Extension Study of Sotatercept for the Treatment of Cpc-PH due to HFpE

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Double-blind, Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF)

• IRAS ID

  1011309

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06814145

• Research summary

  This trial focuses on combined postcapillary and precapillary pulmonary hypertension (Cpc-PH) that is caused by heart failure with preserved ejection fraction (HFpEF). HFpEF is a type of heart failure where the heart muscle becomes stiff and does not relax properly, leading to increased pressure in the blood vessels of the lungs.
  Sotatercept is a targeted therapy, which works on certain proteins that play a role in causing Cpc-PH. This is an extension study meaning participants who took part in a certain trial on sotatercept for Cpc-PH may be able to join. The main goal of this extension study is to learn about the long-term safety of sotatercept and if participants tolerate it over a longer period of time.
  About 130 participants aged 18+ with Cpc-PH caused by HFpEF will be in this trial, they will:
  • Have finished treatment, tests, and procedures in the parent trial
  • Can safely enrol in the new trial
  • Do not have certain health problems such as certain liver diseases
  Everyone in this trial will receive sotatercept as an injection under the skin. Participants will receive the injections every 3 weeks for up to 3 and a half years. Researchers will assign participants to take either a low or a high dose of sotatercept, based on the trial treatment and dose level they received in the parent trial. Researchers may raise or lower a participant’s dose level of sotatercept, if needed.
  During the trial, participants may:
  • Have urine and blood tests and physical examinations
  • Have tests to check their heart (echocardiograms) and see how the heart and lungs work (right heart catheterisation)
  • Have tests to see how far they can walk in 6 minutes without needing extra oxygen or having to rest

  Neither the participants in the trial nor the researchers will know the dose of sotatercept a participant is receiving. Participants may be in this trial for about 3 years and 10 months.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  25/EM/0050

• Date of REC Opinion

  16 Apr 2025

• REC opinion

  Further Information Favourable Opinion