Study on the Safety and Tolerability of Sotatercept for Patients with Pulmonary Arterial Hypertension

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What is this study about?

This clinical trial is focused on studying Pulmonary Arterial Hypertension (PAH), a condition where the blood pressure in the arteries of the lungs is higher than normal. The study will use a treatment called sotatercept, which is administered as a solution for injection. Sotatercept is being tested to see how safe and tolerable it is for people with PAH when given in doses based on their weight.

The purpose of the study is to evaluate the long-term safety and tolerability of sotatercept. Participants will receive sotatercept through injections under the skin. The study will monitor participants over a period to observe any side effects or adverse events that may occur. The study aims to ensure that sotatercept can be safely used by people with PAH as part of their standard care.

Participants in this study will have completed a previous study involving sotatercept and will not have started treatment with commercially available sotatercept. The study will track the number of participants who experience adverse events and those who discontinue the study due to these events. This information will help determine the safety of sotatercept for long-term use in managing PAH.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. This study is designed to evaluate the long-term safety and tolerability of sotatercept in individuals with pulmonary arterial hypertension (PAH).

2 eligibility confirmation

Your eligibility will be confirmed based on specific criteria. You must have completed the treatment period of the previous study (MK-7962-024) and not have started treatment with commercially available sotatercept.

3 treatment administration

You will receive sotatercept as a solution for injection. The medication will be administered subcutaneously, which means it will be injected under the skin. The dosage will be determined using a weight-banded approach, ensuring it is appropriate for your body weight.

4 monitoring and follow-up

Throughout the study, you will be monitored for any adverse events, which are any unwanted effects or reactions. Regular follow-up visits will be scheduled to assess your health and the tolerability of the treatment.

5 study duration

The study is expected to continue until September 30, 2027. Your participation will involve regular visits and assessments during this period to ensure your safety and the effectiveness of the treatment.

Who Can Join the Study?

The patient must have completed the treatment period of the study called MK-7962-024 (LIGHTRAY), including Visit 11, without stopping the study treatment.
The patient must be able to safely join the new study called MK-7962-031 (LIGHTRAY EXTENSION).
The patient must not have started treatment with the commercially available drug called sotatercept.
The patient can be of any gender, as both males and females are eligible.
The patient must be within the age range specified by the study, which includes both adults and older adults.

Who Cannot Join the Study?

Patients with any other serious medical condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent heart attack or stroke.
Patients with uncontrolled high blood pressure.
Patients who have had a major surgery within the last 3 months.
Patients with a history of severe allergic reactions to similar medications.
Patients who are currently participating in another clinical trial.
Patients with severe liver or kidney disease.
Patients with a history of drug or alcohol abuse within the last year.
Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
CHU Gabriel-Montpied	Clermont Ferrand	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Gottsegen National Cardiovascular Center	Budapest	Hungary
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Semmelweis University	Budapest	Hungary
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Servei De Salut De Les Illes Balears	Palma	Spain
University Of Szeged	Szeged	Hungary
Hicsqvwd Ubakkfibonhgo Martkvz Dz Vcvqfgzfes	Santander	Spain
Ayqahsdzco Pnobcqre Hazyopjp Dx Mvvtvhujt	Marseille	France
Adwfmgc Usfve Skejydxtd Lguctj Dx Biqzdqd	Bologna	Italy
Uiclikfhun Ddjch Ssaju Dp Rwze La Sdhfxkug	Rome	Italy
Fzjzdrdsm Prnd Lz Icnvmptptcrpl Bnakzshze Dbg Hcpdyjrr Ubqbkqttqfqpc Lk Pzm	Madrid	Spain
Hkqvpqzu Vjpd dtlmzcpd	Barcelona	Spain
Kilzkwnjz Skyslba Skyzwshuymbrsmd ib Jbyl Psmhr In	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	15.05.2025
France	Not recruiting	15.05.2025
Hungary	Not recruiting	15.05.2025
Italy	Not recruiting	15.05.2025
Poland	Not recruiting	15.05.2025
Spain	Not recruiting	15.05.2025
The Netherlands	Not recruiting	15.05.2025

Trial locations

Investigated drugs:

Sotatercept

Sotatercept (MK-7962) is a medication being studied for its potential to help people with Pulmonary Arterial Hypertension (PAH). PAH is a condition where the blood pressure in the arteries of the lungs is higher than normal, which can make it hard for the heart to pump blood through the lungs. Sotatercept works by targeting specific pathways in the body that are involved in the development of PAH. The goal of this study is to see if sotatercept is safe and can be tolerated by patients over a long period. It is given to patients based on their weight, which means the amount of medication is adjusted according to how much a person weighs. This study is an open-label extension, meaning that both the researchers and the participants know that they are receiving sotatercept, and it is added to the standard treatments that patients with PAH are already receiving.

Investigated diseases:

Pulmonary arterial hypertension

Pulmonary Arterial Hypertension (PAH) – Pulmonary Arterial Hypertension is a condition characterized by high blood pressure in the arteries that supply the lungs. This disease causes the small arteries in the lungs to become narrowed or blocked, leading to increased resistance to blood flow. As a result, the heart must work harder to pump blood through these arteries. Over time, this increased workload can lead to the enlargement and weakening of the heart. Symptoms often include shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. The progression of the disease can lead to further complications affecting the heart and lungs.

Trial ID:

2024-518687-12-00

Protocol code:

MK-7962-031

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Tolerability of Sotatercept for Patients with Pulmonary Arterial Hypertension

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