A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
NCT ID: NCT07218029
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
815 participants
INTERVENTIONAL
2021-05-12
2028-12-07
Brief Summary
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Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.
This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sotatercept
Participants enrolling from blinded PAH sotatercept studies will begin sotatercept at a dose of 0.3 mg/kg subcutaneous (SC) injection and can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study. Participants enrolling from unblinded PAH sotatercept studies will continue sotatercept at their current dose and, if at a dose \<0.7 mg/kg, can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study.
Sotatercept
Sotatercept SC injection every 3 weeks
Interventions
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Sotatercept
Sotatercept SC injection every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
* Must have the ability to understand and provide documented informed consent
Exclusion Criteria
* Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
* Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
* Is a female who is pregnant or breastfeeding
* Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
* Is currently enrolled in another investigational product study other than a sotatercept study
* Is incapacitated
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, United States
University of California San Diego Health ( Site 1002)
La Jolla, California, United States
University of Colorado Hospital ( Site 1013)
Aurora, Colorado, United States
Norton Pulmonary Specialists ( Site 1066)
Louisville, Kentucky, United States
Weill Cornell Medical Center ( Site 1046)
New York, New York, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati, Ohio, United States
Severance Hospital, Yonsei University Health System ( Site 3101)
Seoul, , South Korea
Samsung Medical Center ( Site 3106)
Seoul, , South Korea
National Cheng Kung University Hospital ( Site 3703)
Tainan, , Taiwan
Papworth Hospital NHS Foundation Trust ( Site 1208)
Cambridge, Cambridgeshire, United Kingdom
Hammersmith Hospital ( Site 1203)
London, London, City of, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
References
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Preston IR, Badesch D, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Humbert M, McLaughlin VV, Waxman AB, Manimaran S, Mikhailova E, Reddy M, Lau A, de Oliveira Pena J, Souza R. A long-term follow-up study of sotatercept for treatment of pulmonary arterial hypertension: interim results of SOTERIA. Eur Respir J. 2025 Jul 24;66(1):2401435. doi: 10.1183/13993003.01435-2024. Print 2025 Jul.
Related Links
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Merck Clinical Trials Information
Other Identifiers
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7962-038
Identifier Type: -
Identifier Source: org_study_id
2025-521970-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1321-4943
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-7962-038
Identifier Type: OTHER
Identifier Source: secondary_id
NCT04796337
Identifier Type: -
Identifier Source: nct_alias