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

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)

Lead Sponsor

Merck Sharp & Dohme LLC

Source

Merck Sharp & Dohme LLC

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

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

Pulmonary Arterial Hypertension

Intervention

Intervention Type

Biological

Intervention Name

Sotatercept

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

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

Email

Trialsites@msd.com

Location

Facility	Status	Contact
Pulmonary Associates, PA ( Site 1008) Phoenix Arizona 85032 United States	Recruiting	Last Name: Study Coordinator Phone: 602-346-4747
University of California San Diego Health ( Site 1002) La Jolla California 92039 United States	Recruiting	Last Name: Study Coordinator Phone: 858-657-7150
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019) San Francisco California 94143 United States	Recruiting	Last Name: Study Coordinator Phone: 415-514-0000
Jeffrey S. Sager, MD Medical Corporation ( Site 1060) Santa Barbara California 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 California 90502 United States	Recruiting	Last Name: Study Coordinator Phone: 310-222-3560
University of Colorado Hospital ( Site 1013) Aurora Colorado 80045 United States	Recruiting	Last Name: Study Coordinator Phone: 720-848-5300
Mayo Clinic Jacksonville ( Site 1045) Jacksonville Florida 32224 United States	Recruiting	Last Name: Study Coordinator Phone: 904-953-2000
University of Kansas Medical Center ( Site 1020) Kansas City Kansas 66160 United States	Recruiting	Last Name: Study Coordinator Phone: 913-588-3855
Norton Pulmonary Specialists ( Site 1066) Louisville Kentucky 40202 United States	Recruiting	Last Name: Study Coordinator Phone: 502-587-8000
Tufts Medical Center ( Site 1012) Boston Massachusetts 02111 United States	Recruiting	Last Name: Study Coordinator Phone: 617-636-6304
University Of Nebraska Medical Center ( Site 1053) Omaha Nebraska 68198-5990 United States	Recruiting	Last Name: Study Coordinator Phone: 402-552-2000
Weill Cornell Medical Center ( Site 1046) New York New York 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 Ohio 45219 United States	Recruiting	Last Name: Study Coordinator Phone: 513-585-1777
University of Cincinnati Medical Center ( Site 1035) Cincinnati Ohio 45219 United States	Recruiting	Last Name: Study Coordinator Phone: 513-558-4831
Ohio State University Wexner Medical Center ( Site 1032) Columbus Ohio 43210 United States	Recruiting	Last Name: Study Coordinator Phone: 614-293-4967
Oregon Health & Science University ( Site 1054) Portland Oregon 97239 United States	Recruiting	Last Name: Study Coordinator Phone: 503-494-8311
John Hunter Hospital ( Site 1101) New Lambton Heights New South Wales 2305 Australia	Active, not recruiting
Fiona Stanley Hospital ( Site 1103) Murdoch Western Australia 6150 Australia	Recruiting	Last Name: Study Coordinator Phone: +61861521561
UZ Leuven ( Site 1401) Leuven Vlaams-Brabant 3000 Belgium	Recruiting	Last Name: Study Coordinator Phone: +32 16 34 68 33
Institut Klinicke a Experimentalni Mediciny ( Site 2202) Prague Praha 4 140 21 Czechia	Recruiting	Last Name: Study Coordinator Phone: +420236053006
Vseobecna fakultni nemocnice v Praze ( Site 2201) Prague 128 08 Czechia	Recruiting	Last Name: Study Coordinator Phone: +420224962629
Rigshospitalet ( Site 3802) København Ø Capital Region 2100 Denmark	Recruiting	Last Name: Study Coordinator Phone: +4535453545
Aarhus Universitetshospital, Skejby ( Site 3801) Aarhus Central Jutland 8200 Denmark	Recruiting	Last Name: Study Coordinator Phone: +45450000
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311) Nice Alpes-Maritimes 06300 France	Recruiting	Last Name: Study Coordinator Phone: +33492037746
Nouvel Hôpital Civil (NHC) ( Site 1307) Strasbourg Bas-Rhin 67000 France	Recruiting	Last Name: Study Coordinator Phone: +33369551145
Hopital Cavale Blanche ( Site 1314) Brest Finistere 29609 France	Recruiting	Last Name: Study Coordinator Phone: +33298347600
Hopital Larrey ( Site 1315) Toulouse Haute-Garonne 31400 France	Recruiting	Last Name: Study Coordinator Phone: +33561772233
CHU de Grenoble Hopital Nord ( Site 1303) La Tronche Isere 38700 France	Recruiting	Last Name: Study Coordinator Phone: +33476766823
Hopital Nord Laennec ( Site 1309) Saint-Herblain Loire-Atlantique 44800 France	Recruiting	Last Name: Study Coordinator Phone: +33253482707
CHU Angers ( Site 1313) Angers Maine-et-Loire 49100 France	Recruiting	Last Name: Study Coordinator Phone: +33241353695
Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique ( Site 1302) Saint-Étienne-de-Montluc Pays de la Loire Region 42055 France	Recruiting	Last Name: Study Coordinator Phone: +33477827770
Hôpital Louis Pradel ( Site 1317) Lyon Rhone 69677 France	Recruiting	Last Name: Study Coordinator Phone: +33427857700
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1304) Le Kremlin-Bicêtre Val-de-Marne 94275 France	Recruiting	Last Name: Study Coordinator Phone: +33145217976
CHU de la Miletrie Poitiers ( Site 1316) Poitiers Vienne 86021 France	Recruiting	Last Name: Study Coordinator Phone: +33549444689
Rabin Medical Center ( Site 1703) Petah Tikva 4941492 Israel	Recruiting	Last Name: Study Coordinator Phone: +97239377377
Sheba Medical Center ( Site 1701) Ramat Gan 5265601 Israel	Recruiting	Last Name: Study Coordinator Phone: +97235303030
AOU Policlinico Umberto I ( Site 2402) Rome Roma 00161 Italy	Recruiting	Last Name: Study Coordinator Phone: +390649979051
Radboud University Nijmegen Medical Centre ( Site 2605) Nijmegen Gelderland 6525 GA Netherlands	Recruiting	Last Name: Study Coordinator Phone: +31243611111
Amsterdam UMC, locatie VUmc ( Site 2601) Amsterdam North Holland 1081 HV Netherlands	Recruiting	Last Name: Study Coordinator Phone: +31204444074
Waikato Hospital ( Site 2702) Hamilton Waikato Region 3240 New Zealand	Active, not recruiting
Hospital Garcia de Orta ( Site 3501) Almada Setúbal District 2805-267 Portugal	Recruiting	Last Name: Study Coordinator Phone: +351212940294
Gachon University Gil Medical Center ( Site 3103) Incheon 21565 South Korea	Active, not recruiting
Severance Hospital, Yonsei University Health System ( Site 3101) Seoul 03722 South Korea	Active, not recruiting
Samsung Medical Center ( Site 3106) Seoul 06351 South Korea	Active, not recruiting
Hospital Universitario de Son Espases ( Site 1611) Palma de Mallorca Balearic Islands 07120 Spain	Recruiting	Last Name: Study Coordinator Phone: +34871206780
Hospital Universitario Marques de Valdecilla ( Site 1601) Santander Cantabria 39008 Spain	Recruiting	Last Name: Study Coordinator Phone: +34942203565
Hospital Universitari Vall D Hebron ( Site 1605) Barcelona Catalonia 08035 Spain	Recruiting	Last Name: Study Coordinator Phone: +34 932746107
Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604) Majadahonda Madrid 28222 Spain	Recruiting	Last Name: Study Coordinator Phone: +34911917418
Hospital Universitario 12 de Octubre ( Site 1603) Madrid Madrid, Comunidad de 28041 Spain	Recruiting	Last Name: Study Coordinator Phone: +34917792642
Hospital Clinic de Barcelona ( Site 1602) Barcelona 08036 Spain	Recruiting	Last Name: Study Coordinator Phone: +34932275540
Hospital Universitario La Paz ( Site 1610) Madrid 28046 Spain	Recruiting	Last Name: Study Coordinator Phone: +34917271785
Hospital General Universitario Ramon y Cajal ( Site 1609) Madrid 28048 Spain	Recruiting	Last Name: Study Coordinator Phone: +34629239978
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607) Toledo 45007 Spain	Recruiting	Last Name: Study Coordinator Phone: +34925269200
Sahlgrenska Universitetssjukhuset ( Site 3201) Gothenburg Västra Götaland County 41346 Sweden	Recruiting	Last Name: Study Coordinator Phone: +46313421000
UniversitätsSpital Zürich ( Site 3301) Zurich 8091 Switzerland	Recruiting	Last Name: Study Coordinator Phone: +41 44 255 86 81
Kaohsiung Veteran General Hospital ( Site 3702) Kaohsiung City 813 Taiwan	Active, not recruiting
National Cheng Kung University Hospital ( Site 3703) Tainan 704302 Taiwan	Active, not recruiting
Papworth Hospital NHS Foundation Trust ( Site 1208) Cambridge Cambridgeshire CB2 0AY United Kingdom	Recruiting	Last Name: Study Coordinator Phone: +441223639517
Golden Jubilee National Hospital ( Site 1204) Glasgow Glasgow City G81 4DY United Kingdom	Recruiting	Last Name: Study Coordinator Phone: +441419515000
Royal Brompton Hospital ( Site 1206) London London, City of SW3 6NP United Kingdom	Recruiting	Last Name: Study Coordinator Phone: +442073518905
Hammersmith Hospital ( Site 1203) London London, City of W12 0HS United Kingdom	Recruiting	Last Name: Study Coordinator Phone: +442033136713
Freeman Hospital ( Site 1205) Newcastle upon Tyne NE7 7DN United Kingdom	Active, not recruiting
Royal Hallamshire Hospital ( Site 1207) Sheffield S10 2JF United Kingdom	Recruiting	Last Name: Study Coordinator Phone: +441142712566

Location Countries

Country

Australia

Belgium

Czechia

Denmark

France

Israel

Italy

Netherlands

New Zealand

Portugal

South Korea

Spain

Sweden

Switzerland

Taiwan

United Kingdom

United States

Verification Date

2026-03-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor

Has Expanded Access

Condition Browse

Pulmonary Arterial Hypertension

Secondary Id

2025-521970-33-00

U1111-1321-4943

MK-7962-038

MK-7962-004

Number Of Arms

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

March 5, 2026

Last Update Submitted Qc

March 5, 2026

Last Update Posted

March 9, 2026

ClinicalTrials.gov processed this data on March 11, 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.

ICH GCP | Clinical Trials Registry

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)