Long-term study of sotatercept added to standard treatment in patients with pulmonary arterial hypertension

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What is this study about?

This study involves people with Pulmonary Arterial Hypertension, which is a condition where the blood pressure in the arteries of the lungs becomes abnormally high, making it harder for the heart to pump blood through the lungs. The treatment being studied is sotatercept, which is also known by its code name MK-7962. This medication is given as an injection under the skin and is used in addition to other treatments that people with this condition are already taking. The purpose of this study is to look at the long-term safety of sotatercept and how well people tolerate it over time.

This study is designed for people who have already completed a previous study called MK-7962-004. People who join this study will continue to receive sotatercept for up to 36 months while being closely monitored. During the study, doctors will check for any unwanted effects or side effects that might occur, and they will measure various health indicators through blood tests and other examinations. These tests will look at things like red blood cells, white blood cells, liver function, kidney function, and other important markers in the blood.

Throughout the study, doctors will also measure how well the treatment is working by checking several things, including how far people can walk in six minutes, levels of a substance in the blood that indicates heart stress, blood pressure in the lung arteries, and whether people’s overall functional status improves or stays stable. The study will also check if people develop any immune response to the medication by testing for antibodies. Regular monitoring will include checking body weight, blood pressure, and heart electrical activity to ensure safety during the treatment period.

1 Enrollment and baseline assessment

Upon entering this study, your initial health status will be recorded. This includes measurements of your body weight, blood pressure, and an electrocardiogram (a test that records the electrical activity of your heart).

Blood samples will be collected to check various parameters including red blood cell count, white blood cell count, platelet count, hemoglobin (the protein in blood that carries oxygen), and hematocrit (the proportion of blood made up of red blood cells).

Additional blood tests will measure levels of substances such as blood urea, creatinine, bilirubin, liver enzymes (aspartate aminotransferase, alanine transaminase, alkaline phosphatase), minerals (sodium, potassium, chloride, calcium, phosphorous, magnesium), glucose, carbon dioxide, and albumin.

A 6-minute walk test will be performed to measure how far you can walk in six minutes.

Blood will be tested for NT-proBNP levels, a substance that indicates how well your heart is functioning.

Your functional status will be assessed using the World Health Organization Classification, which categorizes how much your condition limits your daily activities.

A measurement called pulmonary vascular resistance will be taken to assess the blood flow through the vessels in your lungs.

Your risk level will be evaluated using the Simplified French Risk Score Calculator.

2 Treatment with sotatercept

You will receive sotatercept, which is administered as an injection under the skin (subcutaneous injection).

The medication is provided as a solution for injection.

Sotatercept will be given in addition to your existing treatment for pulmonary arterial hypertension (high blood pressure in the arteries of the lungs).

The specific dosage, frequency, and duration of sotatercept administration will be determined according to the study protocol and your individual response to treatment.

3 Regular monitoring visits

Throughout the study, you will attend scheduled visits to monitor your health and response to treatment.

At these visits, the same assessments performed at baseline will be repeated, including measurements of body weight, blood pressure, and electrocardiogram.

Blood samples will be collected regularly to monitor hematology parameters (blood cell counts and related measurements) and chemistry parameters (various substances in your blood).

The 6-minute walk test will be repeated to track changes in your exercise capacity.

NT-proBNP levels will be measured to monitor heart function.

Your functional status according to the World Health Organization Classification will be reassessed.

Pulmonary vascular resistance measurements will be repeated.

Your risk level using the Simplified French Risk Score Calculator will be reevaluated.

Any side effects or health changes you experience will be recorded and assessed.

4 Antibody testing

Blood samples will be collected at specified times to check for the presence of anti-drug antibodies.

Anti-drug antibodies are proteins your immune system may produce in response to the study medication.

5 Long-term follow-up

This is a long-term study designed to evaluate the safety and effects of sotatercept over an extended period.

You will continue to receive sotatercept injections and attend monitoring visits according to the study schedule.

The study is expected to continue until December 2028.

Throughout your participation, all safety measurements and assessments will be repeated at regular intervals to track your health status and any changes over time.

Who Can Join the Study?

    To join this study, you must meet these requirements:

  • You must have finished all the required parts of the previous study called MK-7962-004, which means you completed that earlier research study
  • You must be willing to come to all the planned study visits at the times they are scheduled
  • You must understand all the rules and requirements of the study
  • You must be able to follow and complete everything the study asks you to do
  • This study accepts both male and female participants
  • This study is for adults and elderly people

Who Cannot Join the Study?

  • The study does not list specific reasons why patients cannot participate in the trial
  • If you are interested in this study, a doctor will need to review your complete medical history to determine if you are suitable to take part
  • General factors that often prevent participation in clinical trials may include having other serious medical conditions, taking certain medications that could interfere with the study drug, or being pregnant or planning to become pregnant
  • The study doctor will discuss all requirements with you during the screening process, which is the period when the medical team checks if you meet all conditions to join the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Medizinische Hochschule Hannover Hanover Germany
CHU Grenoble Alpes La Tronche France
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium
DRK Kliniken Berlin Berlin Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Krankenhaus Neuwittelsbach Munich Germany
Saarland University Hospital Homburg Germany
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
Onassis Cardiac Surgery Center Kallithea Greece
Uljlnjssze Gojrojt Htxdrawd Od Tlywyqadtgwz Ayytj Thessaloniki Greece
Hugppfia Vcet dwbcwiwm Barcelona Spain
Uxevvnnqfy Hlibgfdz Chlhhlp Cologne Germany
Aqaskmdfa Uyy Amsterdam The Netherlands
Hrxpmwsw Chxeuo Df Bjmcfxqjz Barcelona Spain
Ehxtrut Uomdefburqdp Mnuwtjp Cnkpstq Rdnycopfw (cxbbbyo Mus Rotterdam The Netherlands
Sjcainigz Rjewcxh Uhefzistkv Mtzvkri Cegdkr Nijmegen The Netherlands
Afujkvy Ortqfvnpita Uxatzxihuwzjy Faqpxxkr Ic Dl Nnkkuk Naples Italy
Jrnmxitkzxnxziiowccchqhjyn Gxmhecw Giessen Germany
Rxtkwh Mkjkektmgqv Aarhus Denmark
Vlexqqovy Fewkplzj Ndduffuug V Pnhgb Prague Czechia
Uztdxkwuirep Lihukou Leipzig Germany
Tzndptuhxrpm Hgklsfsymq grufm Heidelberg Germany
Rskimgpwdpltlz Copenhagen Denmark
Kuk Syqfp Split Croatia
Uetolgpjcv Dtwgj Suhni Dh Rqjo Lb Sxdfvcqv Rome Italy
Itdhdptcx Fhz Cxmvuuns Aly Ezpdhoiazbva Mddtsuaw Prague Czechia
Ctjykl Hlgmyqckhbg Lkqa Snk Pierre Benite France
Hfqrxskx Uxsrizlujdhye Puhgwn Dt Hlvzeq Du Mwvcekksvzs Majadahonda Spain
Hhcikumm Uadqvtzwjmkds 1p Dv Ovvbgjg Madrid Spain
Hrjqxaik Uuzuirbltjtee Mmljnej De Vobevfhwwn Santander Spain
Cwalqy Hhwcbtxdapx Rotxmqba Dodlbehjimjqxk Angers France
Sagoao Dw Sthhy Dc Lkn Iosdo Bwtphcp Palma Spain
Qqsqg Sddqop Cxzyiemqk Hmaxlxgc &xjmvgw Sjlobalwhql Uzsoaisvjf Hjknlrlc &yxzzxl Vksmopn Gukozjxonfiazpunfb Gothenburg Sweden
Funqpqngg Poik Lz Itfxbshikbyas Bgnedozws Dux Huodtmus Ubgtbpwfjjiqx Lo Plj Madrid Spain
Fxxxfctqdz Impvx Szc Gdoicsb Dao Tidgzsk Monza Italy
Hsmzdfyx Usvudysjuntpoq Scdzzabhmo &dxmcuj Hkagijh dq Hoptlhnkoel STRASBOURG, Alsace France
Uxxkxvwzph Gdxuawt Hqqngixa Agnqsfg Gxrmciy Hbwplihr Ok Wfdn Axkjmn H Arrf Vfkglwh Chaidari Greece
Iuzvtptu dl Cwxvkrnqwpjr Hthcnfdolhp Uzhflexcpewca dx Snwpk Esujejf (yrqxayl Saint Priest En Jarez France
Ueaprmmnqfefyvrvvters Rscmoepiqb Aby Regensburg Germany
Cigxyb Hmducflnqwm Utpeyymyowpvh Dh Pklrbsib Poitiers France
Moocakwhkqpzqyolfqyfwkbsed Htdmqgvkzymqjsgz Halle (Saale) Germany
Msbgvlwdrus Sbmtal Milan Italy
Kuzuxphas Szwidao Svmhriqftbsufvd ib Jxbe Poovk Id Cracow Poland
Beymvxo Husfzlsz Le Kremlin-Bicetre France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
14.11.2025
Croatia Croatia
Not recruiting
14.11.2025
Czechia Czechia
Not recruiting
14.11.2025
Denmark Denmark
Not recruiting
14.11.2025
France France
Recruiting
14.11.2025
Germany Germany
Recruiting
14.11.2025
Greece Greece
Not recruiting
14.11.2025
Italy Italy
Not recruiting
14.11.2025
Poland Poland
Not recruiting
14.11.2025
Portugal Portugal
Not recruiting
14.11.2025
Spain Spain
Not recruiting
14.11.2025
Sweden Sweden
Not recruiting
14.11.2025
The Netherlands The Netherlands
Not recruiting
14.11.2025

Trial locations

Investigated Drugs:

Sotatercept is an investigational medication being studied for the treatment of pulmonary arterial hypertension, which is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. This medication is given in addition to other standard treatments that patients are already taking for their condition. In this study, researchers want to see how safe the medication is and how well patients tolerate it when used over a long period of time.

Investigated Diseases:

Pulmonary Arterial Hypertension – Pulmonary Arterial Hypertension is a condition where the blood pressure in the arteries of the lungs becomes abnormally high. The small blood vessels in the lungs become narrowed, blocked, or damaged, making it harder for blood to flow through them. As a result, the right side of the heart must work harder to pump blood through the lungs. Over time, the heart muscle weakens and becomes less able to pump blood effectively. People with this condition often experience shortness of breath, fatigue, chest pain, and dizziness. The disease progressively worsens as the blood vessels continue to narrow and the heart becomes increasingly strained.

Trial ID:
2025-521970-33-00
Protocol code:
MK-7962-038
NCT ID:
NCT04796337
Trial Phase:
Therapeutic confirmatory (Phase III)

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