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Study of baxdrostat compared to placebo to treat adults with primary aldosteronism

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Primary Aldosteronism, a condition where the body produces too much of a hormone called aldosterone. The study will test a medication called Baxdrostat (also known as CIN-107) to see how well it works and how safe it is for treating this condition. Primary Aldosteronism can cause high blood pressure and changes in blood potassium levels.

The study will compare Baxdrostat tablets with placebo in adults who have Primary Aldosteronism. During the study, participants will take either Baxdrostat or placebo orally each day. The medication dose may range from 2 to 4 milligrams per day. The main purpose is to determine if Baxdrostat can help lower blood pressure in people with this condition.

The treatment period will last for about one year (52 weeks). Throughout the study, participants will have their blood pressure monitored, and doctors will check various health measurements including hormone levels in blood and urine. The study will also track how the medication affects potassium levels in the blood.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility for the study will be confirmed based on the following criteria:

    - Age must be 18 years or older

    - Confirmed diagnosis of primary aldosteronism (a condition with excess hormone production)

    - Kidney function test result (eGFR) must be 45 mL/min/1.73m2 or higher

    - Blood potassium level must be between 3.0 and 5.0 mmol/L

    - Blood pressure reading must show systolic pressure of 135 mmHg or higher

  2. Step 2

    Medication adjustment period

    If you are currently taking certain blood pressure medications (mineralocorticoid receptor antagonists or potassium-sparing diuretics), you will need to stop taking them

    Your other blood pressure medications must remain unchanged for at least 4 weeks before the study begins

  3. Step 3

    Treatment period - First 8 weeks

    You will receive either baxdrostat tablets or placebo tablets (tablets with no active medication)

    The tablets should be taken by mouth according to the provided schedule

    Your blood pressure will be monitored regularly

    Blood tests will be performed to check your potassium levels and other parameters

  4. Step 4

    Extended treatment period

    The study continues through week 52

    Regular monitoring of your blood pressure will continue

    Additional tests will measure hormone levels in your blood and urine

    Your kidney function will be monitored through urine tests

Who can join the trial?

7 criteria

  • Must be at least 18 years old
  • Must have a confirmed diagnosis of Primary Aldosteronism (a condition where the body produces too much of a hormone called aldosterone) according to specific medical guidelines
  • Must be willing to stop taking certain medications called mineralocorticoid receptor antagonists (MRA) or potassium-sparing diuretics (medications that help remove excess water from the body while keeping potassium)
  • Must have a kidney function test (eGFR) result of 45 or higher at screening (this test measures how well your kidneys are working)
  • Must have a blood potassium level between 3.0 and 5.0 mmol/L at screening
  • Must be on a stable dose of blood pressure medications for at least 4 weeks before starting the study
  • Must have an average seated systolic blood pressure (the top number in a blood pressure reading) of 135 or higher when measured by an automatic blood pressure monitor

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • History of heart attacks or myocardial infarction (damage to heart muscle due to blocked blood flow)
  • Uncontrolled diabetes mellitus (high blood sugar levels)
  • Severe kidney disease or renal impairment
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials
  • History of substance abuse within the past 12 months
  • Severe liver disease or hepatic dysfunction
  • Known allergies to the study medication or its components
  • Major surgery within the last 3 months
  • Malignancy (cancer) within the past 5 years, except for successfully treated skin cancer
  • Inability to provide informed consent
  • Psychiatric conditions that could interfere with study participation
  • History of non-compliance with medical treatments
  • Life expectancy less than 12 months due to any medical condition
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Investigated drugs

Baxdrostat is a new medication being studied for treating primary aldosteronism, a condition where the body produces too much of a hormone called aldosterone. This medication works by helping to control blood pressure in people who have this condition. It is being tested to see how well it works compared to a placebo and how safe it is for patients to use.

What is already known about the treatment

Baxdrostat - An oral medication specifically designed to treat Primary Aldosteronism, a condition characterized by excess aldosterone production in the body. This drug works by selectively inhibiting aldosterone synthase, the enzyme responsible for aldosterone production, thereby helping to regulate blood pressure and electrolyte balance. Baxdrostat belongs to the class of aldosterone synthase inhibitors and is currently being evaluated in clinical trials as a potential treatment option for patients with primary aldosteronism who experience elevated systolic blood pressure. The medication is administered in tablet form and represents a novel therapeutic approach in managing this specific form of secondary hypertension.

Investigated diseases

Primary Aldosteronism - A hormonal disorder where the adrenal glands produce too much of the hormone aldosterone. This excess aldosterone causes the body to retain sodium and lose potassium, leading to an imbalance in these important minerals. The condition affects the body's ability to regulate blood pressure and maintain proper fluid balance. Primary aldosteronism typically develops gradually and can cause high blood pressure that doesn't respond well to standard blood pressure medications. The disorder can affect both kidneys and the body's overall salt-water balance.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520740-16-00Protocol codeD6974C00001Estimated enrolment180 patientsSponsorAstraZeneca AB

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