Baxdrostat and Molecular Imaging of Adrenal Cytoreduction in Primary Aldosteronism

Sponsor
Queen Mary University of London
Study ID
NCT07800858
Status
Not Yet Recruiting

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Conditions

  • Primary Aldosteronism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Baxdrostat
    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.

Primary Outcome Measure

Change in total lesion uptake of [18F]-CETO in adrenal lesions [ Time Frame: Baseline to approximately 8 months ]

Central Contacts

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