Phase 2 Completed N=48 Randomized Double-blind Treatment

A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension

Uncontrolled Hypertension

Source: ClinicalTrials.gov NCT06336356 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2025

Primary outcomePrimary: Number of Participants With Serum Total Cortisol Level Before and After Adrenocorticotropic Hormone (ACTH) Stimulation Test — 0; 0; 26; 15 Participants

Summary

The main purpose of this study is to assess the serum free cortisol response after ACTH stimulation test at baseline and at Week 8 in participants with uncontrolled hypertension.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Serum Total Cortisol Level Before and After Adrenocorticotropic Hormone (ACTH) Stimulation Test	0; 0; 26; 15	—
SECONDARY Incidence of Abnormal Stimulated Cortisol at Week 8	0; 0; 26; 15	—
SECONDARY Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)	10; 6; 0; 0; 0; 0	—

Eligibility Criteria

Inclusion Criteria

Participants with mean seated systolic blood pressure (SBP) on automated office blood pressure measurement (AOBPM) greater than equal to (>=) 130 millimeter of mercury (mmHg) and less than ( =130 mmHg and =1 antihypertensive medication (at least one should be a diuretic), for at least 4 weeks prior to screening.
Participants must have an estimated glomerular filtration rate (eGFR) >=45 milliliter per minute (mL/min)/1.73-meter square (m^²) at screening.
Participants must have a serum potassium+ (K+) level >=3.5 and =110 mmHg at randomization.
Prior treatment (within the 4 weeks before screening) with angiotensin receptor Blocker (ARBs) and angiotensin converting enzyme inhibitor (ACEIs) (both taken simultaneously).
Serum sodium (Na+) level 10.0% (86 mmol/mol) at screening.
Fridericia's corrected QT (QTcF) value > 470 milliseconds (ms) at screening, unless having a pacemaker.
Heart rate 110 beats/min in a resting position, as per vital signs assessment.

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Data sourced from ClinicalTrials.gov (NCT06336356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.