Study of Sotatercept for People with Pulmonary Arterial Hypertension

2 1 1 1

What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Fondazione Toscana Gabriele Monasterio Pisa Italy
CHU Gabriel-Montpied Clermont Ferrand France
Hospital Universitario 12 De Octubre Madrid Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Gottsegen National Cardiovascular Center Budapest Hungary
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Degli Studi Di Verona Verona Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Stichting Radboud University Medical Center Nijmegen The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
IRCCS Ospedale Policlinico San Martino Genoa Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Servei De Salut De Les Illes Balears Palma Spain
University Of Szeged Szeged Hungary
Uorrijakso Mtlcpdo Clwfnv Hnusuettnnvsmbgzn Hamburg Germany
Hnvkjfmu Upaxieuxlaazu Mrejeqm Dl Vzqorntxmj Santander Spain
Cuubwv Hgqsvaccmbs Uxgcxpdlfiauy Dt Dgiwx Dijon France
Alwpbqxkop Paxiiezn Hlpstbca Dq Mdleegppd Marseille France
Alfkeuw Ostudfzztkg Uwbkspwaxcdvq Cgyqbcuzjvge Dsbts Sxxkpz E Dkgir Sbrvush Dj Tzfjsq Turin Italy
Areqzri Uzvgs Sdixxfstx Lpyqad Dz Blauxjr Bologna Italy
Ubhgafmgnj Dzfax Srmtl Dk Rcyw Lk Sgztmscb Rome Italy
Fdjlsbokz Pjxp Lk Ivjwspqkkvmht Bxqjvjhgp Dla Hfntgnyj Uxlwcjxnviuon Lt Prm Madrid Spain
Hhegkyml Vfwr dxlsdikw Barcelona Spain
Krbnvfsab Sxixxxw Svnsxzkpwvaakkf ik Jczg Pmhgg Iz Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
18.11.2024
France France
Not recruiting
18.11.2024
Germany Germany
Not recruiting
18.11.2024
Hungary Hungary
Not recruiting
18.11.2024
Italy Italy
Not recruiting
18.11.2024
Poland Poland
Not recruiting
18.11.2024
Spain Spain
Not recruiting
18.11.2024
The Netherlands The Netherlands
Not recruiting
18.11.2024

Trial locations

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.

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 ID:
2024-512278-92-00
Protocol code:
MK-7962-024
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A study to evaluate the effectiveness and safety of REGN13335 in adults with pulmonary arterial hypertension

    Recruiting

    2 1
    Investigated diseases:
    Belgium Czechia France Germany Latvia Poland +1
  • A Study of ROC-101 Hydrochloride for Patients with Pulmonary Arterial Hypertension and Pulmonary Hypertension Associated with Interstitial Lung Disease

    Recruiting

    2 1 1
    Investigated drugs:
    France Germany Italy Latvia Poland Spain