Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Sotatercept for Treating Pulmonary Hypertension in Patients with Heart Failure with Preserved Ejection Fraction

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 Hypertension, a condition where there is high blood pressure in the blood vessels that supply the lungs. The specific type of pulmonary hypertension being studied is related to heart failure with preserved ejection fraction, which means the heart pumps normally but is too stiff to fill properly. The treatment being tested is called sotatercept, also known by its code name MK-7962. Sotatercept is a solution for injection and is designed to help manage this condition.

The purpose of this study is to evaluate the long-term safety and tolerability of sotatercept over a period of up to 42 months. Participants in the study will receive sotatercept through subcutaneous injections, which means the medication is injected under the skin. The study will monitor participants for any adverse events, which are unwanted effects that may occur during the treatment. Additionally, the study will assess changes in participants' ability to walk a certain distance in six minutes, as well as changes in their heart function and blood pressure in the lungs over time.

This study is an extension of previous research and aims to provide more information on how well sotatercept works and how safe it is for people with pulmonary hypertension. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the effectiveness of the treatment. The study is expected to continue until 2029, allowing researchers to collect comprehensive data on the long-term effects of sotatercept.

The research process

The trial runs in 7 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, you will be informed about the purpose and procedures involved. This study aims to evaluate the long-term safety and tolerability of sotatercept for the treatment of pulmonary hypertension due to heart failure with preserved ejection fraction.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet the criteria for participation. This includes confirming that you have completed the previous study, MK-7962-007 (CADENCE), without discontinuing the study intervention.

  3. Step 3

    Treatment administration

    You will receive sotatercept as a solution for injection administered subcutaneously (under the skin). The frequency and dosage will be determined by the study protocol and your healthcare provider.

  4. Step 4

    Regular follow-up visits

    Regular follow-up visits will be scheduled to monitor your health and the effects of the treatment. These visits will include assessments of your pulmonary vascular resistance and your ability to walk for six minutes, among other evaluations.

  5. Step 5

    Monitoring for adverse events

    Throughout the study, you will be monitored for any adverse events, which are any unwanted effects that may occur during the treatment. If any adverse events occur, they will be documented, and appropriate measures will be taken.

  6. Step 6

    Long-term evaluation

    The study will continue for up to 42 months, during which your response to the treatment will be evaluated at various intervals, including weeks 48, 126, and 174. This will involve measuring changes in your condition from the start of the study.

  7. Step 7

    Completion of the study

    Upon completion of the study, a final assessment will be conducted to evaluate the overall effects of the treatment and to ensure your well-being.

Who can join the trial?

4 criteria

  • You must have completed the previous study called MK-7962-007 (CADENCE) without stopping the study treatment early and be able to safely join the new study called MK-7962-007 (HARMONIZE).
  • You must have a condition called Pulmonary Hypertension.
  • Both men and women can participate.
  • Participants must be within the age range specified by the study, which includes adults.

Who cannot join the trial?

8 criteria

  • Patients with any other serious medical condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with a history of allergic reactions to the study medication.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients who are unable to comply with the study procedures.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Sotatercept is a medication being studied for its potential to help people with a specific type of high blood pressure in the lungs, known as pulmonary hypertension, which occurs due to heart failure with preserved ejection fraction. This condition involves both the blood vessels in the lungs and the heart. Sotatercept works by targeting certain proteins in the body that are involved in the development of this type of high blood pressure. The goal of using sotatercept in this study is to see if it can safely and effectively reduce the pressure in the lungs and improve heart function over a long period of time.

What is already known about the treatment

Sotatercept – Sotatercept is administered as an injection under the skin and is currently being studied in clinical trials for its potential use in treating pulmonary hypertension, specifically a type that occurs due to heart failure with preserved ejection fraction. This medication is still under investigation, and its long-term safety and tolerability are being evaluated over a period of up to 42 months. Sotatercept works by targeting specific proteins in the body that are involved in blood vessel function, aiming to improve blood flow and reduce the pressure in the lungs. It is classified as a therapeutic agent for pulmonary hypertension, focusing on improving heart and lung function.

Investigated diseases

Pulmonary Hypertension – Pulmonary Hypertension is a condition characterized by high blood pressure in the arteries of 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 dizziness. 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. As the condition advances, it can lead to complications such as right-sided heart failure. Pulmonary Hypertension can be caused by various underlying conditions, including heart and lung diseases.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515773-99-00Protocol codeMK-7962-023Estimated enrolment132 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.