Not yet recruitingNAINTERVENTIONAL

Baxdrostat and Molecular Imaging of Adrenal Cytoreduction in Primary Aldosteronism

This study is investigating a new medication called baxdrostat for people with a condition called primary aldosteronism. In this condition, the adrenal glands (small glands above your kidneys) make too much of a hormone called aldosterone, which can cause high blood pressure. The main goal is to see if baxdrostat can reduce this overproduction of aldosterone. We'll use special body scans and blood tests to measure any changes. Participants will take baxdrostat for 24 weeks, and we'll monitor their blood pressure and hormone levels. We'll also check if the changes last after they stop taking the drug. Everyone in the study will receive baxdrostat.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Queen Mary University of London

Enrolment target

Start

15 Sep 2026

Estimated completion

31 May 2028

Primary Aldosteronism

What is this study about?

This study is for people who have a condition called primary aldosteronism. This is a common cause of high blood pressure where your adrenal glands, which are small glands located on top of your kidneys, produce too much of a hormone called aldosterone. This extra aldosterone can lead to health problems like high blood pressure.

We are looking into a new medication called baxdrostat. This drug is designed to help reduce the amount of aldosterone your adrenal glands make. The main aim of this research is to find out if taking baxdrostat can actually change how active your adrenal glands are in producing this hormone. We’ll use special imaging techniques, like a type of body scan, to look at your adrenal glands before and after treatment with baxdrostat. This will help us see if the drug makes a difference to the aldosterone-producing cells.

Everyone who takes part in this study will receive baxdrostat for 24 weeks (about six months). We will also carefully check your blood pressure and hormone levels regularly throughout the study. A key part of our research is to understand if any positive changes from the drug continue even after you stop taking it. This study does not include a placebo (dummy drug) group; all participants will be given baxdrostat.

Key takeaways

This study investigates a new drug, baxdrostat, for high blood pressure caused by too much aldosterone.
It aims to see if baxdrostat reduces aldosterone production in the adrenal glands using special scans.
All participants will receive baxdrostat for 24 weeks.
Regular check-ups, blood tests, and special scans are part of the study.
The study also checks if benefits last after stopping the drug.
It's for adults with primary aldosteronism, with specific health requirements.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and have been diagnosed with primary aldosteronism. Doctors will also check for small growths (called nodules) on your adrenal glands using scans, and that these nodules look like the kind that produce aldosterone. Your kidneys and liver need to be working well, and your blood potassium levels should be within a healthy range. If you are a woman who could become pregnant, you'll need a negative pregnancy test.

There are also some reasons why you wouldn't be able to join. For example, if you're taking certain blood pressure medications or other specific drugs. You also can't have certain other health conditions, such as severe heart failure, uncontrolled diabetes, or particular kidney problems. We need to make sure that the study is safe and suitable for everyone involved.

Ultimately, you need to be willing to take the study drug for six months and attend all the planned check-ups and scans.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with primary aldosteronism?
Do you have small growths (nodules) on your adrenal glands?
Are you willing to take the study drug for six months and have scans?
Is your kidney function healthy enough?
Are you currently free from specific severe heart or kidney conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will take a medication called baxdrostat once a day for 24 weeks (about six months). During this time, and for a period afterwards, you will have regular check-ups. These check-ups will involve blood tests to measure your hormone levels and blood pressure readings. You will also have special body scans (called PET-CT scans) of your adrenal glands, both at the start of the study and again after your 24 weeks of treatment. These scans will help us see if the drug has changed how your adrenal glands are working. Some of these scans will take place at St Bartholomew's Hospital or Cambridge University Hospitals. The total duration of your involvement, including follow-up after stopping the medication, will be several months.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping to reduce your blood pressure and the effects of high aldosterone levels, using a new medication. However, as with any medication, there's a chance of side effects, which the study team will discuss with you. There are also risks associated with the scans, such as exposure to a small amount of radiation, similar to other X-ray procedures. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Cambridge NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom
Barts NHS Trust
Verified postcode
London, United Kingdom

Common questions

What is primary aldosteronism?

It's a condition where your adrenal glands make too much of a hormone called aldosterone, often leading to high blood pressure.

What is baxdrostat?

Baxdrostat is a new medicine being tested to see if it can lower the amount of aldosterone your body makes.

Will I receive a dummy drug (placebo)?

No, everyone who joins this study will receive the active medication, baxdrostat.

How long will I take the medication?

You will take baxdrostat for 24 weeks, which is about six months.

What kind of scans will I have?

You will have special PET-CT scans to look at your adrenal glands before and after treatment.

How to find out more

Aklima Khatun

aklima.khatun4@nhs.net 0203 465 8577 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.