RecruitingPHASE3INTERVENTIONAL

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

This study focuses on a medicine called sotatercept, which is being tested to treat Pulmonary Arterial Hypertension (PAH). PAH makes blood vessels in the lungs thick and narrow, causing high blood pressure in the lungs and making the heart work harder. This can lead to breathlessness and difficulty with daily activities. While current treatments help symptoms, they don't always stop PAH from getting worse. Sotatercept is a new type of treatment that targets specific proteins involved in causing PAH. This particular study is for people who have already used sotatercept in previous studies. Its main goal is to see how safe the medicine is over a longer period and if people can take it alongside their regular PAH medicines without too many problems.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

815

Start

12 May 2021

Estimated completion

07 Dec 2028

Pulmonary Arterial Hypertension

What is this study about?

Researchers are always looking for better ways to treat Pulmonary Arterial Hypertension (PAH). This is a condition where the blood vessels in your lungs become thick and narrow, making it difficult for blood to flow through them. This causes high blood pressure in your lungs and puts a lot of strain on your heart. People with PAH often find themselves short of breath and struggle with physical activity.

Currently, there are treatments that help with the symptoms of PAH, but they don't always stop the condition from worsening. This study is looking at a new medicine called sotatercept. Sotatercept is different because it's a 'targeted therapy.' This means it's designed to work specifically on certain proteins in your body that are thought to play a role in developing PAH.

This study is a 'long-term follow-up' study. This means it's for people who have already participated in other clinical trials for sotatercept. The main aim is to carefully monitor the safety of sotatercept over a longer period. Researchers also want to understand if people can comfortably take this medicine alongside their current, standard PAH treatments without experiencing too many side effects or difficulties.

Key takeaways

This study is for patients who have previously used sotatercept medicine for PAH.
It aims to find out if sotatercept is safe to use long-term with other PAH medicines.
Sotatercept is a targeted treatment for managing PAH.
You will need to attend regular check-ups if you join the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is specifically designed for people who have already taken part in previous studies testing sotatercept for PAH. If you didn't participate in one of those earlier studies, you won't be able to join this one.

To be considered, you must have completed your previous sotatercept study without dropping out early. You also need to be able to understand and agree to all the study requirements, including attending all scheduled visits. It's important to note that if you missed many doses of sotatercept between your last study and the start of this one (more than four doses), you might not be able to participate.

There are also some reasons why you wouldn't be able to join. For example, if you are currently pregnant or breastfeeding, or if you are already participating in another medical study for a different experimental medicine. If you or an immediate family member works on this study, you also wouldn't be eligible to take part.

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.

Have you already participated in a sotatercept study for PAH?
Did you complete your previous sotatercept study without dropping out early?
Are you 18 years old or older?
Are you currently pregnant or breastfeeding?
Are you able to attend all required study appointments?
Are you currently participating in another medical study for a different experimental drug?

Answer every question to see your result.

What does participation involve?

This is a long-term study that involves continuing to take the study medicine, sotatercept, alongside your usual PAH treatments. The study team will regularly check your health and how you're responding to the treatment. This will include attending scheduled clinic visits, likely involving physical examinations, blood tests, and other assessments to monitor your condition and ensure your safety. The exact number and frequency of visits, as well as the total duration you will be in the study, will be explained in detail by the study team. You will be expected to follow all instructions for taking the medicine and attending appointments.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as continuing to receive a medicine that might help manage your PAH symptoms or slow down the progression of your condition. However, there are also potential risks, including the possibility of side effects from sotatercept, which could range from mild to serious. The study team will monitor you closely for any unwanted effects. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (115)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Pulmonary Associates, PA ( Site 1008)
Verified postcode
Phoenix, United States· Active not recruiting
Arizona Pulmonary Specialists ( Site 1010)
Verified postcode
Scottsdale, United States· Recruiting
University of California San Diego Health ( Site 1002)
Verified postcode
La Jolla, United States· Active not recruiting
UC Irvine Health Medical Center ( Site 1086)
Verified postcode
Orange, United States· Recruiting
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)
Verified postcode
San Francisco, United States· Active not recruiting
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
Verified postcode
Santa Barbara, United States· Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
Verified postcode
Torrance, United States· Active not recruiting
University of Colorado Hospital ( Site 1013)
Verified postcode
Aurora, United States· Active not recruiting
Mayo Clinic Jacksonville ( Site 1045)
Verified postcode
Jacksonville, United States· Active not recruiting
AdventHealth Orlando ( Site 1058)
Verified postcode
Orlando, United States· Recruiting
University of Kansas Medical Center ( Site 1020)
Verified postcode
Kansas City, United States· Recruiting
Norton Pulmonary Specialists ( Site 1066)
Verified postcode
Louisville, United States· Recruiting

Common questions

What is PAH?

PAH stands for Pulmonary Arterial Hypertension. It's a condition where the blood vessels in your lungs become narrow, causing high blood pressure in your lungs and making your heart work harder.

What is sotatercept?

Sotatercept is a new medicine being tested to treat PAH. It's designed to target specific proteins that play a role in causing the condition.

Who can join this study?

This study is only for people who have previously taken part in other clinical trials for sotatercept for PAH.

Why is this study important?

This study helps researchers understand the long-term safety of sotatercept and how well it works alongside other PAH treatments over a longer period.

Can I stop being part of the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your regular medical care.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

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