1366-0029 Study of BI 685509 in patients with NASH
Research type
Research Study
Full title
Randomised, open-label and parallel group trial to investigate the effects of oral BI 685509 alone or in combination with empagliflozin on portal hypertension after 8 weeks treatment in patients with clinically significant portal hypertension (CSPH) in compensated cirrhosis
IRAS ID
1004934
Contact name
Medical Information
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd.
Eudract number
2021-005171-40
Clinicaltrials.gov Identifier
Research summary
This study is open to adults with liver cirrhosis caused by hepatitis B, hepatitis C or non- alcoholic steatohepatitis (NASH). People can join this study if they have high blood pressure in the portal vein (main vessel going to the liver).
The purpose of this study is to find out whether a medicine called BI 685509 taken alone or in combination with a medicine called empagliflozin helps people with this condition.
Participants take BI 685509 as tablets twice a day for 8 weeks. Half of the participants with NASH who also have type 2 diabetes take empagliflozin as tablets once a day in addition to BI 685509.
Participants are in the study for about 3 months. During this time, they visit the study site about 10 times. At 2 of the visits, the doctors check the pressure in a liver vein to see whether the treatment works. This is done with a catheter (a long thin tube) and gives information about the pressure in the portal vein.
The doctors also regularly check participants’ health and take note of any unwanted effects.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0077
Date of REC Opinion
19 May 2022
REC opinion
Further Information Favourable Opinion