A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

Study acronym: SOTERIA

StatusRecruiting

PhasePhase 3

SponsorMerck Sharp & Dohme LLC

Started2021-05-12

View on ClinicalTrials.gov ↗

Amendment history

2026-09-05

Study Status, Contacts/Locations v32

Study sites135→136

2026-08-27

Study Status, Contacts/Locations v31

Study sites134→135

2026-08-20

Study Status, Contacts/Locations v30

Trial sites expanded: 78 → 134 locations

2026-08-14

Study Status, Contacts/Locations v29

Trial sites reduced: 132 → 78 locations

2026-08-07

Study Status, Contacts/Locations v28

Trial sites expanded: 129 → 132 locations

Show 5 earlier versions

2026-07-30

Study Status, Contacts/Locations v27

Study sitesdetails revised at 2 of 129 sites

2026-07-24

Study Status, Contacts/Locations v26

Study sites128→129

2026-07-15

Study Status, Contacts/Locations v25

Study sites127→128

2026-07-08

Study Status, Contacts/Locations v24

Study sites126→127

2026-07-01

Study Status, Contacts/Locations v23

Study sitesdetails revised at 3 of 126 sites

2026-06-25

Study Status, Contacts/Locations v22

Trial sites expanded: 120 → 126 locations

2026-06-18

Study Status, Contacts/Locations v21

Study sites119→120

2026-06-11

Study Status, Contacts/Locations v20

Trial sites expanded: 116 → 119 locations

2026-06-05

Study Status, Contacts/Locations v19

Study sites115→116

2026-05-28

Study Status, Contacts/Locations v18

Study sitesdetails revised at 2 of 115 sites

2026-05-21

Study Status, Contacts/Locations v17

Trial sites expanded: 112 → 115 locations

2026-05-15

Study Status, Contacts/Locations v16

Trial sites expanded: 107 → 112 locations

2026-05-08

Study Status, Contacts/Locations v15

Trial sites expanded: 101 → 107 locations

2026-04-30

Study Status, Contacts/Locations v14

Trial sites expanded: 93 → 101 locations

2026-04-16

Study Status, Contacts/Locations v13

Trial sites expanded: 85 → 93 locations

2026-04-02

Study Status, Contacts/Locations v12

Trial sites expanded: 81 → 85 locations

2026-03-25

Study Status, Contacts/Locations v11

Study sites63→81

2026-03-05

Study Status, Contacts/Locations v10

Study sites52→63

2026-02-25

Study Identification, Study Status, Contacts/Locations v9

Study sites46→52

2026-02-18

Study Status v8

Re-verified, no change to tracked fields

2026-02-17

Study Status, Contacts/Locations v7

Study sites42→46

2026-02-11

Study Status, Contacts/Locations v6

Study sites37→42

2026-02-04

Study Identification, Study Status, Contacts/Locations v5

Study sites28→37

2026-01-29

Study Status, Contacts/Locations v4

Study sites23→28

2026-01-16

Study Status, Contacts/Locations v3

Study sites11→23

2025-12-17

Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, References v2

Start date2025-11-11→2021-05-12

Study sites6→11

Eligibility criteria+492 characters

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: Has completed ~~the~~their ~~MK-7962-004~~current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early 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: The main exclusion criteria include but are not limited to the following: Did not participate in a sotatercept PAH parent study Missed more than the equiv [...] [...]

Secondary endpoints5 entries, revised

Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modiﬁed New York Heart Association/ World Health Organization Classiﬁcation of Functional Status (WHO FC)

Primary endpoints8 entries, revised

Laboratory parameters (Chemistry): Concentration of ~~Blood Urea,~~ Creatinine, Total Bilirubin, ~~Direct Bilirubin, AST, ALT, ALP, Sodium, Potassium, Chloride, Calcium, Phosphorous, Glucose, Magnesium, Carbon Dioxide,~~ and ~~Albumin~~Alanine Aminotransferase (ALT) Laboratory parameters (Hematology): Concentration of ~~Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin,~~Platelets and ~~Hematocrit~~Hemoglobin

Study description+190 characters

~~Participants~~LTFU ~~eligible~~PAH ~~to enroll in this~~sotatercept study ~~will have participated in and completed the requirements of the~~ MK-7962-004 ~~Amendment~~(Obsolete 07Identifier: orNCT04796337) ~~later~~has been incorporated into the current MK-7962-038 (~~NCT04796337~~NCT07218029) study for administrative reasons. The MK-7962-004 study is no longer enrolling participants and will be formally closed. Only those who participated in MK-7962-004 may be eligible to continue into MK-7962-038.

Publicationsdetails revised at 1 of 1 entry

2025-12-03

Not Yet Recruiting→Recruiting Study Status, Study Description, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2025-11-14→confirmed 2025-11-11

Study sites0→6

2025-10-16

Original filing

Merck (MSD)

401 trials monitored

See 24 trials at risk

Hypertension

1,786 trials monitored

See 77 trials at risk

Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse. 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.

Trial Details

NCT Number	NCT07218029
Lead Sponsor	Merck Sharp & Dohme LLC
Conditions	Pulmonary Arterial Hypertension
Enrollment	815 participants
Start Date	2021-05-12
Primary Completion	2028-12-07 (estimated)
Study Completion	2028-12-07 (estimated)
Updated on ClinicalTrials.gov	2026-10-01