	Florida	Recruiting
University Clinical Research Deland, LLC	DeLand	Florida	Recruiting
Universal Axon Clinical Research	Doral	Florida	Recruiting
Northeast Research Institute	Fleming Island	Florida	Recruiting
Covenant Metabolic Specialists, LLC - Fort Myers	Fort Myers	Florida	Recruiting
Velocity Clinical Research-Hallandale Beach-67888	Hallandale	Florida	Recruiting
Northeast Research Institute	Jacksonville	Florida	Recruiting
Westside Center for Clinical Research	Jacksonville	Florida	Recruiting
East Coast Institute for Research, LLC - Southside	Jacksonville	Florida	Recruiting

+ 1107 more sites — see the full list on the official registry below.

On this site

📄 Jardiance (empagliflozin) drug profile →

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Other trials for the same condition

A Study of the ReCor Medical Paradise System in Clinical Hypertension Active, not recruiting

Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension Active, not recruiting

A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk Recruiting

The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension Active, not recruiting

Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07064473 on ClinicalTrials.gov ↗ ← All trials in the UK