At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Vicadrostat (drug), Empagliflozin (drug), Placebo matching Vicadrostat (drug)
- How long the study runs
- Study runs about 53 months (dates as stated)
- About the drug or intervention
- Vicadrostat — drug: Vicadrostat · Empagliflozin — drug: Empagliflozin · Placebo matching Vicadrostat — drug: Placebo matching Vicadrostat
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 11,800
- Started
- 2025-07-22
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for diabetes mellitus, type 2
- • Phase3 - 11,800 participants
- • This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with diabetes mellitus, type 2
Where?
- • Birmingham - FutureMeds - Birmingham
- • Blackburn - Royal Blackburn Teaching Hospital
- • Bournemouth - Royal Bournemouth Hospital
- • Bradford - Bradford Royal Infirmary
- • +29 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Who cannot take part
- ✗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...
- ✗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
See the full criteria
Where Is This Study? (33 UK sites)
FutureMeds - Birmingham
Birmingham B21 9RY, United Kingdom
Royal Blackburn Teaching Hospital
Blackburn BB2 3HH, United Kingdom
Royal Bournemouth Hospital
Bournemouth BH7 7DW, United Kingdom
Bradford Royal Infirmary
Bradford BD9 6RJ, United Kingdom
Coniston Medical Practice
Bristol BS34 5TF, United Kingdom
Yatton Surgery
Bristol BS49 4ER, United Kingdom
FutureMeds - Liverpool
Bromborough CH62 6EE, United Kingdom
St Richard's Hospital
Chichester PO19 6SE, United Kingdom
Queen Alexandra Hospital
Cosham PO6 3LY, United Kingdom
Darlington Memorial Hospital
Darlington DL3 6HX, United Kingdom
Royal Derby Hospital
Derby DE22 3NE, United Kingdom
Ninewells Hospital & Medical School
Dundee DD1 9SY, United Kingdom
The Falmouth Health Centre Practice
Falmouth TR11 2LH, United Kingdom
The Garth Surgery
Guisborough TS14 7DJ, United Kingdom
Ipswich Hospital (UK)
Ipswich IP4 5PD, United Kingdom
Victoria Hospital
Kirkcaldy KY2 5AH, United Kingdom
Royal Lancaster Infirmary
Lancaster LA1 4RP, United Kingdom
Pinfold Surgery
Leeds LS26 9AA, United Kingdom
Lincoln County Hospital
Lincoln LN2 5QY, United Kingdom
William Harvey Research Limited
London EC1M 6BQ, United Kingdom
FutureMeds - London
London NW10 2PB, United Kingdom
Manchester Royal Infirmary
Manchester M13 0EW, United Kingdom
Wythenshawe Hospital
Manchester M23 9LT, United Kingdom
North Manchester General Hospital
Manchester M8 5RB, United Kingdom
Linthorpe Surgery
Middlesbrough TS5 6HA, United Kingdom
FutureMeds - Newcastle
Newcastle upon Tyne NE6 1SG, United Kingdom
Mayford House Surgery
Northallerton DL7 8AW, United Kingdom
Norfolk and Norwich University Hospital
Norwich NR4 7UQ, United Kingdom
Moorgreen Hospital
Southampton SO30 3JB, United Kingdom
Swansea University Medical School
Swansea SA2 8PP, United Kingdom
Trowbridge Health Centre
Trowbridge BA14 8LW, United Kingdom
Weymouth Research Hub
Weymouth DT4 0QE, United Kingdom
Woodthorpe Surgery
York YO24 2RQ, United Kingdom
How to Get in Touch
Boehringer Ingelheim
Sponsor contactCONTACT