RecruitingPHASE4INTERVENTIONAL

Sotatercept in Pulmonary Arterial Hypertension

This research study is testing a new medicine called sotatercept for people living with pulmonary arterial hypertension (PAH). PAH is a serious condition where blood pressure in the arteries going to your lungs is too high. The main goal is to find out if sotatercept can help your lungs work better, specifically by improving how much oxygen they can take into your blood, especially when you are active. We also want to understand exactly how the medicine works to achieve this. By improving lung function, we hope to find a way to help people with PAH feel better and have an improved quality of life. This study is for adults over 18 with specific types of PAH who are already on other treatments.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

University of Alberta

Enrolment target

Start

06 Oct 2025

Estimated completion

01 Jan 2030

Pulmonary Artery Hypertension

What is this study about?

Pulmonary Arterial Hypertension (PAH) is a complex condition where the blood vessels in your lungs become narrow. This makes it harder for your heart to pump blood through them, leading to high blood pressure in your lungs. This can make you feel tired, breathless, and limit your daily activities. Currently, there are treatments for PAH, but researchers are always looking for new and better ways to help people.

This study is focusing on a new medicine called sotatercept. We want to see if this medicine can help your lungs take up oxygen more effectively. Think of your lungs like a sponge – the more efficiently it can soak up water (or oxygen, in this case), the better it works. We're particularly interested in how well your lungs perform during exercise, as this is often when people with PAH notice their symptoms most.

By carefully studying how sotatercept affects lung function, especially during physical activity, we hope to learn if it can make a real difference in the lives of people with PAH. The information gathered from this study could lead to new treatment options and help improve how people manage their condition and enjoy their lives.

Key takeaways

Tests a new drug, sotatercept, for PAH.
Aims to improve oxygen absorption in lungs.
Involves 18 clinic visits over 29 weeks.
Includes physical exams, lung, and heart tests.
Requires stable existing PAH medication.
You can leave the study at any time.

Who may be eligible?

To join this study, you must be 18 years or older. You should have been diagnosed with a specific type of PAH (Group 1 PAH), which would have been confirmed by a special heart test called a right heart catheterization. You also need to be experiencing some symptoms of PAH, generally classified as WHO Functional Class II or III, meaning you have some limitations in your daily activities due to your condition.

You should already be taking at least two different medicines for your PAH, and these medicines should have been at a stable dose for at least two months before you join the study. If you're on only one PAH medicine, you might still be eligible if other types of PAH medicines aren't suitable for you.

If you are a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective birth control throughout the study and for about four months after your last dose. You also can't be breastfeeding or donate eggs during this time. If you are a man, you must agree to use a condom during sex with a woman who could get pregnant for the duration of the study and for about four months after your last dose. You should also not donate blood or sperm during the study.

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?
Do you have a confirmed diagnosis of Group 1 PAH?
Are you currently taking at least two stable PAH medications (or one if others are not suitable)?
Are you experiencing some symptoms of PAH (WHO Functional Class II or III)?
If you are a woman who could get pregnant, are you willing to use effective birth control during and after the study?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be in it for about 29 weeks, which is roughly seven months. During this time, you will receive doses of sotatercept every 21 days (give or take three days). You'll need to visit the clinic a total of 18 times for various checks and tests.

These visits will include physical exams, where a doctor will check your overall health. You'll also have tests to see how well your lungs are working and how you perform during exercise. An ultrasound of your heart will be done, and you will have blood samples taken regularly to monitor your health and how the treatment is affecting you.

Before you start, there will be a screening period over two weeks with three visits to make sure the study is right for you. Some initial visits may involve travel if you're coming from the Calgary area. All study procedures will happen before you receive your medicine dose on visit days.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new medication that could improve your lung function and overall well-being, though there's no guarantee the treatment will work for you. There could be side effects from sotatercept, and some of the tests, like blood draws, carry small risks. All procedures will be explained in detail, and your safety is a top priority. Remember, participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Clinical Physiology Laboratory
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is pulmonary arterial hypertension (PAH)?

PAH is a condition where the blood pressure in the arteries leading to your lungs is too high, making it harder for your heart to pump blood.

What is sotatercept?

Sotatercept is the new medicine being tested in this study to see if it can improve lung function in people with PAH.

How long will I be in the study?

You will be in the study for approximately 29 weeks, which is about seven months.

Will I have to travel for the study?

Some initial visits may require travel, especially for participants from the Calgary area, who might need to visit Edmonton.

Can I stop participating if I want to?

Yes, you can withdraw from the study at any time without giving a reason, and it won't affect your medical care.

How to find out more

Desi Fuhr, MSc

fuhr@ualberta.ca 7804921121 Official trial record

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