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Long-term Study of Sotatercept for Adults with Pulmonary Arterial Hypertension (PAH)

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Pulmonary Arterial Hypertension (PAH), a condition where the blood pressure in the arteries of the lungs is higher than normal. The treatment being studied is called sotatercept, which is also known by its code name MK-7962. Sotatercept is a solution for injection and is being tested to see how safe and tolerable it is when used alongside existing PAH therapies.

The purpose of this study is to evaluate the long-term safety and tolerability of sotatercept in adults with PAH. Participants in the study will receive sotatercept through an injection under the skin. The study will follow participants over a period to monitor their health and any side effects they may experience. This is an open-label study, meaning that both the researchers and participants know what treatment is being administered.

Throughout the study, participants will have regular check-ups to assess their health, including tests like blood work and heart monitoring. The study aims to gather information on how well sotatercept works in the long term and its impact on the participants' overall health and quality of life. This information will help determine the potential benefits and risks of using sotatercept as a treatment for PAH.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants must have completed their previous PAH sotatercept clinical study and met all requirements without early discontinuation.

    Participants must agree to follow the study visit schedule and comply with all protocol requirements.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure eligibility, including a review of medical history and current health status.

    Females of childbearing potential will undergo a pregnancy test before starting the study drug.

  3. Step 3

    Medication administration

    The study involves the administration of sotatercept, a solution for injection given subcutaneously.

    Participants will receive the medication as part of their ongoing treatment for pulmonary arterial hypertension (PAH).

  4. Step 4

    Ongoing monitoring

    Participants will be monitored for adverse events, anti-drug antibodies, and undergo clinical laboratory assessments including blood tests and urinalysis.

    Vital signs and a 12-lead electrocardiogram (ECG) will be regularly checked.

  5. Step 5

    Secondary assessments

    Secondary assessments will include measuring the 6-minute walk distance, evaluating the N-terminal pro-hormone B-type natriuretic peptide levels, and assessing the World Health Organization (WHO) functional class.

    Pulmonary vascular resistance and overall survival will also be evaluated, along with the Simplified French Risk score.

  6. Step 6

    Completion of study

    The study is estimated to conclude by June 28, 2028.

    Participants must refrain from participating in other investigational drug or device trials during this study.

Who can join the trial?

9 criteria

  • Participants must have completed their current Pulmonary Arterial Hypertension (PAH) sotatercept clinical study and must not have left the study early.
  • Participants must be willing to follow the study visit schedule and understand and comply with all study requirements.
  • Participants must be able to understand and provide written consent to participate in the study.
  • Females of childbearing potential must:
    • Have a negative pregnancy test before starting the study medication and agree to ongoing pregnancy testing during the study and for 8 weeks after the last dose.
    • If sexually active, use highly effective birth control along with a barrier method for at least 28 days before starting the study medication, during the study, and for 16 weeks after stopping the medication.
    • Refrain from breastfeeding, donating blood, eggs, or ovum during the study and for 16 weeks after the last dose.
    • Male participants must:
      • Agree to use a condom during sexual contact with a pregnant female or a female who can become pregnant while in the study, during breaks in medication, and for 16 weeks after stopping the medication, even if they have had a vasectomy.
      • Refrain from donating blood or sperm during the study and for 16 weeks after the last dose.
      • Participants must agree not to join any other trials of experimental drugs or devices while enrolled in this study.

Who cannot join the trial?

8 criteria

  • Patients who have a different condition than Pulmonary Arterial Hypertension (PAH) cannot participate.
  • Patients who are not adults are excluded from the study.
  • Patients who are not already receiving treatment for PAH cannot join the study.
  • Patients who are unable to follow the study procedures or attend follow-up visits are not eligible.
  • Patients with any other medical condition that might interfere with the study results are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with a history of allergic reactions to the study medication are excluded.
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Investigated drugs

Sotatercept is a medication being studied for its potential to help treat pulmonary arterial hypertension (PAH). It is being tested to see how safe and tolerable it is for long-term use when added to other PAH treatments. This medication works by targeting specific pathways in the body that are involved in the development of PAH, with the aim of improving symptoms and outcomes for patients with this condition.

What is already known about the treatment

Sotatercept – Sotatercept is administered as an injection under the skin. It is currently being studied in clinical trials for its long-term safety and effectiveness in treating Pulmonary Arterial Hypertension (PAH). The main therapeutic indication for sotatercept is to improve the condition of patients with PAH when used alongside existing therapies. At the molecular level, sotatercept works by binding to certain proteins that regulate cell growth, which can help reduce the abnormal blood vessel changes seen in PAH. It is classified as a receptor fusion protein in pharmacology.

Investigated diseases

Pulmonary Arterial Hypertension (PAH) – Pulmonary Arterial Hypertension is a condition characterized by high blood pressure in the arteries that supply the lungs. This increased pressure makes it difficult for the heart to pump blood through the lungs, leading to symptoms such as shortness of breath, fatigue, and chest pain. Over time, the heart may become enlarged and weakened due to the increased workload. The disease progresses as the blood vessels in the lungs become more narrowed or blocked, further increasing the pressure. This can lead to complications such as heart failure if not managed. PAH is considered a rare disease and can significantly impact a person's quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509138-21-00Protocol codeA011-12Estimated enrolment838 patientsSponsorAcceleron Pharma Inc.

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