Clinical trial of sotatercept using different dosing methods for PAH

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care

• IRAS ID

  1010520

• 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).

  Standard PAH treatment includes taking medicines that help lower blood pressure in the lungs and improve blood flow through the heart and lungs. Sotatercept is a trial medicine that can be used to treat PAH and is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH. Sotatercept can be given with other standard treatments. The dose (amount) of sotatercept is given based on the person’s exact weight (weight-based doses).

  Researchers want to know if it is safe to give a dose of sotatercept based on the weight range a person is in (weight-banded doses).

  The goal of the trial is to learn:
  • What happens to different doses of sotatercept in a person’s body over time when given as weight-banded doses compared to weight-based doses
  • About the safety of sotatercept and if people tolerate it

  About 160 people with PAH at least 18 years old will be in the trial and:
  • Have taken standard PAH treatments for at least 3 months before starting the trial
  • Do not have certain types of heart disease or certain health conditions

  Everyone will receive sotatercept as an injection under the skin once every 3 weeks for about 6 months. People will also continue standard PAH treatments.

  People will be assigned by equal chance to:
  • Group 1 (weight-based doses) - Dose of sotatercept based on their exact weight.
  • Group 2 (weight-banded doses) - Put into 1 of 5 groups based on their weight and receive a dose of sotatercept based on the weight group they are in. The dose of sotatercept goes up as the weight groups go up.

  Both groups will receive a lower first dose of sotatercept and then the dose will slowly increase until the target weight-based or weight-banded dose is reached. Researchers will lower a person’s dose if they cannot tolerate it.

  People may be in the trial for up to 9 months.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  24/LO/0612

• Date of REC Opinion

  14 Oct 2024

• REC opinion

  Further Information Favourable Opinion