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Primary AldosteronismEliXirNCT07800858

Baxdrostat and Molecular Imaging of Adrenal Cytoreduction in Primary Aldosteronism

A study testing baxdrostat in people with Primary Aldosteronism, run by Queen Mary University of London at 2 sites in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to find out whether treatment with baxdrostat changes aldosterone-producing activity in the adrenal glands of people with primary aldosteronism. The study will use specialised imaging to measure changes in the adrenal glands before and after treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Aldosteronism
What is being tested?
baxdrostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited Kingdom
Study dates
15 Sep 2026to 31 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 28Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom2 sites
  • Cambridge NHS Foundation Trust

    Cambridge

    Mark Gurnell, mg299@medschl.cam.ac.uk

  • Barts NHS Trust

    London

    William M Drake, w.m.drake@qmul.ac.uk

Other trials in United Kingdom

About this study

Official title: Effects of aLdosterone Inhibition by baXdrostat on Molecular Imaging of cytoReduction in Primary Aldosteronism and Hypertension

The goal of this clinical trial is to find out whether treatment with baxdrostat changes aldosterone-producing activity in the adrenal glands of people with primary aldosteronism. The study will use specialised imaging to measure changes in the adrenal glands before and after treatment.

Participants will receive baxdrostat for 24 weeks and will be followed for changes in their adrenal imaging, blood pressure and hormone levels. The study will also investigate whether changes caused by treatment continue after baxdrostat is stopped.

This is a single-group study, meaning that all participants receive baxdrostat and there is no placebo or comparison group.

Read the detailed description

Primary aldosteronism (PA) is a common cause of hypertension in which the adrenal glands produce excess aldosterone. In some participants, the source of excess aldosterone can be associated with a small adrenal nodule. Aldosterone synthase, encoded by the CYP11B2 gene, is the enzyme responsible for the final steps of aldosterone production.

Molecular imaging using [18F]-CETO PET-CT can be used to visualise aldosterone-producing tissue in the adrenal glands. This study will investigate whether treatment with the aldosterone synthase inhibitor baxdrostat produces a measurable reduction in aldosterone-producing activity on molecular imaging.

This is an open-label, single-arm experimental medicine study. All participants will receive baxdrostat and there is no placebo or control group. Participants will receive baxdrostat 2 mg once daily for 24 weeks. Molecular imaging will be performed before treatment and following the treatment period, allowing the adrenal imaging signal to be compared within the same participant before and after treatment.

The study is designed to investigate whether pharmacological inhibition of aldosterone synthase is associated with a quantitative reduction in the molecular imaging signal from aldosterone-producing adrenal tissue. It will also investigate whether changes in imaging are associated with changes in biochemical measures of aldosterone production and clinical measures such as blood pressure, and how long suppression of aldosterone production persists after treatment has ended.

[18F]-CETO PET-CT is performed following dexamethasone pretreatment to suppress background uptake and improve visualisation of aldosterone-producing adrenal tissue. The radioligand is administered intravenously and PET imaging is performed together with a low-dose anatomical CT scan. Imaging will be undertaken at St Bartholomew's Hospital or Cambridge University Hospitals.

Participants will undergo regular follow-up during and after treatment. Assessments include blood pressure measurements, blood tests for electrolytes and adrenal hormones, 24-hour urine collections for measurement of aldosterone-related biomarkers, and quality-of-life assessment. Follow-up after treatment will allow the investigators to assess whether biochemical and clinical effects of baxdrostat persist after treatment has stopped.

The study also provides an opportunity to investigate the relationship between molecular imaging findings and subsequent clinical management. Where participants subsequently undergo adrenalectomy or ablation as part of their usual clinical care, adrenal tissue may be used for exploratory laboratory analyses of aldosterone synthase expression and markers of apoptosis. Adrenalectomy or ablation is not a research intervention and is not required by the study.

The study uses a within-participant comparison of adrenal molecular imaging before and after baxdrostat treatment. Participants are stratified according to the characteristics of the largest [18F]-CETO-positive adrenal nodule, but there is no randomisation or allocation to different treatment groups.

The study is intended to improve understanding of the effects of aldosterone synthase inhibition on aldosterone-producing adrenal tissue. The findings may help clarify the relationship between biochemical suppression of aldosterone production and changes in adrenal molecular imaging, and may inform the development of future approaches to the treatment and investigation of primary aldosteronism.

Being tested
baxdrostat
Keywords
Primary aldosteronism, Aldosterone synthase, CYP11B2, [18F]-CETO, Baxdrostat, Molecular imaging, PET CT
Medical subject headings
Hyperaldosteronism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • baxdrostatDrug

    Baxdrostat 2 mg administered orally once daily for 24 weeks as an aldosterone synthase inhibitor. Treatment begins after the baseline [18F]-CETO PET-CT has confirmed eligibility for study treatment.

Study groups in NCT07800858
Study groupRoleWhat they receive
BaxdrostatExperimentalParticipants will receive baxdrostat 2 mg once daily for 24 weeks. All participants will receive the same intervention; there is no placebo or control group. Participants will undergo study assessments before, during and after treatment, including molecular imaging and biochemical assessments.
Receives: Drug: baxdrostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in total lesion uptake of [18F]-CETO in adrenal lesions

    Change, between pre- and post-baxdrostat PET-CT images, in total [18F]-CETO-positive lesion uptake, calculated by multiplying the volume (ml) of each lesion by its mean standardised uptake value (SUVmean) (unitless) and summing these values across all lesions. SUVmean is a dimensionless ratio of measured to injected radioactivity. This calculation generates a single reported value, expressed in SUV·ml, the conventional unit for this measurement. [Each lesion will be defined according to the 2025 European Association of Nuclear Medicine guideline.]

    Measured: Baseline to approximately 8 months

Secondary outcomes (15)
  1. Change in SUVmax between pre- and post-baxdrostat PET-CT images

    Change, between pre- and post-baxdrostat PET-CT images, in maximum standardised uptake value (SUVmax) (unitless) of individual [18F]-CETO-positive lesions. SUVmax is a dimensionless ratio of measured to administered radioactivity. Where more than one lesion is present, SUVmax will be measured separately for each lesion and the values averaged to provide a single participant-level result.

    Measured: Baseline to approximately 8 months

  2. Voxel level change between pre- and post-baxdrostat PET-CT images

    Voxel-level change in standardised uptake value (SUV) (unitless) between corresponding voxels across [18F]-CETO-positive lesions in pre- and post-baxdrostat PET-CT images. Pre- and post-treatment images will be registered to permit comparison of corresponding voxels, and the mean difference in SUV between paired voxels will be reported. SUV is a dimensionless ratio of measured to injected radioactivity.

    Measured: Baseline to approximately 8 months

  3. Change in the individual components of the primary endpoint: 1. Volume

    Change, between pre- and post-baxdrostat PET-CT images, in total volume (ml) of all [18F]-CETO-positive lesions. Where more than one lesion is present, individual lesion volumes will be summed to generate a single reported value.

    Measured: Baseline to approximately 8 months

  4. Change in the individual components of the primary endpoint - 2. mean SUV

    Change, between pre- and post-baxdrostat PET-CT images, in mean standardised uptake value (SUVmean) (unitless) across all [18F]-CETO-positive lesions. Where more than one lesion is present, a single overall SUVmean will be calculated across all lesions. SUVmean is a dimensionless ratio of measured to injected radioactivity.

    Measured: Baseline to approximately 8 months

  5. Change in whole-adrenal [18F]-CETO uptake

    Change, between pre- and post-baxdrostat PET-CT images, in whole adrenal gland uptake of [18F]-CETO, calculated as the total volume (ml) of adrenal tissue with SUV ≥4 multiplied by the mean standardised uptake value (SUVmean) (unitless) within that volume. This calculation generates a single reported value, expressed in SUV·ml, the conventional unit for this measurement. SUVmean is a dimensionless ratio of measured to injected radioactivity.

    Measured: Baseline to approximately 8 months

  6. Change in serum aldosterone 12 months after completion of baxdrostat treatment

    Change, between the end of baxdrostat treatment and 12 months after the end of treatment, in serum aldosterone (pmol/L).

    Measured: End of baxdrostat treatment (24 weeks) to 12 months after treatment.

  7. Change in plasma renin activity 12 months after completion of baxdrostat treatment

    Change, between the end of baxdrostat treatment and 12 months after the end of treatment, in plasma renin activity (nmol/L/hr).

    Measured: End of baxdrostat treatment (24 weeks) to 12 months after treatment

  8. Change in 24-hour urinary tetrahydroaldosterone 12 months after completion of baxdrostat treatment

    Change, between the end of baxdrostat treatment and 12 months after the end of treatment, in 24h urine tetrahydroaldosterone (micromoles per 24h).

    Measured: End of baxdrostat treatment (24 weeks) to 12 months after treatment

  9. Change in systolic blood pressure 12 months after completion of baxdrostat treatment

    Change, between the end of baxdrostat treatment (24 weeks) and 12 months after the end of treatment, in systolic blood pressure (mmHg).

    Measured: End of baxdrostat treatment (24 weeks) to 12 months after treatment

  10. Change in aldosterone-to-renin ratio 12 months after completion of baxdrostat treatment

    Change, between the end of baxdrostat treatment (24 weeks) and 12 months after the end of treatment, in the ratio of serum aldosterone (pmol/L) to plasma renin activity (nmol/L/hr). The single measure resulting from division of aldosterone by plasma renin activity, termed the aldosterone-to-renin ratio (ARR), is expressed in (pmol/L)/(nmol/L/hr).

    Measured: End of baxdrostat treatment (24 weeks) to 12 months after treatment

  11. Change in serum 11-deoxycorticosterone after 12 weeks of baxdrostat treatment

    Change, between baseline and 12 weeks of baxdrostat treatment, in serum 11-deoxycorticosterone (11-DOC) (pmol/L).

    Measured: Baseline to 12 weeks

  12. Change in serum 11-deoxycorticosterone after 24 weeks of baxdrostat treatment

    Change, between baseline and 24 weeks of baxdrostat treatment, in serum 11-deoxycorticosterone (11-DOC) (pmol/L).

    Measured: Baseline to 24 weeks

  13. Change in serum 11-deoxycorticosterone 2 months after completion of baxdrostat treatment

    Change, between baseline and 2 months after completion of baxdrostat treatment, in serum 11-deoxycorticosterone (11-DOC) (pmol/L).

    Measured: Baseline to 2 months after completion of baxdrostat treatment

  14. Change in serum 11-deoxycorticosterone 6 months after completion of baxdrostat treatment

    Change, between baseline and 6 months after completion of baxdrostat treatment, in serum 11-deoxycorticosterone (11-DOC) (pmol/L).

    Measured: Baseline to 6 months after completion of baxdrostat treatment

  15. Change in serum 11-deoxycorticosterone 12 months after completion of baxdrostat treatment

    Change, between baseline and 12 months after completion of baxdrostat treatment, in serum 11-deoxycorticosterone (11-DOC) (pmol/L).

    Measured: Baseline to 12 months after completion of baxdrostat treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-arm, open-label experimental medicine study. All participants will receive the same intervention, baxdrostat 2 mg once daily for 24 weeks. There is no randomisation, placebo or control group. Participants will be stratified according to the characteristics of the largest \[18F\]-CETO-positive adrenal nodule for study analysis.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07800858
Sponsor's protocol ID
371884
Acronym
EliXir
Status last verified
Aug 2026
First submitted
20 Aug 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing baxdrostat in people with Primary Aldosteronism, run by Queen Mary University of London at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aklima Khatun (0203 465 8577, aklima.khatun4@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in total lesion uptake of [18F]-CETO in adrenal lesions (time frame: Baseline to approximately 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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