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

Verified siteRegistered drugNo placebo
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What is this trial about?

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

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.

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

    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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

4 criteria

  • 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
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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.

What is already known about the treatment

Sotatercept – Sotatercept is an investigational medication being studied for the treatment of Pulmonary Arterial Hypertension (PAH), a condition where blood pressure in the arteries of the lungs becomes abnormally high. This medication is administered as an injection and is designed to be added to existing PAH treatments to provide additional benefit. Sotatercept works at the molecular level by blocking certain proteins that cause the walls of lung blood vessels to thicken and narrow, helping to restore normal blood vessel function and reduce pressure in the lungs. It belongs to a class of drugs called activin signaling inhibitors, which target specific growth pathways involved in blood vessel remodeling.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521970-33-00Protocol codeMK-7962-038Estimated enrolment661 patientsSponsorMerck Sharp & Dohme LLC

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