An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
Sponsors
Source
Merck Sharp & Dohme LLC
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
Yes
Is Fda Regulated Device
No
Brief Summary
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.
Detailed Description
LTFU PAH sotatercept study MK-7962-004 (Obsolete Identifier: NCT04796337) has been
incorporated into the current MK-7962-038 (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.
Overall Status
Recruiting
Start Date
2021-05-12
Completion Date
2028-12-07
Primary Completion Date
2028-12-07
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Number of Participants Who Experience an Adverse Event (AE) |
Up to approximately 90 months |
|
Number of Participants Who Discontinue Study Treatment Due to an AE |
Up to approximately 86 months |
|
Number of Participants with Detectable Anti-Drug Antibodies (ADAs) |
Up to approximately 88 months |
|
Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin |
Up to approximately 88 months |
|
Laboratory parameters (Chemistry): Concentration of Creatinine, Total Bilirubin, and Alanine Aminotransferase (ALT) |
Up to approximately 86 months |
|
Change From Baseline in Body Weight |
Baseline and up to approximately 86 months |
|
Change From Baseline in Blood Pressure |
Baseline and up to approximately 86 months |
|
Change From Baseline in Electrocardiogram (ECG) |
Baseline and up to approximately 86 months |
Secondary Outcome
Measure |
Time Frame |
|
Change From Baseline in 6-Minute Walk Distance (6MWD) |
Baseline and up to approximately 48 months |
|
Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels |
Baseline and up to approximately 48 months |
|
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) |
Baseline and up to approximately 48 months |
|
Change From Baseline in Pulmonary Vascular Resistance (PVR) |
Baseline and up to approximately 48 months |
|
Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator |
Baseline and up to approximately 48 months |
Enrollment
815
Condition
Intervention
Intervention Type
Biological
Intervention Name
Description
Sotatercept SC injection every 3 weeks
Arm Group Label
Sotatercept
Other Name
MK-7962
ACE-011
ActRIIA-IgG1Fc
WINREVAIR®
Eligibility
Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has completed their 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 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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Medical Director |
Study Director |
Merck Sharp & Dohme LLC |
Overall Contact
Last Name
Toll Free Number
Phone
1-888-577-8839
Trialsites@msd.com
Location
Facility |
Status |
Contact |
|
Pulmonary Associates, PA ( Site 1008) Phoenix 5308655 Arizona 5551752 85032 United States |
Recruiting |
Last Name: Study Coordinator Phone: 602-346-4747 |
|
University of California San Diego Health ( Site 1002) La Jolla 5363943 California 5332921 92039 United States |
Recruiting |
Last Name: Study Coordinator Phone: 858-657-7150 |
|
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019) San Francisco 5391959 California 5332921 94143 United States |
Recruiting |
Last Name: Study Coordinator Phone: 415-514-0000 |
|
Jeffrey S. Sager, MD Medical Corporation ( Site 1060) Santa Barbara 5392952 California 5332921 93105-5316 United States |
Recruiting |
Last Name: Study Coordinator Phone: 805-845-1500 |
|
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028) Torrance 5403022 California 5332921 90502 United States |
Recruiting |
Last Name: Study Coordinator Phone: 310-222-3560 |
|
University of Colorado Hospital ( Site 1013) Aurora 5412347 Colorado 5417618 80045 United States |
Recruiting |
Last Name: Study Coordinator Phone: 720-848-5300 |
|
Mayo Clinic Jacksonville ( Site 1045) Jacksonville 4160021 Florida 4155751 32224 United States |
Recruiting |
Last Name: Study Coordinator Phone: 904-953-2000 |
|
University of Kansas Medical Center ( Site 1020) Kansas City 4273837 Kansas 4273857 66160 United States |
Recruiting |
Last Name: Study Coordinator Phone: 913-588-3855 |
|
Norton Pulmonary Specialists ( Site 1066) Louisville 4299276 Kentucky 6254925 40202 United States |
Recruiting |
Last Name: Study Coordinator Phone: 502-587-8000 |
|
Tufts Medical Center ( Site 1012) Boston 4930956 Massachusetts 6254926 02111 United States |
Recruiting |
Last Name: Study Coordinator Phone: 617-636-6304 |
|
Weill Cornell Medical Center ( Site 1046) New York 5128581 New York 5128638 10021 United States |
Recruiting |
Last Name: Study Coordinator Phone: 646-962-5555 |
|
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001) Cincinnati 4508722 Ohio 5165418 45219 United States |
Recruiting |
Last Name: Study Coordinator Phone: 513-585-1777 |
|
University of Cincinnati Medical Center ( Site 1035) Cincinnati 4508722 Ohio 5165418 45219 United States |
Recruiting |
Last Name: Study Coordinator Phone: 513-558-4831 |
|
Oregon Health & Science University ( Site 1054) Portland 5746545 Oregon 5744337 97239 United States |
Recruiting |
Last Name: Study Coordinator Phone: 503-494-8311 |
|
John Hunter Hospital ( Site 1101) New Lambton Heights 10103866 New South Wales 2155400 2305 Australia |
Recruiting |
Last Name: Study Coordinator Phone: +61249214095 |
|
Vseobecna fakultni nemocnice v Praze ( Site 2201) Prague 3067696 128 08 Czechia |
Recruiting |
Last Name: Study Coordinator Phone: +420224962629 |
|
Rigshospitalet ( Site 3802) København Ø 11746747 Capital Region 6418538 2100 Denmark |
Recruiting |
Last Name: Study Coordinator Phone: +4535453545 |
|
Aarhus Universitetshospital, Skejby ( Site 3801) Aarhus 2624652 Central Jutland 6418539 8200 Denmark |
Recruiting |
Last Name: Study Coordinator Phone: +45450000 |
|
CHU Angers ( Site 1313) Angers 3037656 Maine-et-Loire 49100 France |
Recruiting |
Last Name: Study Coordinator Phone: +33241353695 |
|
Radboud University Nijmegen Medical Centre ( Site 2605) Nijmegen 2750053 Gelderland 2755634 6525 GA Netherlands |
Recruiting |
Last Name: Study Coordinator Phone: +31243611111 |
|
Amsterdam UMC, locatie VUmc ( Site 2601) Amsterdam 2759794 North Holland 2749879 1081 HV Netherlands |
Recruiting |
Last Name: Study Coordinator Phone: +31204444074 |
|
Waikato Hospital ( Site 2702) Hamilton 2190324 Waikato Region 2180293 3240 New Zealand |
Recruiting |
Last Name: Study Coordinator Phone: +6478398899 |
|
Gachon University Gil Medical Center ( Site 3103) Incheon 1843564 21565 South Korea |
Active, not recruiting | |
|
Severance Hospital, Yonsei University Health System ( Site 3101) Seoul 1835848 03722 South Korea |
Active, not recruiting | |
|
Samsung Medical Center ( Site 3106) Seoul 1835848 06351 South Korea |
Active, not recruiting | |
|
Hospital Universitario de Son Espases ( Site 1611) Palma de Mallorca 2512989 Balearic Islands 2521383 07120 Spain |
Recruiting |
Last Name: Study Coordinator Phone: +34871206780 |
|
Hospital Universitario Marques de Valdecilla ( Site 1601) Santander 3109718 Cantabria 3336898 39008 Spain |
Recruiting |
Last Name: Study Coordinator Phone: +34942203565 |
|
Hospital Universitario 12 de Octubre ( Site 1603) Madrid 3117735 Madrid, Comunidad de 28041 Spain |
Recruiting |
Last Name: Study Coordinator Phone: +34917792642 |
|
Hospital General Universitario Ramon y Cajal ( Site 1609) Madrid 3117735 28048 Spain |
Recruiting |
Last Name: Study Coordinator Phone: +34629239978 |
|
Sahlgrenska Universitetssjukhuset ( Site 3201) Gothenburg 2711537 Västra Götaland County 3337386 41346 Sweden |
Recruiting |
Last Name: Study Coordinator Phone: +46313421000 |
|
Kaohsiung Veteran General Hospital ( Site 3702) Kaohsiung City 1673820 813 Taiwan |
Active, not recruiting | |
|
National Cheng Kung University Hospital ( Site 3703) Tainan 1668355 704302 Taiwan |
Active, not recruiting | |
|
Papworth Hospital NHS Foundation Trust ( Site 1208) Cambridge 2653941 Cambridgeshire CB2 0AY United Kingdom |
Recruiting |
Last Name: Study Coordinator Phone: +441223639517 |
|
Royal Brompton Hospital ( Site 1206) London 2643743 London, City of SW3 6NP United Kingdom |
Recruiting |
Last Name: Study Coordinator Phone: +442073518905 |
|
Hammersmith Hospital ( Site 1203) London 2643743 London, City of W12 0HS United Kingdom |
Recruiting |
Last Name: Study Coordinator Phone: +442033136713 |
|
Freeman Hospital ( Site 1205) Newcastle upon Tyne 2641673 NE7 7DN United Kingdom |
Active, not recruiting | |
|
Royal Hallamshire Hospital ( Site 1207) Sheffield 2638077 S10 2JF United Kingdom |
Recruiting |
Last Name: Study Coordinator Phone: +441142712566 |
Location Countries
Country
Australia
Czechia
Denmark
France
Netherlands
New Zealand
South Korea
Spain
Sweden
Taiwan
United Kingdom
United States
Verification Date
2026-02-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Secondary Id
2025-521970-33-00
U1111-1321-4943
MK-7962-038
MK-7962-004
Number Of Arms
1
Intervention Browse
Mesh Term
ACE-011
Arm Group
Arm Group Label
Sotatercept
Arm Group Type
Experimental
Description
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.
Results Reference
Citation
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.
PMID
39978862
Firstreceived Results Date
N/A
Acronym
SOTERIA
Nct Alias
NCT04796337
Patient Data
Sharing Ipd
Yes
Ipd Description
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Ipd Url
https://externaldatasharing-msd.com/
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
October 7, 2025
Study First Submitted Qc
October 16, 2025
Study First Posted
October 20, 2025
Last Update Submitted
February 4, 2026
Last Update Submitted Qc
February 4, 2026
Last Update Posted
February 5, 2026
ClinicalTrials.gov processed this data on February 09, 2026
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.