Pharmacodynamics of vicadrostat for aldosterone synthase inhibition in patients with CKD
Authors' conclusion
Vicadrostat, with or without background empagliflozin, selectively suppressed aldosterone over cortisol. These findings will be explored in a phase 3 trial program.
Study context
- Population
- Participants with albuminuric CKD (with or without T2D), after 8-week run-in on empagliflozin 10 mg or placebo plus renin-angiotensin system inhibitors410 completed treatment, analysed
- Participants
- 586 participants
- Comparison
- Vicadrostat vs placebo, with or without empagliflozin
Methodological detailsdouble-blind, placebo-controlled, phase 2
- Double-blind
- Placebo-controlled
- Phase 2
Primary result
As reported in the abstract
Plasma corticosteroids: geometric mean change in aldosterone · week 14
Vicadrostat 20 mg + empagliflozin
−49.5%
geometric mean change · 95% CI −68.7–-18.5
Vicadrostat 20 mg without empagliflozin
−52.1%
geometric mean change · CI −70.7–-21.6
Further findings
Percent
Vicadrostat 20 mg + empagliflozin
222.8%(95% CI 103.2–412.7)
Vicadrostat 20 mg without empagliflozin
231.5%(95% CI 106.4–432.2)
Percent
Vicadrostat 20 mg + empagliflozin
112.5%(95% CI 36.0–231.9)
Vicadrostat 20 mg without empagliflozin
121.0%(95% CI 40.0–249.0)
- Increases in mean plasma corticosterone, 11-deoxycorticosterone and 11-deoxycortisol
Post-treatment follow-up · 4 weeks post-treatment
- Aldosterone suppression sustained to 4 weeks post-treatment; precursor levels normalized within 1 week of cessation
Original publication
Pharmacodynamics of vicadrostat for aldosterone synthase inhibition in patients with CKD. Eur J Endocrinol. Published 23 December 2025. doi:10.
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