Clinical trial of sotatercept in adults with PAH

• Research type

  Research Study

• Full title

  An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)

• IRAS ID

  1012109

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT04796337

• Research summary

  Researchers are looking for more ways to treat pulmonary arterial hypertension (PAH). Some standard treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse.

  This trial looks at adding sotatercept to standard PAH treatment. Sotatercept is a trial medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.

  The goal is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer time.

  No more than 815 people with PAH aged 18 years or older will be in the trial if they meet certain criteria, including if they:
  • Have participated in another trial giving sotatercept
  • Are not pregnant or breastfeeding

  People who are receiving sotatercept on another trial will enter this trial and continue to receive sotatercept and keep taking their current, standard treatment for PAH. Sotatercept is given as an injection under the skin every 3 weeks.

  Researchers will assign people a dose level of sotatercept based on the dose level they are already receiving in the other trial. People who received a lower dose level may switch to a higher dose level. Researchers will follow-up with people who stop taking sotatercept in this part of the trial.

  Both the people in the trial and the researchers will know the treatment each person gets (open-label trial).

  A person may be in this trial for up to 3 years.

  During the trial, people may:
  • Have blood tests, physical exams, and heart tests called electrocardiograms and echocardiograms
  • Answer questions about how they are feeling
  • Have tests to see how far they can walk in 6 minutes
  • Have right heart catheterisation, where doctors guide a flexible tube through a blood vessel and into the heart to measure blood pressure in the heart and lungs

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  25/NE/0158

• Date of REC Opinion

  30 Sep 2025

• REC opinion

  Further Information Favourable Opinion