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Study of Sotatercept for Newly Diagnosed Intermediate- and High-risk Pulmonary Arterial Hypertension Patients

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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 a condition known as Pulmonary Arterial Hypertension (PAH), which is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. The study is investigating a treatment called sotatercept, also known by its code name MK-7962, which is administered as a solution for injection. The purpose of the study is to evaluate the effects of sotatercept when added to existing PAH therapies in patients who have been newly diagnosed with intermediate- or high-risk PAH.

Participants in the study will receive either sotatercept or a placebo, in addition to their current PAH treatment. The study will monitor the participants over a period to assess the impact of the treatment on their condition. The trial aims to understand how sotatercept affects the progression of PAH and whether it can improve the health outcomes for those affected by this disease.

The study will involve regular check-ups and assessments to track the participants' health and response to the treatment. This includes monitoring exercise performance and other health indicators related to PAH. The trial is designed to provide valuable information on the potential benefits of sotatercept for individuals with PAH, contributing to the development of more effective treatment options for this challenging condition.

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, the participant will be randomly assigned to receive either the study medication, sotatercept, or a placebo. Both will be administered in addition to the participant's existing treatment for pulmonary arterial hypertension (PAH).

  2. Step 2

    Medication administration

    The study medication, sotatercept, is provided as a powder for injection. It is administered as a subcutaneous injection, which means it is injected under the skin.

    The frequency and dosage of the medication will be determined by the study protocol and communicated to the participant by the study team.

  3. Step 3

    Monitoring and assessments

    Participants will undergo regular monitoring and assessments to evaluate the effects of the treatment. This includes exercise testing, blood tests, and other evaluations to monitor heart function and overall health.

    The primary goal is to assess the time to clinical worsening (TTCW), which includes events such as hospitalization, worsening of symptoms, or changes in treatment needs.

  4. Step 4

    Follow-up visits

    Participants will attend scheduled follow-up visits throughout the study duration. These visits are essential for tracking progress and ensuring the safety and effectiveness of the treatment.

    During these visits, participants will be asked about any side effects or changes in their condition.

  5. Step 5

    Study completion

    The study is expected to continue until August 2029. Upon completion, participants will undergo a final assessment to evaluate the overall impact of the treatment.

    Participants will be informed about the study results and any potential next steps regarding their treatment.

Who can join the trial?

11 criteria

  • Must be **18 years or older**.
  • Must have a **right heart catheterization** test done within the last 12 months showing certain heart pressure measurements.
  • Must have a diagnosis of **PAH (Pulmonary Arterial Hypertension)**, which is a type of high blood pressure affecting the lungs and heart, in specific subtypes like idiopathic, heritable, drug-induced, or associated with certain conditions.
  • Must have **symptoms of PAH** that are classified as WHO FC II or III, which are categories describing the severity of symptoms.
  • Must have a certain **risk score** indicating intermediate or higher risk of PAH progression.
  • Must have been diagnosed with PAH within the last 12 months and be on stable doses of PAH medications for at least 90 days before the study.
  • Must be able to walk at least **150 meters** in a test done twice during screening, with both results being similar.
  • Females who can have children must have two negative pregnancy tests, agree to ongoing pregnancy testing, use effective birth control, and not breastfeed or donate eggs during the study and for a period after.
  • Male participants must agree to use condoms during sexual contact with women who can have children, and not donate blood or sperm during the study and for a period after.
  • Must be able to attend study visits and follow all study requirements.
  • Must be able to understand and sign a consent form agreeing to participate in the study.

Who cannot join the trial?

10 criteria

  • Participants who have a different type of lung disease other than **PAH**. **PAH** stands for **Pulmonary Arterial Hypertension**, which is high blood pressure in the lungs.
  • Participants who have had a heart attack or stroke in the last 6 months.
  • Participants who have severe liver disease. The liver is an organ that helps clean your blood and digest food.
  • Participants who have severe kidney disease. The kidneys are organs that help filter waste from your blood.
  • Participants who are pregnant or breastfeeding. This means women who are expecting a baby or are feeding a baby with breast milk.
  • Participants who are currently using certain medications that might interfere with the study treatment.
  • Participants who have a history of certain types of cancer.
  • Participants who have a history of drug or alcohol abuse in the past year. This means using drugs or alcohol in a way that is harmful.
  • Participants who have participated in another clinical trial within the last 30 days.
  • Participants who have any other medical condition that the study doctors think might make it unsafe for them to participate.
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Investigated drugs

Sotatercept is a medication being studied for its potential to help patients with pulmonary arterial hypertension (PAH). It is being tested to see if it can improve the condition of patients who have recently been diagnosed with PAH and are at an intermediate or high risk of the disease getting worse. This medication is used in combination with other standard treatments for PAH to see if it can provide additional benefits.

What is already known about the treatment

Sotatercept – Sotatercept is administered as an injection, typically under the skin. It is currently in Phase III clinical trials, which means it is being tested for safety and effectiveness in a larger group of patients. The main therapeutic indication for Sotatercept is pulmonary arterial hypertension (PAH), particularly in patients who are newly diagnosed and at intermediate or high risk of disease progression. At the molecular level, Sotatercept works by binding to certain proteins that regulate cell growth, which helps to reduce the abnormal blood vessel growth and high blood pressure in the lungs associated with 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 disease causes the small arteries in the lungs to become narrow 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, dizziness, and swelling in the ankles or legs. Over time, the condition can worsen, leading to more severe symptoms and complications. The progression of PAH can vary, with some individuals experiencing rapid worsening, while others may have a slower progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509139-16-00Protocol codeA011-13Estimated enrolment459 patientsSponsorAcceleron Pharma Inc.

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