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NCT07064473

A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

11800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-22

Study Completion Date

2029-12-21

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Hypertension Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vicadrostat + empagliflozin treatment arm

Group Type EXPERIMENTAL

Vicadrostat

Intervention Type DRUG

Vicadrostat

Empagliflozin

Intervention Type DRUG

Empagliflozin

Vicadrostat-placebo + empagliflozin treatment arm

Group Type ACTIVE_COMPARATOR

Empagliflozin

Intervention Type DRUG

Empagliflozin

Placebo matching Vicadrostat

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

2025-521188-11-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

1378-0041

Identifier Type: -

Identifier Source: org_study_id

A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Vicadrostat + empagliflozin treatment arm

Vicadrostat

Empagliflozin

Vicadrostat-placebo + empagliflozin treatment arm

Empagliflozin

Placebo matching Vicadrostat

Interventions

Vicadrostat

Empagliflozin

Placebo matching Vicadrostat

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Boehringer Ingelheim

Responsible Party

Locations

Pinnacle Research Group, LLC

Eastern Shore Research Group

Lakeview Clinical Research

Arizona Clinical Trials - Chandler

Elite Clinical Studies

Clinical Research Institute of Arizona, LLC

Fiel Family & Sports Medicine

Arizona Clinical Trials

Yuma Clinical Trials

National Heart Institute - Beverly Hills

Hope Clinical Research

John Muir Physician Network Clinical Research Center

Velocity Clinical Research-Huntington Park

Velocity Clinical Research-La Mesa-69117

First Valley Medical Group

ARK Clinical Research

Diabetes Associates Medical Group

Empire Clinical Research

Velocity Clinical Research - San Bernardino

Acclaim Clinical Research

NorthBay Clinical Research, LLC

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

Blue Coast Research Center, LLC

Rocky Mountain Regional VA Medical Center

Optum Southwest

OptumCare Clinical Trials, LLC

Cardiology Physicians of Fairfield County - Bridgeport

Bridgeport Hospital

CMR of Greater New Haven, LLC

Cardiology Associates of Fairfield County

Excel Medical Clinical Trials

Clinical Research of West Florida, Inc.

Beautiful Minds Clinical Research Center

Hillcrest Medical Research

University Clinical Research Deland, LLC

Universal Axon Clinical Research

Northeast Research Institute

Covenant Metabolic Specialists, LLC - Fort Myers

Velocity Clinical Research-Hallandale Beach-67888

Indago Research and Health Center

Northeast Research Institute

Westside Center for Clinical Research

East Coast Institute for Research, LLC - Southside

Jacksonville Center for Clinical Research

Walgreens - Kissimmee - Site 4442

East Coast Institute for Research - Lake City

Finlay Medical Research Corp

Optimus U Corporation-Miami-69452

Oceane7 Clinical Research

Research Institute of South Florida, Inc.

IMIC Inc.

Alma Clinical Research, Inc.

Advanced Research for Health Improvement, LLC

Suncoast Clinical Research