Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of vicadrostat and empagliflozin combination in patients with type 2 diabetes, high blood pressure and cardiovascular disease

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people who have three medical conditions: Type 2 diabetes, hypertension (high blood pressure), and cardiovascular disease (heart and blood vessel disease). The research examines a combination of two medications: empagliflozin (Jardiance) and vicadrostat (BI 690517), compared to treatment with empagliflozin and placebo. Both medications are taken as tablets by mouth.

The purpose is to determine if using both medications together works better than empagliflozin alone in preventing serious heart-related health issues in people with these three conditions. The study will particularly look at how well this combination prevents death from heart problems and reduces the need for hospital visits due to heart failure.

Participants in this study will receive treatment for about 51 months. During this time, they will take either the combination of both medicines or empagliflozin with a placebo. Their blood pressure, kidney function, and heart health will be monitored throughout the study period. The medications being tested are designed to help manage blood sugar levels and blood pressure while protecting the heart and blood vessels.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication phase

    You will receive empagliflozin (Jardiance) 10 mg tablets to take by mouth

    You will also receive either vicadrostat (BI 690517) tablets or a placebo (inactive tablet that looks the same)

    You will need to take these medications daily as directed by your doctor

  2. Step 2

    24-week assessment period

    Your blood pressure will be measured and compared to your starting values

    Your urine will be tested to measure protein levels

    Your doctor will monitor your heart and kidney function

  3. Step 3

    Long-term follow-up

    Regular check-ups will continue until October 2029

    Your doctor will monitor for any heart-related events

    Your kidney function will be regularly assessed

    Your blood pressure will be checked at scheduled visits

  4. Step 4

    Health monitoring

    Your heart health will be regularly monitored throughout the study

    Any hospital visits related to heart problems will be documented

    Your blood pressure and general health status will be regularly checked

  5. Step 5

    Study completion

    The study will end in October 2029

    A final health assessment will be conducted

    Your doctor will provide recommendations for continuing care after the study ends

Who can join the trial?

7 criteria

  • Must be at least 18 years old when agreeing to participate in the study
  • Must provide written informed consent to participate in the trial
  • Both men and women can participate. Women who can become pregnant must use highly effective birth control methods that have less than 1% failure rate per year
  • Must have high blood pressure (hypertension) and be currently receiving medical treatment for it
  • Must have Type 2 diabetes and be currently receiving medical treatment for it
  • Must have established cardiovascular disease (heart and blood vessel disease) and be currently receiving medical treatment for it
  • Must have at least one additional risk factor that could lead to heart failure (a condition where the heart cannot pump blood effectively)

Who cannot join the trial?

14 criteria

  • History of severe allergic reactions to any of the study medications
  • Chronic kidney disease (severe problems with kidney function) requiring dialysis
  • Liver disease that significantly affects liver function
  • Uncontrolled high blood pressure (blood pressure consistently above 180/110 mmHg despite treatment)
  • Recent heart attack or stroke (within the last 3 months)
  • Current participation in other clinical trials
  • History of diabetic ketoacidosis (a serious complication of diabetes with high blood sugar) in the past 6 months
  • Pregnancy or planning to become pregnant during the study period
  • Breastfeeding mothers
  • Any condition that, in the doctor's opinion, could make participation unsafe
  • Unable to follow study procedures or attend scheduled visits
  • History of alcohol or drug abuse within the past year
  • Life-threatening illness with survival expected less than 1 year
  • Mental conditions that could interfere with study participation
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Vicadrostat (BI 690517) is a medication being studied for treating patients who have type 2 diabetes, high blood pressure, and cardiovascular disease. This medication is being tested as a new treatment option to help reduce cardiovascular-related health issues. Empagliflozin is a medication already used to treat type 2 diabetes. It works by helping the kidneys remove excess sugar from the blood through urine. It also has beneficial effects on heart health and can help reduce the risk of cardiovascular events in people with type 2 diabetes and heart disease. The trial is studying how these two medications work together compared to using empagliflozin alone. The goal is to see if the combination can better prevent serious heart-related problems, including death from cardiovascular causes, hospitalization due to heart failure, or urgent visits due to heart failure.

What is already known about the treatment

  • Vicadrostat

    An investigational oral medication currently in Phase III clinical trials for treating patients with cardiovascular disease, type 2 diabetes, and hypertension. The drug is being studied in combination with empagliflozin to evaluate its effectiveness in reducing cardiovascular death and heart failure-related events. While the exact molecular mechanism is still under investigation in clinical trials, it represents a new approach to managing multiple cardiovascular risk factors simultaneously.

  • Empagliflozin

    An oral sodium-glucose cotransporter-2 (SGLT2) inhibitor that works by reducing blood sugar levels by helping the kidneys remove glucose from the bloodstream. This medication is approved for treating type 2 diabetes and has shown significant benefits in reducing cardiovascular risks and heart failure hospitalizations. It is typically taken once daily and belongs to a class of drugs known as SGLT2 inhibitors, which have demonstrated protective effects on both heart and kidney function.

Investigated diseases

  • Cardiovascular Disease

    A group of conditions affecting the heart and blood vessels. It develops when arteries become narrowed or blocked due to the buildup of fatty deposits on their inner walls. The condition often progresses gradually over many years, affecting blood flow throughout the body. The disease can involve multiple parts of the cardiovascular system, including the heart muscle, valves, and circulation.

  • Type 2 Diabetes

    A chronic metabolic disorder characterized by high blood sugar levels due to the body's ineffective use of insulin. The condition develops when the body becomes resistant to insulin or doesn't produce enough insulin to maintain normal glucose levels. It typically develops gradually, with symptoms becoming more noticeable over time. The body's cells become less responsive to insulin, affecting how glucose is processed.

  • Hypertension

    A chronic condition where blood pressure in the arteries is consistently elevated above normal levels. The condition develops when the force of blood pushing against vessel walls remains too high for extended periods. It often develops gradually without noticeable symptoms. The increased pressure puts additional stress on the heart and blood vessels.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521188-11-00Protocol code1378-0041Estimated enrolment11 790 patientsSponsorBoehringer Ingelheim Espana S.A.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.