A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 2; Hypertension; Cardiovascular Diseases
• Interventions: Drug: Vicadrostat; Drug: Empagliflozin; Drug: Placebo matching Vicadrostat

• Registration Number: NCT07064473
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-11
• Study First Posted: 2025-07-14
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Study Start: 2025-07-28
• Primary Completion: 2029-12-14
• Study Completion: 2029-12-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 11800

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vicadrostat + empagliflozin treatment arm	Vicadrostat	-
Vicadrostat + empagliflozin treatment arm	Empagliflozin	-
Vicadrostat-placebo + empagliflozin treatment arm	Empagliflozin	-
Vicadrostat-placebo + empagliflozin treatment arm	Placebo matching Vicadrostat	-

Primary Outcome Measures

Name	Time	Method
Time to first event of cardiovascular (CV) death or heart failure event (HFE)	Up to 51 months

Secondary Outcome Measures

Name	Time	Method
Time to first event of cardiovascular (CV) death or hospitalisation for heart failure (HHF)	Up to 51 months
Absolute change from baseline in mean systolic blood pressure (SBP) [mmHg] at Week 24	At baseline and week 24
Relative change from baseline in Urine Albumin Creatinine Ratio (UACR) [mg/g] at Week 24	At baseline and week 24
Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death	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))	Up to 51 months
Occurrences of all-cause hospitalisations (first and recurrent)	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	Up to 51 months
Time to all-cause death	Up to 51 months
Time to CV death	Up to 51 months
Time to first HHF	Up to 51 months
Time to first event of new-onset HF or CV death	Up to 51 months
Occurrences of HHF (first and recurrent)	Up to 51 months
Absolute change from baseline in mean diastolic blood pressure (DBP) [mmHg] at Week 24	At baseline and week 24

Trial Locations

Locations (847)

Pinnacle Research Group, LLC; 🇺🇸 Anniston, Alabama, United States

Eastern Shore Research Group; 🇺🇸 Fairhope, Alabama, United States

The Institute for Liver Health, LLC; 🇺🇸 Chandler, Arizona, United States

Elite Clinical Studies; 🇺🇸 Phoenix, Arizona, United States

Clinical Research Institute of Arizona, LLC; 🇺🇸 Sun City West, Arizona, United States

CCT Research - Tempe; 🇺🇸 Tempe, Arizona, United States

Arizona Clinical Trials; 🇺🇸 Tucson, Arizona, United States

Yuma Clinical Trials; 🇺🇸 Yuma, Arizona, United States

National Heart Institute - Beverly Hills; 🇺🇸 Beverly Hills, California, United States

John Muir Physician Network Clinical Research Center; 🇺🇸 Concord, California, United States

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