Vicadrostat EASi-KIDNEY Trial Discontinued for Lack of Benefit in CKD

Boehringer Ingelheim has discontinued the phase 3 EASi-KIDNEY trial evaluating vicadrostat (BI 690517) in combination with empagliflozin (Jardiance) for chronic kidney disease (CKD), following a recommendation from an independent Data Monitoring Committee (DMC).¹

The Company reported accumulating trial data did not support a meaningful expectation of clinical benefit on the primary composite endpoint versus empagliflozin alone.¹ EASi-KIDNEY was conducted in partnership with the University of Oxford as 1 of 4 phase 3 studies within the broader EASi program.¹

“While this outcome is disappointing, it does not diminish the significant unmet medical need faced by these patients,“ Will Herrington, Chief Investigator EASi-KIDNEY at the University of Oxford, said in a statement. “We sincerely thank the patients, investigators and study teams who participated in and supported this trial.”

The discontinuation applies solely to EASi-KIDNEY. Separate DMCs reviewing the remaining phase 3 studies in the EASi program independently recommended those trials continue unchanged.¹ Empagliflozin's established benefit-risk profile, supported by extensive clinical study data and years of real-world use, is not affected by the EASi-KIDNEY findings.¹

Vicadrostat and Empagliflozin in EASi-KIDNEY Trial Design

EASi-KIDNEY evaluated vicadrostat, an investigational aldosterone synthase inhibitor (ASi), added to empagliflozin, an SGLT2 inhibitor marketed since 2014, against empagliflozin alone in adults with CKD.¹ The trial was designed to determine whether the combination could slow kidney disease progression and reduce cardiovascular risk beyond what empagliflozin provides on its own.¹

Boehringer Ingelheim based its decision on a comprehensive benefit-risk assessment of accumulating data reviewed by the independent DMC.¹ The Company concluded the available data did not support a meaningful expectation of clinical benefit for the EASi-KIDNEY CKD population on the primary composite endpoint.¹ Analyses of the trial data remain ongoing, and the Company said its conclusion reflects the totality of information available to date.¹

EASi-KIDNEY Discontinuation and Status of the EASi Program

Boehringer Ingelheim characterized the discontinuation as driven by a lack of expected clinical benefit rather than a new safety signal.¹ Health authorities, investigators, and study sites are being informed, and trial participants are being contacted by their investigators and given guidance on their study treatment and the trial's closure.¹

EASi-KIDNEY was 1 of 4 phase 3 trials in the broader EASi program, which also includes EASi-HF Reduced and EASi-HF Preserved in heart failure and EASi-PROTKT in type 2 diabetes with hypertension and established cardiovascular disease.² Their respective DMCs recommended these trials continue without modification following separate reviews of currently available data.¹

Vicadrostat remains investigational and has not received marketing authorization in any country, and the EASi-KIDNEY results do not change empagliflozin's approved indications.¹

“Millions of people worldwide live with interconnected cardiovascular, renal, and metabolic conditions, and the need for better treatment options remains urgent”, said Lykke Hinsch Gylvin, Chief Medical Officer and Head of Global Medicine at Boehringer Ingelheim. “Our commitment to advancing science in this area remains unchanged and we will continue to pursue new approaches with the same scientific rigor, transparency, and focus on patient safety that guided this decision.”

Boehringer Ingelheim did not name specific data from the primary composite endpoint in its announcement. The Company said further analyses of EASi-KIDNEY are ongoing, and the discontinuation reflects the totality of information available at this stage of the trial.¹

References

1. Boehringer Ingelheim. Boehringer provides update on EASi-KIDNEY trial. Published September 15, 2026. Accessed September 15, 2026. https://www.boehringer-ingelheim.com/human-health/boehringer-provides-update-easi-kidney-trial

2. ClinicalTrials.gov. A study to test vicadrostat (BI 690517) taken together with empagliflozin in people with symptomatic chronic heart failure (EASi-HF Reduced). Identifier: NCT06935370. Accessed September 15, 2026. https://clinicaltrials.gov/study/NCT06935370

3. ClinicalTrials.gov. The studies of heart & kidney protection with BI 690517 in combination with empagliflozin (EASi-KIDNEY). Identifier: NCT06531824. Accessed September 15, 2026. https://clinicaltrials.gov/study/NCT06531824