BI 685509
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KG, Boehringer Ingelheim
Conditions
Diabetic NephropathiesHealthyHepatic InsufficiencyPortal hypertensionclinically significant portal hypertension (CSPH) in decompensated cirrhosis due to non-cholestatic liver diseasesystemic sclerosis
Phase 1
Investigation of Single Rising Doses of BI 685509
CompletedNCT02694354
Start: 2016-03-31End: 2016-04-30Updated: 2016-05-04
Safety and Tolerability of BI 685509 in Healthy Subjects
CompletedNCT03116906
Start: 2017-04-24End: 2018-06-01Updated: 2018-06-11
This Study Tests a New Medicine Called BI 685509 in Patients That Have Kidney Problems Because of Diabetes. The Study Tests How BI 685509 is Taken up in the Body and How Well it is Tolerated (Multiple Rising Doses)
CompletedNCT03165227
Start: 2017-10-17End: 2019-12-10Updated: 2020-01-13
This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated
CompletedNCT03259464
Start: 2017-09-04End: 2018-05-26Updated: 2018-07-05
A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems
CompletedNCT03842761
Start: 2019-03-06End: 2021-05-20Updated: 2021-06-10
Phase 2
A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease
CompletedNCT04750577
Start: 2021-04-27End: 2022-12-27Updated: 2024-07-23
A Phase II, randomised, placebo-controlled, double-blind, parallel-group, efficacy and safety study of at least 48 weeks of oral BI 685509 treatment in adults with progressive systemic sclerosis
Active, not recruitingCTIS2022-500332-11-00
Start: 2022-11-25Target: 68Updated: 2025-09-15
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
CompletedCTIS2023-504257-12-00
Start: 2022-07-28End: 2024-05-31Target: 62Updated: 2024-04-24
Randomised, double-blind, placebo-controlled and parallel group trial to investigate the effects of one dose (up-titration to a fixed dose regimen) of oral BI 685509 on portal hypertension after 8 weeks treatment in patients with clinically significant portal hypertension (CSPH) in decompensated cirrhosis after their first decompensation event, who are stabilized CTP 5-7
CompletedCTIS2023-506083-13-00
Start: 2024-02-16End: 2024-05-02Target: 22Updated: 2024-03-04