Baxdrostat and Molecular Imaging of Adrenal Cytoreduction in Primary Aldosteronism

NCT07800858 | Not Yet Recruiting

• 1 other identifier: 371884
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Primary Aldosteronism

Keywords

Primary aldosteronism; Aldosterone synthase; CYP11B2; [18F]-CETO; Baxdrostat; Molecular imaging; PET CT

Outcome Measures

Primary Outcomes (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. \[Each lesion will be defined according to the 2025 European Association of Nuclear Medicine guideline.\]

  Baseline to approximately 8 months

Secondary Outcomes (15)

• Change in SUVmax between pre- and post-baxdrostat PET-CT images

  Baseline to approximately 8 months

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

  Baseline to approximately 8 months

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

  Baseline to approximately 8 months

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

  Baseline to approximately 8 months

• Change in whole-adrenal [18F]-CETO uptake

  Baseline to approximately 8 months

Study Arms (1)

Baxdrostat

EXPERIMENTAL

Participants 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.

Drug: baxdrostat

Interventions

baxdrostat DRUG

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.

Baxdrostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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.
• 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

Sponsors & Collaborators

• Queen Mary University of London: lead
• AstraZeneca: collaborator

Study Sites (2)

Cambridge NHS Foundation Trust

Cambridge, United Kingdom

Location

Barts NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Morris J Brown, FMedSci, FRS

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aklima Khatun

CONTACT

0203 465 8577; aklima.khatun4@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: September 2, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)