BI 690517
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Universitair Medisch Centrum Groningen, Boehringer Ingelheim
Conditions
Chronic kidney diseaseDiabetic NephropathiesHealthyHeart failureHeart failure (HF)Kidney Disease, ChronicLiver DiseasesType 2 diabetes
Phase 1
Single Rising Dose Study of BI 690517 in Healthy Volunteers
CompletedNCT02891148
Start: 2016-09-29End: 2016-12-12Updated: 2024-09-20
This Study Tests How Different Doses of BI 690517 Are Taken up in the Body of Healthy Men. The Study Also Looks at How Food Influences the Amount of BI 690517 in the Blood
CompletedNCT03100916
Start: 2017-05-05End: 2017-11-24Updated: 2024-09-20
This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 3 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated
CompletedNCT03165240
Start: 2017-10-05End: 2020-05-07Updated: 2024-09-20
This Study is Done in Healthy Chinese and Japanese Volunteers; it Looks at How BI 690517 is Taken up in the Body and How Well it is Tolerated
CompletedNCT03206632
Start: 2017-07-17End: 2017-10-13Updated: 2024-09-20
A Study in Healthy Japanese Men to Test How Different Doses of BI 690517 Are Taken Up in the Body and How Well They Are Tolerated
CompletedNCT03608072
Start: 2018-08-06End: 2019-01-31Updated: 2024-11-25
A Study in Healthy Men to Test How BI 690517 is Taken up and Handled by the Body
CompletedNCT05515588
Start: 2022-09-19End: 2022-11-17Updated: 2024-09-20
A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver Problems
CompletedNCT05731908
Start: 2023-02-21End: 2023-04-13Updated: 2024-09-20
Phase 2
A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease
CompletedNCT05182840
Start: 2022-01-11End: 2023-07-10Updated: 2024-10-22
A Phase II randomised, double-blind, parallel-group, multicentre, international trial to investigate the safety and efficacy of vicadrostat and empagliflozin administered with simultaneous vs staggered initiation in participants with chronic kidney disease at risk of kidney disease progression
RecruitingCTIS2024-518457-42-00
Start: 2025-08-28Target: 100Updated: 2025-08-11
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects in Patients with Heart Failure or Cardiovascular Disease and Chronic Kidney Disease (COMPARE-VS)
Not yet recruitingCTIS2025-523743-35-00
Target: 100Updated: 2026-03-23
Phase 3
EASi-KIDNEY - Studies of Heart & Kidney Protection with BI 690517 in combination with empagliflozin: A multicenter, international, randomized, double-blind, placebo-controlled clinical trial of the aldosterone synthase inhibitor BI 690517 in combination with empagliflozin in patients with chronic kidney disease
RecruitingCTIS2024-511025-63-00
Start: 2024-10-21Target: 2500Updated: 2026-01-14
EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
RecruitingNCT06531824
Start: 2024-08-13End: 2028-08-30Target: 11000Updated: 2026-04-02
EASi-HF Preserved – 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 symptomatic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) ≥40%
RecruitingCTIS2023-509706-30-00
Start: 2024-10-18Target: 2461Updated: 2026-01-12
EASi-HF Reduced – 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 symptomatic chronic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) < 40%
RecruitingCTIS2024-519525-38-00
Start: 2025-08-22Target: 1539Updated: 2026-01-12
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
RecruitingCTIS2025-521188-11-00
Start: 2025-10-15Target: 4576Updated: 2026-01-27