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

Conditions

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vicadrostat — DRUG
  Vicadrostat
• Empagliflozin — DRUG
  Empagliflozin
• Placebo matching Vicadrostat — DRUG
  Placebo matching Vicadrostat

Study Details

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.

Key Dates

Start date

Jul 22, 2025

Status verified

Jun 2026

Primary completion

Dec 14, 2029

Completion

Dec 21, 2029

Study Design

Enrollment

11,800 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Vicadrostat + empagliflozin treatment arm
• Active Comparator: Vicadrostat-placebo + empagliflozin treatment arm

Primary Outcome Measure

Time to first event of cardiovascular (CV) death or heart failure event (HFE) [ Time Frame: Up to 51 months ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (216)

Find similar trials in Anniston, AL

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