Extension Study of Sotatercept for Weight-banded Approach in PAH

• Research type

  Research Study

• Full title

  An Open-label Extension Study to Evaluate Safety and Tolerability of Sotatercept (MK-7962) Administered Using a Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care

• IRAS ID

  1011310

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers are looking for other ways to treat pulmonary arterial hypertension (PAH).

  The standard (usual) treatment for PAH includes taking medicines that help lower blood pressure in the lungs and improve blood flow through the heart and lungs. Sotatercept is a study medicine that is designed to treat PAH. It can be given with standard treatments. Sotatercept is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.

  This is an extension study, which means people who took part in the parent study (MK-7962-024 (LIGHTRAY)) may be able to join this study.

  The main goal of this study is to learn about the safety of weight-banded doses of sotatercept and if people tolerate it over a longer period of time.

  About 130 people with PAH at least 18 years old will be in this study and:
  • Have finished treatment, tests, and procedures in the parent study
  • Not have taken a certain medicine for low red blood cells (anaemia) and will not take it while in this study

  Everyone in this study will receive sotatercept as weight-banded doses. It will be given as an injection under the skin once every 3 weeks. People may receive treatment for up to 2 and half years.

  Researchers will put people into 1 of 5 groups based on their weight (also known as a weight-band).

  Researchers will lower a person’s dose if they cannot tolerate it. If a person’s weight changes, they may be moved to a different weight group. Their dose may be delayed or increased depending on the weight-banded dosing for the new weight group. With researcher guidance, some people may have the option to give themselves their dose.

  People may be in the study for up to about 2 years and 9 months.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  25/LO/0048

• Date of REC Opinion

  21 Mar 2025

• REC opinion

  Further Information Favourable Opinion