A Study To Assess Efficacy And Safety Of Baxdrostat In Participants With Primary Aldosteronism

Overview

About this study

This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction of Seated Blood Pressure (SBP) and unsuppression of Plasma Renin Activity (PRA) in approximately 180 participants ≥ 18 years of age with Primary Aldosteronism (PA), with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics.

Baxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks to based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and approximately 12 countries.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* Male or female participants must be ≥ 18 years of age
* Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.
* Participants willing and able to cease dosing of MRA orpotassium sparing diuretics per study requirement for participantstaking an MRA or potassium sparing diuretic at Screening.
* eGFR ≥ 45 mL/min/1.73m2 at Screening
* Serum potassium level ≥ 3.0 and \< 5.0 mmol/L at Screeningdetermined as per the central laboratory.
* Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation
* Mean seated SBP on AOBPM of ≥ 135 mmHg.

Exclusion Criteria:

- If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \> 170 mmHg or mean seated DBP ≥110 mmHg (on AOBPM).

If taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \> 160 mmHg or mean seated DBP ≥ 100 mmHg.

* Previous surgical intervention for an adrenal adenoma or have a planned adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.
* Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
* Serum sodium level \< 135 mmol/L at Screening, determined as per central laboratory.
* New York Heart Association functional HF class IV at Screening.
* Persistent atrial fibrillation.
* Treatment with any MRA or potassium-sparing diuretic within 2weeks prior to Randomisation.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

 

Eligibility last updated 08/12/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Irina Bancos

Contact us for the latest status

Contact information:

Vanessa Fell

(507) 266-6068

Fell.Vanessa@mayo.edu

More information

Publications

Publications are currently not available