Diabetes Mellitus, Type 2 study: Vicadrostat vs Empagliflozin
Official title 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
ClinicalTrials.gov ID: NCT07064473
What this study is testing
What is Vicadrostat?
This is an investigational medicine being studied to see if it helps reduce cardiovascular risk in people with type 2 diabetes, high blood pressure, and cardiovascular disease. is designed to block an enzyme called HIF-2α, which may help the body manage blood pressure and heart health.
Also referred to as BI 690517.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if taking vicadrostat with empagliflozin reduces the chance of heart problems compared to taking a fake pill with empagliflozin.
- Who it's for
- The study is looking for adults who have type 2 diabetes, high blood pressure, and cardiovascular disease, but do not have a history of heart failure.
- What's involved
- Participants take one tablet daily, either the study medicine or a placebo, along with their usual diabetes and blood pressure medications. Doctors will regularly check health, take blood samples, and record any heart events or side effects.
- Time commitment
- The study lasts up to 4 years and 3 months, requiring regular visits to the study site.
- Phase 3: a large, late-stage study
- Time commitment: about 4 years
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
- A direct renin inhibitor (e.g. aliskiren)
See the full eligibility 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)
- 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Anniston, Alabama, United States
- Fairhope, Alabama, United States
- Guntersville, Alabama, United States
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Sun City West, Arizona, United States
- Tempe, Arizona, United States
- Tucson, Arizona, United States
- Yuma, Arizona, United States
- Beverly Hills, California, United States
- Canoga Park, California, United States
- Concord, California, United States
- Huntington Park, California, United States
- La Mesa, California, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Orange, California, United States
- Pomona, California, United States
- San Bernardino, California, United States
- San Diego, California, United States
+ 790 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anniston, Alabama, United States; Fairhope, Alabama, United States; Guntersville, Alabama, United States; Chandler, Arizona, United States; Phoenix, Arizona, United States; Sun City West, Arizona, United States and 804 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.