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Study of Sotatercept for Patients with Severe Pulmonary Arterial Hypertension at High Risk of Mortality

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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 Pulmonary Arterial Hypertension (PAH), a condition where the blood pressure in the arteries of the lungs is higher than normal. The study is evaluating a treatment called sotatercept, which is given as a solution for injection. Sotatercept is also known by the code name MK-7962. The purpose of the study is to assess the effects of sotatercept when added to the maximum tolerated background therapy for PAH, compared to a placebo, in participants who are at high risk of mortality and classified as World Health Organization (WHO) Functional Class III or IV.

Participants in the study will receive either sotatercept or a placebo, in addition to their existing PAH therapy. The study will monitor the time to the first event of all-cause death, lung transplantation, or PAH worsening-related hospitalization lasting 24 hours or more. The study aims to understand how sotatercept affects these outcomes in people with severe PAH. The treatment period is expected to last up to 40 weeks, during which participants will have regular check-ups and assessments to track their health and response to the treatment.

This study is designed to provide valuable information on the potential benefits of sotatercept for individuals with severe PAH, helping to determine if it can improve survival and reduce the need for lung transplantation or hospitalization due to worsening PAH. Participants will be closely monitored throughout the study to ensure their safety and well-being.

The research process

The trial runs in 5 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, eligibility is confirmed based on specific criteria such as age, diagnosis of pulmonary arterial hypertension (PAH), and stability on current PAH therapies.

    Participants must be between 18 and 75 years old and have a confirmed diagnosis of PAH through right heart catheterization.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to document the participant's health status and confirm the diagnosis of PAH.

    This includes a right heart catheterization to measure pulmonary vascular resistance and other heart pressures.

  3. Step 3

    Treatment phase

    Participants receive either the study drug, sotatercept, or a placebo. Both are administered as a solution for injection under the skin (subcutaneous).

    The treatment is given in addition to the participant's maximum tolerated background PAH therapy.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored regularly to assess the effects of the treatment. This includes checking for any worsening of PAH, hospitalizations, or other health events.

    Regular follow-up visits are scheduled to evaluate overall health, including changes in exercise capacity and heart function.

  5. Step 5

    End of study

    The study concludes with a final assessment to determine the overall impact of the treatment on the participant's health.

    Participants are evaluated for any changes in their condition and the need for further treatment is assessed.

Who can join the trial?

10 criteria

  • Participants must be between the ages of 18 and 75.
  • Participants need to have a confirmed diagnosis of **Pulmonary Arterial Hypertension (PAH)** through a test called **right heart catheterization**. This test checks the pressure in the heart and lungs.
  • Participants should have **symptomatic PAH**, which means they have noticeable symptoms, and it should be classified as **WHO FC III or IV**. These are categories that describe the severity of the condition.
  • Participants must have a **REVEAL Lite 2.0 risk score** of 9 or higher. This score helps to assess the risk level of the disease.
  • During screening, or within two weeks before, another **right heart catheterization** should show a **PVR** (Pulmonary Vascular Resistance) of 5 or more **Wood units** and a **PCWP** (Pulmonary Capillary Wedge Pressure) or **LVEDP** (Left Ventricular End-Diastolic Pressure) of 15 mmHg or less. These measurements help to understand the pressure in the lungs and heart.
  • Participants should be clinically stable and on stable doses of the maximum tolerated PAH therapies for at least 30 days before screening. This means their treatment should not have changed recently.
  • Females who can have children must have two negative pregnancy tests before starting the study and agree to ongoing pregnancy testing. They must use highly effective birth control methods before and during the study and for 16 weeks after the last dose of the study drug.
  • Male participants must agree to use a condom during sexual contact with a pregnant female or a female who can have children while in the study and for 16 weeks after the last dose. They should also not donate blood or sperm during this time.
  • Participants must be able to attend all study visits and follow all study requirements.
  • Participants must be able to understand and sign a written consent form to participate in the 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 at high risk of mortality with WHO FC III or FC IV PAH are excluded. WHO FC III and FC IV are classifications that describe the severity of PAH symptoms.
  • Patients who cannot tolerate the maximum background PAH therapy are excluded. This means if the patient cannot handle the highest dose of their current PAH treatment, they cannot join.
  • Patients who have had a lung transplant or are on the waiting list for one cannot participate.
  • Patients who have been hospitalized for PAH worsening for less than 24 hours are excluded.
  • Patients who are not within the specified age range for the study cannot participate. The study includes adults and older adults.
  • Patients who are not willing or able to follow the study procedures and requirements are excluded.
  • Patients who are part of a vulnerable population, such as those unable to give informed consent, are excluded.
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Investigated drugs

Sotatercept is a medication being studied for its potential to help people with pulmonary arterial hypertension (PAH), a condition that affects the blood vessels in the lungs and can lead to heart failure. In this trial, sotatercept is added to the maximum tolerated background therapy that participants are already receiving for PAH. The goal is to see if sotatercept can improve outcomes such as reducing the risk of death, the need for lung transplantation, or hospitalization due to worsening PAH symptoms.

What is already known about the treatment

Sotatercept – Sotatercept is administered via injection and is currently being studied in clinical trials for its potential use in treating Pulmonary Arterial Hypertension (PAH). It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for sotatercept is to improve outcomes in patients with PAH, particularly those at high risk of mortality. At the molecular level, sotatercept works by modulating the signaling pathways involved in blood vessel function, aiming to reduce the pressure in the pulmonary arteries. It is classified pharmacologically as a receptor fusion protein.

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 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 the lungs, which can lead to heart strain and eventual heart failure. Symptoms often include shortness of breath, fatigue, chest pain, and swelling in the legs and ankles. Over time, the condition can progress, causing more severe symptoms and complications. It is considered a rare disease and can significantly impact a person's quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509140-10-00Protocol codeA011-14Estimated enrolment184 patientsSponsorAcceleron Pharma Inc.

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