Investigating Sotatercept for Treating Pulmonary Arterial Hypertension
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
PHASE2 · Merck Sharp & Dohme LLC · NCT06925750
This study is testing a new medication called sotatercept to see how well it works and how patients with pulmonary arterial hypertension tolerate it compared to standard treatments.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC (industry) |
| Locations | 2 sites (London, London, City Of and 1 other locations) |
| Trial ID | NCT06925750 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and tolerability of sotatercept, a medication designed for pulmonary arterial hypertension (PAH), in patients who previously participated in a related study. Participants will receive weight-banded doses of sotatercept over an extended period. The study aims to determine how well patients tolerate this dosing approach compared to traditional methods. It builds on findings from an earlier study to explore new treatment options for PAH.
Who should consider this trial
Good fit: Ideal candidates are individuals who have completed the previous LIGHTRAY study and have not started treatment with commercially available sotatercept.
Not a fit: Patients currently receiving other activin signaling inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new and effective treatment option for patients with pulmonary arterial hypertension.
How similar studies have performed: Previous studies involving sotatercept have shown promising results, indicating potential for success in this extension study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has completed the treatment period of study MK-7962-024 (LIGHTRAY) (including Visit 11) on study intervention, did not discontinue study intervention, and is able to safely enroll into MK-7962-031 (LIGHTRAY EXTENSION) * Has not started treatment with commercially available sotatercept Exclusion Criteria: The main exclusion criteria include but are not limited to the following: - Has current exposure or is planning to begin treatment with an activin signaling inhibitor (other than sotatercept)
Where this trial is running
London, London, City Of and 1 other locations
- Hammersmith Hospital ( Site 1801) — London, London, City Of, United Kingdom (RECRUITING)
- Golden Jubilee National Hospital ( Site 1800) — Glasgow City, Scotland, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Arterial Hypertension