A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism

NCT07007793 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: D6974C00001
• Study Type: interventional
• Target: 250
• Locations: 12 countries
• Sites: 89

Brief Summary

This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction of Seated Blood Pressure (SBP) and achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) in approximately 180 participants ≥ 18 years of age with Primary Aldosteronism (PA), with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. Baxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and 12 countries.

Conditions

Primary Hyperaldosteronism

Keywords

Primary hyperaldosteronism; Primary aldosteronism; PA; Baxdrostat; CIN-107; Aldosterone

Outcome Measures

Primary Outcomes (2)

• Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8

  To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 8

  At week 8

• Achieving normalization of the Renin Angiotensin Aldosterone system (RAAS) at week 8

  To assess the effect of baxdrostat versus placebo on achieving normalization of the Renin Angiotensin Aldosterone system (RAAS) at week 8, in participants with dysregulated RAAS at baseline

  At week 8

Secondary Outcomes (6)

• Change from Randomised withdrawal (RWD) baseline (Week 44) in seated Systolic Blood Pressure (SBP) at Week 52

  At week 52

• Percent change from RWD baseline (Week 44) in Plasma Renin Activity (PRA) at Week 52

  At week 52

• 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

  At week 8

• Percent change from baseline in PRA at Week 8

  At week 8

• Achieving 24-hour urine aldosterone < 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline

  At week 8

Other Outcomes (1)

• Number of participants with adverse events (AEs)

  up to 54 weeks

Study Arms (2)

Baxdrostat

EXPERIMENTAL

Baxdrostat administered orally, once daily (QD).

Drug: Baxdrostat

Placebo

PLACEBO COMPARATOR

Matching placebo administered orally, once daily (QD).

Drug: Placebo

Interventions

Baxdrostat DRUG

Baxdrostat tablet administered orally, once daily (QD).

Also known as: CIN-107

Baxdrostat

Placebo DRUG

Placebo tablet matching baxdrostat, administered orally, once daily (QD).

Placebo

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 participants must be ≥ 18 years of age
• Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.
• 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.
• eGFR ≥ 45 mL/min/1.73m2 at Screening
• Serum potassium level ≥ 3.0 and \< 5.0 mmol/L at Screening determined as per the central laboratory.
• Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation
• Mean seated SBP on AOBPM of ≥ 135 mmHg and ≤ 170 mmHg and mean DBP of
• ≤ 105 mmHg.
• Serum potassium (local lab) \> 3.0 mmol/L at randomization.

You may not qualify if:

• \- 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.
• 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.
• 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.
• Serum sodium level \< 135 mmol/L at Screening, determined as per central laboratory.
• New York Heart Association functional HF class IV at Screening.
• Persistent atrial fibrillation.
• Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomisation.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (89)

Research Site

Los Angeles, California, 90048, United States

NOT YET RECRUITING

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San Francisco, California, 94110, United States

NOT YET RECRUITING

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Farmington, Connecticut, 06030, United States

NOT YET RECRUITING

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Chicago, Illinois, 60611, United States

NOT YET RECRUITING

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Springfield, Illinois, 62702, United States

RECRUITING

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Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

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Boston, Massachusetts, 02111, United States

RECRUITING

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Boston, Massachusetts, 02115, United States

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Ann Arbor, Michigan, 48109, United States

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Rochester, Minnesota, 55902, United States

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Olive Branch, Mississippi, 38654, United States

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Kansas City, Missouri, 64151, United States

WITHDRAWN

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New York, New York, 10065, United States

NOT YET RECRUITING

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Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

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Columbus, Ohio, 43210, United States

RECRUITING

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Portland, Oregon, 97239, United States

WITHDRAWN

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Bethlehem, Pennsylvania, 18017, United States

RECRUITING

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Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

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Columbia, South Carolina, 29203, United States

RECRUITING

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Brownsville, Texas, 78526, United States

WITHDRAWN

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Dallas, Texas, 75390, United States

RECRUITING

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Brisbane, 4102, Australia

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Clayton, 3168, Australia

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Perth, 6000, Australia

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Calgary, Alberta, T2T 5C7, Canada

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Ottawa, Ontario, K1H 7W9, Canada

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Toronto, Ontario, M4G 3E8, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Beijing, 100034, China

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Beijing, 100044, China

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Beijing, 100191, China

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Changsha, 430033, China

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Chengdu, 610041, China

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Chengdu, 610500, China

WITHDRAWN

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Chongqing, 400042, China

RECRUITING

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Nanjing, 2100008, China

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Shanghai, 200025, China

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Tianjin, 300050, China

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Wuhan, 430030, China

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Wuhan, 430060, China

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Xianyang, 750004, China

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Amiens, 80054, France

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Bois-Guillaume, 76230, France

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Bordeaux, 33076, France

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Lille, 59037, France

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Marseille, 13005, France

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Paris, 75018, France

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Paris, 75908, France

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Berlin, 12203, Germany

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Düsseldorf, 40225, Germany

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Kaiserslautern, 67655, Germany

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München, 80336, Germany

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Reinfeld (Holstein), 23858, Germany

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Würzburg, 97080, Germany

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Belagavi, 590010, India

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Delhi, 110029, India

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Hyderabad, 500012, India

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Kolkata, 700020, India

RECRUITING

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Mumbai, 400008, India

NOT YET RECRUITING

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Mumbai, 400012, India

RECRUITING

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Bologna, 40138, Italy

RECRUITING

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Brescia, 25123, Italy

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Florence, 50134, Italy

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Milan, 20149, Italy

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Milan, 20162, Italy

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Torino, 10126, Italy

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Kawasaki-shi, 216-8511, Japan

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Kodaira-shi, 187-8510, Japan

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Minatoku, 108-8329, Japan

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Ōta-ku, 143-8541, Japan

RECRUITING

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Shinjuku-ku, 162-8666, Japan

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Yokohama, 230-8765, Japan

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Yufu-shi, 879-5593, Japan

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Barcelona, 08036, Spain

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Madrid, 28034, Spain

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Madrid, 28040, Spain

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Madrid, 28046, Spain

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Seville, 41013, Spain

RECRUITING

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Kaohsiung City, 80756, Taiwan

RECRUITING

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Taichung, 40705, Taiwan

RECRUITING

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Taipei, 10002, Taiwan

RECRUITING

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Taoyuan District, 333, Taiwan

RECRUITING

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Yunlin, 640, Taiwan

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Zhubei, 302, Taiwan

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Cambridge, CB2 0QQ, United Kingdom

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Cardiff, CF14 4XW, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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London, EC1A 7BE, United Kingdom

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London, SE1 9RT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 6, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): February 18, 2028
• Study Completion (Estimated): February 18, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

DE (6); AU (3); GB (5); US (21); CA (4); CN (13); IT (6); ES (5); TW (6); IN (6); JP (7); FR (7)