1378-0041

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1012264

• Contact name

  Medical Information

• Contact email

  medinfo.bra@boehringer-ingelheim.com

• Sponsor organisation

  Boehringer Ingelheim Limited

• Clinicaltrials.gov Identifier

  NCT07064473

• Research 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 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.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  25/LO/0425

• Date of REC Opinion

  22 Jul 2025

• REC opinion

  Further Information Favourable Opinion