Active not recruitingPHASE2INTERVENTIONAL

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)

This research study is investigating a new medication called sotatercept for people living with pulmonary arterial hypertension (PAH). PAH is a condition where blood pressure in the arteries leading to the lungs is too high. This particular study is an extension of an earlier study (MK-7962-024, also known as LIGHTRAY) that looked at how safe and effective sotatercept was. Now, researchers want to continue learning more about sotatercept, specifically when it's given in doses that are adjusted based on a person's weight group. The main goal is to understand if these weight-based doses are safe and well-tolerated by participants over a longer period.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

130

Start

12 May 2025

Estimated completion

16 Jun 2028

Pulmonary Arterial Hypertension

What is this study about?

Pulmonary arterial hypertension, often called PAH, is a serious condition where the blood vessels in your lungs become narrow, making it harder for your heart to pump blood through them. This can lead to symptoms like breathlessness and tiredness. Researchers are urgently looking for new and better ways to treat PAH to help people feel better and live longer.

This study is focusing on a new medicine called sotatercept. We know from earlier research that sotatercept shows promise in treating PAH. A previous study, called LIGHTRAY, already looked into how safe sotatercept was and how well it worked for people with PAH. That study also explored different ways of giving the medicine, either based on a person's exact weight or using doses that fit within certain weight ranges.

This new study, called LIGHTRAY EXTENSION, is for people who took part in the original LIGHTRAY study. It's a chance for them to continue receiving sotatercept. The main aim here is to understand if giving sotatercept in doses based on weight groups (rather than exact weight) is safe and if people can continue taking it over a longer period without significant problems. This helps doctors understand the long-term effects and how best to give the medicine if it becomes widely available.

Key takeaways

This study is for people previously in the LIGHTRAY study for PAH.
It aims to learn more about the long-term safety of sotatercept.
Sotatercept doses will be based on weight groups (weight-banded).
It's a research study, not standard treatment.
All participants will continue to receive sotatercept.

Who may be eligible?

To join this particular study, you must have already taken part in the previous LIGHTRAY study (MK-7962-024) and completed the treatment period there. You should not have stopped taking the study medicine in that previous study and must be considered safe to continue in this extension study.

It's also important that you haven't started taking sotatercept that is bought from a chemist or prescribed normally, as this study is still part of the research process. You also shouldn't be taking any other similar medicines that work in the same way as sotatercept.

Anyone aged 18 years and older, male or female, who meets these criteria may be able to join. Your study doctor will check all these points to see if this study is suitable for you.

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.

Did you complete the previous LIGHTRAY study (MK-7962-024)?
Did you stay on the study treatment throughout that previous study?
Are you currently not taking commercially available sotatercept?
Are you not taking any other similar activin signalling inhibitor medicines?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the study medicine, sotatercept, which will be given in doses based on your weight group. You will also continue with any other PAH treatments your doctor has prescribed, as sotatercept is meant to be an add-on treatment. You will have regular visits to the clinic so the study team can monitor your health, check for any side effects, and make sure the treatment is working well. These visits will involve various checks, including physical exams, blood tests, and possibly other tests related to your heart and lung health. The study aims to follow participants for a longer time to understand the long-term safety of sotatercept when given using a weight-based dosing plan. The specific number and frequency of visits, and the total duration you'll be in the study, will be fully explained by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit of continuing access to a new treatment for PAH that could help manage your condition. However, like all medicines, sotatercept may have side effects, and some might not yet be fully known. The study team will closely monitor you for any potential risks or side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (73)

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

University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930)
Verified postcode
Aurora, United States
University of Kansas Medical Center ( Site 1928)
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Kansas City, United States
University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)
Verified postcode
Albuquerque, United States
Centro Medico Capital ( Site 0002)
Verified postcode
La Plata, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)
Verified postcode
Mar del Plata, Argentina
Instituto Medico Rio Cuarto ( Site 0010)
Verified postcode
Río Cuarto, Argentina
Instituto de Cardiologia Juana F. Cabral ( Site 0008)
Verified postcode
Corrientes, Argentina
Hospital Provincial Jose Maria Cullen ( Site 0005)
Verified postcode
Santa Fe, Argentina
Royal Prince Alfred Hospital ( Site 0103)
Verified postcode
Camperdown, Australia
Westmead Hospital ( Site 0100)
Verified postcode
Westmead, Australia
Wesley Research Institute ( Site 0101)
Verified postcode
Auchenflower, Australia
The Alfred Hospital ( Site 0102)
Verified postcode
Melbourne, Australia

Common questions

What is pulmonary arterial hypertension (PAH)?

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

What is sotatercept?

Sotatercept is a new medicine being studied as a treatment for PAH. It's not yet available as a standard treatment.

Why is this an 'extension' study?

It's for people who were already in a previous study looking at sotatercept for PAH. It allows them to keep taking the medicine and helps researchers gather more long-term information.

Who can join this study?

Only people who finished the previous LIGHTRAY study safely and without stopping the study medicine are eligible for this extension study.

Are there different doses of sotatercept?

Yes, in this study, sotatercept will be given in doses that are adjusted based on a person's weight group.