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Study of Sotatercept for People with Pulmonary Arterial Hypertension

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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 called Pulmonary Arterial Hypertension (PAH). PAH is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. The study will use a treatment 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 it behaves in the body and how safe it is for people with PAH.

The purpose of the study is to understand how sotatercept is absorbed and processed in the body when given in different ways based on a person's weight. Participants will receive sotatercept through a subcutaneous injection, which means it is injected under the skin. The study will last for 24 weeks, during which participants will receive multiple doses of the medication. Researchers will monitor the levels of sotatercept in the blood and check for any side effects or adverse events that may occur during the treatment period.

By participating in this study, researchers aim to gather important information about the safety and effectiveness of sotatercept for treating PAH. This information could help improve treatment options for people living with this condition. The study will not only look at how the drug is processed in the body but also ensure that it is safe and well-tolerated by participants over the course of the treatment.

The research process

The trial runs in 4 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 informed about the trial's purpose, which is to evaluate the exposure and safety of sotatercept in individuals with pulmonary arterial hypertension (PAH).

    The participant will be randomly assigned to receive sotatercept either through a weight-based or weight-banded dosing approach.

  2. Step 2

    Treatment administration

    The participant will receive sotatercept as a solution for injection administered subcutaneously. This means the medication is injected under the skin.

    The treatment will be given over a period of 24 weeks, with multiple doses administered to reach a steady state.

  3. Step 3

    Monitoring and evaluation

    Throughout the trial, the participant's response to the treatment will be closely monitored. This includes measuring the average serum concentrations of sotatercept to assess its exposure in the body.

    The safety and tolerability of the treatment will also be evaluated by tracking any adverse events experienced by the participant.

  4. Step 4

    Completion of the study

    At the end of the 24-week treatment period, the participant will undergo a final assessment to determine the overall effects of the treatment.

    The study is expected to conclude by June 2026, with all data collected and analyzed to understand the impact of sotatercept on pulmonary arterial hypertension.

Who can join the trial?

6 criteria

  • The patient must have a confirmed diagnosis of **Pulmonary Arterial Hypertension (PAH)**. This is a condition where there is high blood pressure in the arteries of the lungs.
  • The patient must have had a **Right Heart Catheterization**. This is a test that checks the pressure in the heart and lungs.
  • The patient must be diagnosed with **World Health Organization (WHO) Pulmonary Arterial Hypertension (PAH) Group 1**. This includes types like Idiopathic PAH (unknown cause), Heritable PAH (runs in families), Drug/toxin-induced PAH, PAH linked to connective tissue disease, or PAH related to simple congenital heart defects repaired at least 1 year ago.
  • The patient must have **systemic PAH** classified as **WHO Functional Class II or III**. This means the patient has some limitations in physical activity but is comfortable at rest (Class II) or has more noticeable limitations and feels symptoms even with less than ordinary activity (Class III).
  • The patient must be within the age range of adults, which typically means 18 years or older.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent major surgery.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of allergic reactions to similar medications.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients who have used certain medications that might affect the study results.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

Sotatercept (MK-7962) is being studied for its effects on pulmonary arterial hypertension (PAH). It is designed to help manage PAH by potentially improving blood flow in the lungs and reducing the workload on the heart. The trial is examining how the body processes the medication when given in different dosing methods, either based on a person's weight or within a specific weight range. The study also aims to assess the safety and tolerability of sotatercept over a 24-week treatment period.

What is already known about the treatment

Sotatercept – Sotatercept is administered via injection and is currently being studied in clinical trials for its effects on Pulmonary Arterial Hypertension (PAH). It is in the investigational stage, with ongoing research to determine its pharmacokinetics and safety. The main therapeutic indication for sotatercept is the treatment of PAH, a condition characterized by high blood pressure in the arteries of the lungs. At the molecular level, sotatercept works by modulating the signaling pathways involved in the growth and proliferation of cells in the blood vessels, potentially reducing the abnormal cell growth that contributes to PAH. It is classified pharmacologically as a receptor fusion protein, which targets specific pathways to exert its effects.

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 these arteries, which can lead to heart strain and enlargement. Over time, this increased workload can weaken the heart muscle and affect its ability to pump blood efficiently. Symptoms often include shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. The progression of PAH can vary, but it typically involves a gradual worsening of symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512278-92-00Protocol codeMK-7962-024Estimated enrolment252 patientsSponsorMerck Sharp & Dohme LLC

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