Sotatercept for Pulmonary Arterial Hypertension
(ZENITH Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing sotatercept added to current treatments for patients with severe PAH who are at high risk of death. The goal is to see if it can lower lung blood pressure and improve patient outcomes. Sotatercept, which modulates bone morphogenic protein receptor type 2 (BMPR2) signaling, showed promising results in earlier studies.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but it requires participants to be on stable doses of their current pulmonary arterial hypertension (PAH) therapies for at least 30 days before joining. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug sotatercept for pulmonary arterial hypertension?
Is sotatercept safe for humans?
What makes the drug sotatercept unique for treating pulmonary arterial hypertension?
Sotatercept is unique because it is a fusion protein that works by trapping activins and growth differentiation factors, which helps restore balance in signaling pathways involved in pulmonary arterial hypertension. This mechanism is different from other treatments and aims to address the underlying causes of the disease.12346
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Eligibility Criteria
This trial is for adults with severe Pulmonary Arterial Hypertension (WHO FC III or IV) who are at high risk of mortality. They must be on stable PAH medication, not pregnant, and willing to use contraception. Exclusions include certain heart conditions, recent strokes, liver issues, untreated sleep apnea, and previous reactions to sotatercept.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sotatercept or placebo added to maximum tolerated background PAH therapy, administered subcutaneously every 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of PAH symptoms and health outcomes
Treatment Details
Interventions
- Placebo
- Sotatercept
Find a Clinic Near You
Who Is Running the Clinical Trial?
Acceleron Pharma Inc.
Lead Sponsor
Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Lead Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Lead Sponsor