Can a pill quiet the adrenal Glands' hormone overdrive?

NCT ID NCT07800858

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial asks whether baxdrostat, a daily pill that blocks an enzyme involved in aldosterone production, can reduce the overactive hormone-making spots in the adrenal glands of people with primary aldosteronism. Researchers will use specialized PET-CT scans to measure changes in those spots before and after 24 weeks of treatment. All 30 participants receive baxdrostat, and the study also tracks blood pressure, hormone levels, and whether any changes persist after stopping the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
baxdrostat, an aldosterone synthase inhibitor taken as a 2 mg oral tablet daily for 24 weeks
What this could lead to
If baxdrostat lowers aldosterone activity in the adrenal glands, it could become a targeted treatment for primary aldosteronism, potentially reducing the need for surgery or lifelong blood pressure drugs.
What could go wrong
This is a small, single-group study with no placebo, so results may not apply broadly. The drug may not change imaging or hormone levels as hoped, and side effects from aldosterone inhibition are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * Male or female * Age \> 18 years at time of signing informed consent. * Diagnosed with Primary Aldosteronism (PA) according to Endocrine Society guidelines * Presence of one or more adrenal nodules, (diameter 0.5-2.5 cm) on CT, PET-CT, or MRI, with characteristics (e.g. washout) of adenomas * Suppressed cortisol after overnight dexamethasone * Willing to take baxdrostat for 6 months and attend follow-up visits * Willing to undergo PET-CT imaging * Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening. * Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L * Negative pregnancy test for female participants of childbearing potential * Able and willing to provide written consent Exclusion criteria * \<18 years of age * Current or prior treatment (within 1 month before screening) with angiotensin-receptor blockers in combination with ACEIs. * Serum sodium level \< 135 mmol/L at screening, determined as per central laboratory. * The following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation. * New York Heart Association functional Heart Failure class IV at Screening. * Known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease. * Known severe hepatic impairment. * Uncontrolled diabetes with HbA1c \> 10.0% (86 mmol/mol) at screening. * Participants suspected to have severe cardiac hypertrophy. * Treatment with any MRAs or potassium-sparing diuretics within 1 month prior to screening. * Treatment with potassium binders within 1 month prior to screening. * Is expected to receive or is receiving any of the exclusionary drugs such as strong inducers of cytochrome P450 (CYP) 3A, chronic (taken more than 3 times a week for more than 3 months) use of NSAIDs, MRAs or chronic use of systemic steroids. * Treatment with K+ supplements is not prohibited but the use should be continuously assessed throughout the trial. * Inability or unwillingness to undergo PET-CT imaging * Significant comorbidities that would interfere with participation * Pregnancy or breastfeeding * Unable to give informed consent

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Barts NHS Trust

    London, United Kingdom

  • Cambridge NHS Foundation Trust

    Cambridge, United Kingdom

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