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Study identifier: NCT07064473 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Diabetes Mellitus, Type 2 · Hypertension · Cardiovascular Diseases  ·  Sponsor: Boehringer Ingelheim

PhasePhase 3
Planned participants11800
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Boehringer Ingelheim  ·  1-800-243-0127  ·  clintriage.rdg@boehringer-ingelheim.com

Always discuss trial participation with your own doctor first.

Locations (1149)

Pinnacle Research Group, LLCAnniston, Alabama, United StatesRecruiting
Eastern Shore Research GroupFairhope, Alabama, United StatesRecruiting
Lakeview Clinical ResearchGuntersville, Alabama, United StatesRecruiting
Arizona Clinical Trials - ChandlerChandler, Arizona, United StatesRecruiting
Elite Clinical StudiesPhoenix, Arizona, United StatesRecruiting
Clinical Research Institute of Arizona, LLCSun City West, Arizona, United StatesRecruiting
Fiel Family & Sports MedicineTempe, Arizona, United StatesRecruiting
Arizona Clinical TrialsTucson, Arizona, United StatesRecruiting
Yuma Clinical TrialsYuma, Arizona, United StatesRecruiting
National Heart InstituteBeverly Hills, California, United StatesRecruiting
Hope Clinical ResearchCanoga Park, California, United StatesRecruiting
John Muir Physician Network Clinical Research CenterConcord, California, United StatesRecruiting

+ 1137 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07064473