Recruiting NCT07064473

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

Phase III Interventional Diabetes Mellitus, Type 2 Hypertension Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Vicadrostat, Empagliflozin, Placebo matching Vicadrostat.
Who it may be relevant to: Registry conditions: Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +46
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

Drug Vicadrostat
Vicadrostat
Drug Empagliflozin
Empagliflozin
Drug Placebo matching Vicadrostat
Placebo matching Vicadrostat

Primary outcome measures

Time to first event of cardiovascular (CV) death or heart failure event (HFE) [Time frame: Up to 51 months]

Secondary outcome measures (12)

Time to first event of cardiovascular (CV) death or hospitalisation for heart failure (HHF) [Time frame: Up to 51 months]
Absolute change from baseline in mean systolic blood pressure (SBP) [mmHg] at Week 24 [Time frame: At baseline and week 24]
Relative change from baseline in Urine Albumin Creatinine Ratio (UACR) [mg/g] at Week 24 [Time frame: At baseline and week 24]
Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death [Time frame: Up to 51 months]
Time to first event of CV death, HFE, non-fatal myocardial infarction (MI) or non-fatal stroke (4-point Major adverse cardiovascular events (MACE)) [Time frame: Up to 51 months]
Occurrences of all-cause hospitalisations (first and recurrent) [Time frame: Up to 51 months]
Time to first event of new-onset atrial fibrillation or atrial flutter (in participants without history of atrial fibrillation and atrial flutter) or CV death [Time frame: Up to 51 months]
Time to all-cause death [Time frame: Up to 51 months]
Time to CV death [Time frame: Up to 51 months]
Time to first HHF [Time frame: Up to 51 months]
Time to first event of new-onset HF or CV death [Time frame: Up to 51 months]
Occurrences of HHF (first and recurrent) [Time frame: Up to 51 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment