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

NCT07064473
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
11,800
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Lead sponsor
Boehringer Ingelheim
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Start date
2025-07-22
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Number of sites
1,147
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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.
clinicaltrials.gov
Short 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
Official title
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-12-21
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First posted
2025-07-14
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Registry last updated
2026-08-20
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Primary completion date
2029-12-14
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Start date
2025-07-22
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Participants
11,800
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Participant count basis
Estimated
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Planned participants
11,800
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Protocol amendments
1
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Number of sites
1,147
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Boehringer Ingelheim
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07064473
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ClinicalTrials.gov ID
NCT07064473
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Time to first event of cardiovascular (CV) death or heart failure event (HFE)

    Timeframe: Up to 51 months

  1. Time to first event of cardiovascular (CV) death or hospitalisation for heart failure (HHF)

    Timeframe: Up to 51 months

  2. Absolute change from baseline in mean systolic blood pressure (SBP) [mmHg] at Week 24

    Timeframe: At baseline and week 24

  3. Relative change from baseline in Urine Albumin Creatinine Ratio (UACR) [mg/g] at Week 24

    Timeframe: At baseline and week 24

  4. Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death

    Timeframe: Up to 51 months

  5. Time to first event of CV death, HFE, non-fatal myocardial infarction (MI) or non-fatal stroke (4-point Major adverse cardiovascular events (MACE))

    Timeframe: Up to 51 months

  6. Occurrences of all-cause hospitalisations (first and recurrent)

    Timeframe: Up to 51 months

  7. 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

    Timeframe: Up to 51 months

  8. Time to all-cause death

    Timeframe: Up to 51 months

  9. Time to CV death

    Timeframe: Up to 51 months

  10. Time to first HHF

    Timeframe: Up to 51 months

  11. Time to first event of new-onset HF or CV death

    Timeframe: Up to 51 months

  12. Occurrences of HHF (first and recurrent)

    Timeframe: Up to 51 months

  13. Absolute change from baseline in mean diastolic blood pressure (DBP) [mmHg] at Week 24

    Timeframe: At baseline and week 24

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Pinnacle Research Group, LLCAnniston, United StatesRecruiting
  • Eastern Shore Research GroupFairhope, United StatesRecruiting
  • Lakeview Clinical ResearchGuntersville, United StatesRecruiting
  • Arizona Clinical Trials - ChandlerChandler, United StatesRecruiting
  • Elite Clinical StudiesPhoenix, United StatesRecruiting
  • Clinical Research Institute of Arizona, LLCSun City West, United StatesRecruiting
  • Fiel Family & Sports MedicineTempe, United StatesRecruiting
  • Arizona Clinical TrialsTucson, United StatesRecruiting
  • Yuma Clinical TrialsYuma, United StatesRecruiting
  • National Heart InstituteBeverly Hills, United StatesRecruiting
  • Hope Clinical ResearchCanoga Park, United StatesRecruiting
  • John Muir Physician Network Clinical Research CenterConcord, United StatesRecruiting
  • Velocity Clinical Research-Huntington ParkHuntington Park, United StatesRecruiting
  • Velocity Clinical Research, San DiegoLa Mesa, United StatesRecruiting
  • First Valley Medical GroupLancaster, United StatesRecruiting
  • ARK Clinical ResearchLong Beach, United StatesRecruiting
  • Diabetes Associates Medical GroupOrange, United StatesRecruiting
  • Empire Clinical ResearchPomona, United StatesRecruiting
  • Velocity Clinical Research - San BernardinoSan Bernardino, United StatesRecruiting
  • Acclaim Clinical ResearchSan Diego, United StatesRecruiting
  • NorthBay Clinical Research, LLCSanta Rosa, United StatesRecruiting
  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, United StatesRecruiting
  • Blue Coast Research Center, LLCVista, United StatesRecruiting
  • Rocky Mountain Regional VA Medical CenterAurora, United StatesRecruiting
  • OptumCare Clinical Trials, LLCGolden, United StatesTerminated

And 1,122 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-521188-11-00
  • U1111-1319-9064
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (1)