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Completed

NCT Number: NCT06336356

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

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.

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Key information

Conditions

Uncontrolled Hypertension

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Phoenix, Arizona, United States

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About this study

This is a placebo-controlled study to evaluate cortisol reserve after ACTH stimulation test following treatment with 2 milligrams (mg) baxdrostat versus placebo.

The study consists of 3 period:

  • 4-week screening period.
  • An 8-week double-blind treatment period.
  • A safety follow-up 2 weeks after last dose.

Participants will be randomized in a 2:1 ratio to one of 2 treatment arms:

  • Baxdrostat
  • Placebo

Participants will receive either baxdrostat or placebo.

The overall study duration will be up to 16 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (<) 170 mmHg at screening.
  • Participants with mean seated SBP on AOBPM of >=130 mmHg and < 170 mmHg at randomization.
  • Participants must have a stable regimen of >=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 < 5.0 millimole per liter (mmol/L) at screening.

Exclusion criteria

  • Mean seated diastolic blood pressure (DBP) on AOBPM >=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 < 135 millimole per liter (mmol/L) at screening, determined as per central laboratory.
  • New York heart association functional heart failure (HF) Class IV at screening.
  • Planned percutaneous coronary intervention/coronary artery bypass grafting or percutaneous coronary intervention/coronary artery bypass grafting done within 6 months prior to screening.
  • Uncontrolled diabetes with glycated haemoglobin (HbA1c) > 10.0% (86 mmol/mol) at screening.
  • Fridericia's corrected QT (QTcF) value > 470 milliseconds (ms) at screening, unless having a pacemaker.
  • Heart rate < 45 or > 110 beats/min in a resting position, as per vital signs assessment.

Treatment and study plan

baxdrostat

Drug

Baxdrostat will be administered orally once daily.

Other names: RO6836191,, CIN-107

Placebo

Drug

Placebo will be administered orally once daily.

Primary outcomes

  1. Number of Participants With Serum Total Cortisol Level Before and After Adrenocorticotropic Hormone (ACTH) Stimulation Test

    Time frame: Week 8

    The primary endpoint is individual participant's cortisol levels at each timepoint. Number of participants with normal stimulated serum total cortisol level at baseline are presented here.

    Characterisation of the serum total cortisol levels before and after ACTH stimulation test. An ACTH stimulation test using 250 μg ACTH was performed at baseline and Week 8 (End of Treatment), with serum cortisol level measured before and after ACTH stimulation test.

    Normal cortisol levels are defined as at least 18 μg/dL when measured 60 minutes (±10 minutes) after stimulation. If the Week 8 results show abnormal levels, a repeat test is conducted. In this repeat test, cortisol is considered abnormal only if both of the following conditions are met: the level is less than 14.8 μg/dL at 30 minutes (± 5 minutes) and less than 18 μg/dL at 60 minutes (±10 minutes).

Secondary outcomes

  1. Incidence of Abnormal Stimulated Cortisol at Week 8

    Time frame: Week 8

    The secondary endpoint is the incidence of abnormal stimulated cortisol after ACTH stimulation test at Week 8. Incidence of normal stimulated serum total cortisol level at baseline are presented.

    Normal cortisol levels are defined as at least 18 μg/dL when measured 60 minutes (±10 minutes) after stimulation. If the Week 8 results show abnormal levels, a repeat test is conducted. In this repeat test, cortisol is considered abnormal only if both of the following conditions are met: the level is less than 14.8 μg/dL at 30 minutes (± 5 minutes) and less than 18 μg/dL at 60 minutes (±10 minutes). Participants who had abnormal cortisol levels at the start of the study (baseline) were not included in this analysis.

  2. Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)

    Time frame: From Day 1 up to Week 8 or Safety follow-up (14 days post last dose), which ever comes first (up to 10 weeks)

    Safety and tolerability of baxdrostat as compared with placebo was assessed. For this clinical study, AESIs include the following: hyperkalaemia, hyponatraemia and hypotension events that require medical intervention.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone Stimulation Test Following Treatment With Baxdrostat for 8 Weeks in Participants With Uncontrolled Hypertension

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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