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

Trial tests new combo drug for diabetes, high blood pressure, and heart disease.

NCT: NCT07064473 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Boehringer Ingelheim · Started: 2025-05-09 · Est. Completion: 2029-12-21

Plain English Summary

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 is a Phase 3 clinical trial sponsored by Boehringer Ingelheim studying Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases. Tests if vicadrostat plus empagliflozin is better than placebo plus empagliflozin at preventing heart events. For adults with type 2 diabetes, high blood pressure, and existing cardiovascular disease. Involves taking a daily pill for up to 4 years and regular doctor visits for health checks. Alternatives include continuing current treatments for diabetes, high blood pressure, and heart disease. The trial aims to enroll 11800 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Must be at least 18 years old. Must have type 2 diabetes, high blood pressure, and established cardiovascular disease, all actively treated. Must have at least one additional risk factor for heart failure. Cannot have a history of heart failure or current treatment with certain heart medications like MRAs or specific blood pressure drugs. This trial is studying Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if the combination of vicadrostat and empagliflozin can reduce the chance of major heart problems or heart failure events over several years. The specific primary outcome measures are: Time to first event of cardiovascular (CV) death or heart failure event (HFE) (Up to 51 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a significant unmet need by investigating a new combination therapy to reduce cardiovascular risk in a high-risk patient population. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases, where improved treatment options are needed.

Investor Insight

This trial targets a large patient population with multiple chronic conditions, indicating a significant market potential for effective treatments. The sponsor's involvement suggests a strong commitme Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 11800 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if this trial is right for you, considering your specific health conditions and current medications. Participation involves taking a daily pill for up to 4 years and attending regular study visits for health monitoring and data collection. You will continue your existing treatments for diabetes, high blood pressure, and cardiovascular disease alongside the study medication or placebo. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full 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.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07064473?

NCT07064473 is a Phase 3 INTERVENTIONAL study titled "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." It is currently recruiting and is sponsored by Boehringer Ingelheim. The trial targets enrollment of 11800 participants.

What conditions does NCT07064473 study?

This trial investigates treatments for Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases. The primary condition under study is Diabetes Mellitus, Type 2.

What treatments are being tested in NCT07064473?

The interventions being studied include: Vicadrostat (DRUG), Empagliflozin (DRUG), Placebo matching Vicadrostat (DRUG). Vicadrostat

What does Phase 3 mean for NCT07064473?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT07064473?

This trial is currently "Recruiting." It started on 2025-05-09. The estimated completion date is 2029-12-21.

Who is sponsoring NCT07064473?

NCT07064473 is sponsored by Boehringer Ingelheim. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07064473?

The trial aims to enroll 11800 participants. The trial is currently recruiting and accepting new participants.

How is NCT07064473 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT07064473?

The primary outcome measures are: Time to first event of cardiovascular (CV) death or heart failure event (HFE) (Up to 51 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07064473 being conducted?

This trial is being conducted at 20 sites, including Anniston, Alabama; Fairhope, Alabama; Guntersville, Alabama; Chandler, Arizona and 16 more sites (United States).

Where can I find official information about NCT07064473?

The official record for NCT07064473 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07064473. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07064473 testing in simple terms?

Tests if vicadrostat plus empagliflozin is better than placebo plus empagliflozin at preventing heart events. For adults with type 2 diabetes, high blood pressure, and existing cardiovascular disease.

Why is this trial significant?

This trial addresses a significant unmet need by investigating a new combination therapy to reduce cardiovascular risk in a high-risk patient population. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT07064473?

Potential side effects may include those associated with vicadrostat, empagliflozin, or placebo. As with any cardiovascular trial, there's a risk of experiencing the very events the study aims to prevent, such as heart attacks or strokes. Specific risks related to blood pressure changes, electrolyte imbalances, or kidney function may be monitored. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07064473?

Ask your doctor if this trial is right for you, considering your specific health conditions and current medications. Participation involves taking a daily pill for up to 4 years and attending regular study visits for health monitoring and data collection. You will continue your existing treatments for diabetes, high blood pressure, and cardiovascular disease alongside the study medication or placebo. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07064473 signal from an investment perspective?

This trial targets a large patient population with multiple chronic conditions, indicating a significant market potential for effective treatments. The sponsor's involvement suggests a strong commitme This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Involves taking a daily pill for up to 4 years and regular doctor visits for health checks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.