Vicadrostat + Empagliflozin for Type 2 Diabetes and Hypertension

Recruiting at 1220 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Must be taking: Antihypertensives, Antidiabetics, Cardiovascular drugs

Must not be taking: MRAs, Potassium-sparing diuretics, Renin inhibitors, others

Disqualifiers: Heart failure, Atrial fibrillation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2.5 to 4 years and 3 months

11800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new pill combination of vicadrostat (an experimental treatment) and empagliflozin (a medication used to lower blood sugar) can reduce the risk of heart problems in people with type 2 diabetes, high blood pressure, and cardiovascular disease. The trial compares this combination to a placebo, which resembles the medicine but contains no active ingredients. Participants with these conditions, who haven't experienced heart failure, may be suitable candidates. They will take one pill daily while continuing their usual medications. Regular check-ups will monitor health and any heart-related events throughout the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications to join the trial?

You can continue taking your current medications for type 2 diabetes, high blood pressure, and cardiovascular disease while participating in the trial. However, you cannot be on certain medications like mineralocorticoid receptor antagonists, potassium-sparing diuretics, or direct renin inhibitors.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining vicadrostat and empagliflozin may benefit individuals with kidney problems. Studies so far indicate that this combination reduces albuminuria, a condition characterized by excessive protein in the urine, without major safety concerns.

While specific safety data for vicadrostat with empagliflozin is still being collected, empagliflozin has already received FDA approval for treating type 2 diabetes and is generally considered safe, though some side effects may occur. Since this trial is in a late phase, earlier tests did not reveal major safety issues, but further research is needed to confirm this.

Participants should consult with the trial team to understand potential side effects and determine if joining the trial is appropriate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 2 diabetes and hypertension?

Researchers are excited about Vicadrostat combined with Empagliflozin because this duo brings a fresh approach to treating Type 2 Diabetes and Hypertension. Unlike most treatments that typically focus on controlling blood sugar or blood pressure separately, Vicadrostat targets an enzyme involved in blood pressure regulation, while Empagliflozin helps manage blood sugar by removing excess glucose through urine. This dual-action approach not only addresses both conditions simultaneously but also offers a promising alternative for patients who may not respond well to standard treatments. By tackling both issues at their core, this combination has the potential to improve overall health outcomes more effectively.

What evidence suggests that the combination of vicadrostat and empagliflozin might be an effective treatment for type 2 diabetes and hypertension?

Research has shown that combining vicadrostat with empagliflozin, which participants in this trial may receive, may help lower the risk of heart problems. Studies indicate that this combination can significantly reduce the systolic blood pressure by 7.8 mmHg compared to a placebo. Vicadrostat also lowers albumin levels in urine, indicating kidney issues, in people with chronic kidney disease. Although vicadrostat might cause a temporary drop in kidney function, it has the potential to improve heart, kidney, and overall health. These effects suggest that the combination could effectively manage type 2 diabetes and high blood pressure, reducing the risk of heart problems. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults with type 2 diabetes, high blood pressure, and cardiovascular disease can join this study. They must not have a history of heart failure. Participants will continue their usual medications for these conditions while in the trial.

Inclusion Criteria

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)

At least one additional risk factor for developing heart failure (HF)

Exclusion Criteria

I am taking amiloride or a similar water pill that saves potassium.

I have a history of heart failure or have been hospitalized or treated for it.

My heart rate is over 110 bpm due to atrial fibrillation or flutter, confirmed by an ECG.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take vicadrostat and empagliflozin or placebo and empagliflozin tablets daily

2.5 to 4 years and 3 months

Regular visits to the study site

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Empagliflozin
• Vicadrostat

Trial Overview The trial is testing Vicadrostat taken with Empagliflozin versus a placebo (a pill without medicine) combined with Empagliflozin to see if it reduces cardiovascular risk. It's randomized, so participants have an equal chance of being in either group.

How Is the Trial Designed?

Group I: Vicadrostat + empagliflozin treatment arm Experimental Treatment 2 Interventions

Group II: Vicadrostat-placebo + empagliflozin treatment arm Active Control 2 Interventions

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07064473

NCT07064473 | A Study to Test Vicadrostat (BI 690517) ... 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 ...

2. academic.oup.com academic.oup.com/ndt/article/40/Supplement_3/gfaf116.0480/8295047

#3201 Effects of vicadrostat with and without empagliflozin in ... Vicadrostat with or without empagliflozin reduced albuminuria irrespective of baseline BMI dichotomized at 30 kg/m2 in participants with CKD and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12209857/

a rationale for the EASi-KIDNEY trial In combination with empagliflozin, systolic BP was 7.8 mmHg lower with vicadrostat 10 mg versus placebo [81]. Vicadrostat caused a reversible acute eGFR dip in ...

4. boehringer-ingelheim.com boehringer-ingelheim.com/human-health/heart-diseases/heart-failure/easi-hf-phase-iii-trial-patients-hfpef

EASi-HF™ Phase III trial in patients with HFpEF There is potential for vicadrostat with empagliflozin to improve overall cardiovascular, renal and metabolic health, as positive outcomes in one condition may ...

5. trialx.com trialx.com/clinical-trials/listings/300725/a-study-to-test-vicadrostat-bi-690517-taken-together-with-empagliflozin-in-people-with-type-2-diabetes-high-blood-pressure-and-cardiovascular-disease/

A Study to Test Vicadrostat (BI 690517 ... 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 ...

6. boehringer-ingelheim.com boehringer-ingelheim.com/science-innovation/human-health-innovation/clinical-pipeline/vicadrostat-bi-690517-empagliflozin

Vicadrostat (BI 690517) / empagliflozin Boehringer Ingelheim is investigating the potential benefits of vicadrostat (BI 690517)/empagliflozin, a novel selective aldosterone synthase inhibitor/SGLT2 ...

7. registry.healthresearch.ph registry.healthresearch.ph/index.php/registry?view=research&layout=details&cid=8985

Registry - Research Details The primary objective is to demonstrate the superiority of the combination of vicadrostat 10 mg and empagliflozin 10 mg compared with ...

8. trial.medpath.com trial.medpath.com/clinical-trial/7b39aedf188104fd/nct07064473-vicadrostat-empagliflozin-type-2-diabetes-cardiovascular-disease

A Study to Test Vicadrostat (BI 690517) Taken Together With ... 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 ...