A trial to learn how safe baxdrostat is and how well it works in adults with primary aldosteronism

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

19 Sep 2025 → ongoing

Decision date (initial)

2025-08-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AstraZeneca AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Therapy, Others, Pharmacodynamic

1. To assess the effect of baxdrostat versus placebo on seated SBP at Week 8

2. To assess the effect of baxdrostat versus placebo on achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) at week 8

Secondary objectives 6

1. To assess the effect of baxdrostat versus placebo on the percent change in DRC 8 weeks after the start of randomised withdrawal (RWD)
2. To assess the effect of baxdrostat versus placebo on seated SBP after 8 weeks after the start of RWD
3. To assess the effect of baxdrostat versus placebo on achieving normalisation of the Renin Angiotensin Aldosterone System (RAAS) at week 8, in participants with dysregulated RAAS at baseline.
4. To assess the effect of baxdrostat versus placebo on achieving serum potassium ≥ 3.7 mmol/L without potassium supplementation at Week 8 in participants with serum potassium < 3.7 mmol/L or potassium supplementation at baseline
5. To assess the effect of baxdrostat versus placebo on achieving 24-hour urine aldosterone < 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline
6. To assess the effect of baxdrostat versus placebo on 24-hour urine albumin at Week 8

Conditions and MedDRA coding

Primary Aldosteronism defined by excess aldosterone secretion

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration, Pharmaceuticals And Medical Devices Agency

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Male or female participants must be ≥ 18 years of age
2. Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.
3. Participants willing and able to cease dosing of MRA or potassium sparing diuretics per study requirement for participants taking an MRA or potassium sparing diuretic at Screening.
4. eGFR ≥ 45 mL/min/1.73m2 at Screening
5. Serum potassium level ≥ 3.0 and < 5.0 mmol/L at Screening determined as per the central laboratory.
6. Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation
7. Mean seated SBP on AOBPM of ≥ 135 mmHg and ≤ 170 mmHg and mean DBP of ≤ 105 mmHg.
8. Serum potassium (local lab) > 3.0 mmol/L at randomization.

Exclusion criteria 7

1. If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP > 170 mmHg or mean seated DBP ≥105 mmHg (on AOBPM). If taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP > 160 mmHg or mean seated DBP ≥ 100 mmHg.
2. Previous surgical intervention for an adrenal adenoma or have a planned adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.
3. Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing’s syndrome, aortic coarctation.
4. Serum sodium level < 135 mmol/L at Screening, determined as per central laboratory.
5. New York Heart Association functional HF class IV at Screening.
6. Persistent atrial fibrillation.
7. Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomisation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. Change from baseline in seated SBP at Week 8
2. 2. Normalization of the Renin Angiotensin Aldosterone system (RAAS) at Week 8

Secondary endpoints 6

1. Percent change from RWD baseline (Week 44) in DRC at Week 52
2. Change from RWD baseline (Week 44) in seated SBP at Week 52
3. Achieving normalisation of the Renin Angiotensin Aldosterone System (RAAS) at week 8
4. Achieving serum potassium ≥ 3.7 mmol/L without potassium supplementation at Week 8 in participants with serum potassium < 3.7 mmol/L or potassium supplementation at baseline
5. Achieving 24-hour urine aldosterone < 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline
6. Percent change from baseline in 24-hour urine albumin at Week 8

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

4 EU/EEA countries · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 30 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications