Pulmonary Arterial HypertensionPhase 3NCT05818137

A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020)

A Phase 3 study testing Sotatercept in people with Pulmonary Arterial Hypertension, run by Merck Sharp & Dohme LLC at 17 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This local Phase 3 study is planned to confirm the efficacy and safety in Japanese PAH participants. The primary population of this study is Japanese PAH participants with World Health Organization Functional Class (WHO FC) II or III while the study includes PAH participants with WHO FC I or IV as other populations. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Arterial Hypertension
What is being tested?: Sotatercept
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 17 sitesJapan
Study dates: 10 May 2023to 6 Nov 2025
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of World Health Organization (WHO) pulmonary arterial hypertension (PAH) Group 1 in any of the following subtypes:
Idiopathic PAH
Heritable PAH
Drug/toxin-induced PAH
PAH associated with connective tissue disease
PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
PAH classified as WHO functional class (FC) I or symptomatic PAH classified as WHO FC II to IV
On stable doses of background PAH therapy and diuretics (if applicable) for at least 90 days prior to screening

Who cannot join

Diagnosis of PH WHO Groups 2, 3, 4, or 5
Diagnosis of the following PAH Group 1 subtypes:
Human immunodeficiency virus (HIV)-associated PAH
PAH associated with portal hypertension
Schistosomiasis-associated PAH
PAH with features of significant venous/capillary pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis (PVOD/PCH) involvement

Show all 24Show fewer

Is on the waiting list for lung transplant
Pregnant or breastfeeding women
History of full or partial pneumonectomy
Pulmonary function test (PFT) values of forced vital capacity (FVC) < 60% predicted at the screening visit or within 6 months prior to the screening visit.
Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to the screening visit or planned initiation during the study.
History of more than mild obstructive sleep apnea that is untreated
Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment.
History of restrictive, constrictive, or congestive cardiomyopathy.
History of atrial septostomy within 180 days prior to the screening visit.
Personal or family history of long QT syndrome (LQTS) or sudden cardiac death.
Left ventricular ejection fraction (LVEF) < 45% on historical Echocardiogram (ECHO) within 6 months prior to the screening visit.
Any symptomatic coronary disease events within 6 months prior to the screening visit.
Cerebrovascular accident within 3 months prior to the screening visit.
Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease, mitral stenosis and more than mild aortic valve stenosis.
Prior exposure to sotatercept or luspatercept or history of allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product
Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit
Currently enrolled in or have completed any other investigational product study within 30 days
Weight at the screening is over 85 kg

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Japan17 sites

The University of Tokyo Hospital ( Site 2006)
Bunkyo-ku, Tokyo, 113-8654
Chiba University Hospital ( Site 2003)
Chiba, 260-8677
Kyushu University Hospital ( Site 2015)
Fukuoka, 812-8582
Hamamatsu University Hospital ( Site 2016)
Hamamatsu, Shizuoka, 431-3192
Kobe University Hospital ( Site 2012)
Kobe, Hyōgo, 650-0017
Kure Kyosai Hospital ( Site 2017)
Kure, Hiroshima, 7378505
Kurume University Hospital ( Site 2014)
Kurume, Fukuoka, 830-0011
Kyorin University Hospital ( Site 2005)
Mitaka, Tokyo, 181-8611
Nagoya University Hospital ( Site 2010)
Nagoya, Aichi-ken, 466-8560
Chiba Saiseikai Narashino hospital ( Site 2004)
Narashino, Chiba, 275-8580
National Hospital Organization Okayama Medical Center ( Site 2013)
Okayama, 701-1192
Sapporo Medical University Hospital ( Site 2018)
Sapporo, Hokkaido, 060-8543
Hokkaido University Hospital ( Site 2001)
Sapporo, Hokkaido, 060-8648
Tohoku University Hospital ( Site 2002)
Sendai, Miyagi, 980-8574
National Cerebral and Cardiovascular Center ( Site 2011)
Suita, Osaka, 564-8565
International University of Health and Welfare Mita Hospital ( Site 2008)
Tokyo, 108-8329
Keio university hospital ( Site 2007)
Tokyo, 1608582

Other trials in Japan

About this study

Official title: A Phase 3 Non-randomized, Non-controlled, Open Label Clinical Study to Evaluate the Efficacy and Safety of MK-7962 (Sotatercept) add-on to Background Therapy in Japanese Participants With Pulmonary Arterial Hypertension (PAH)

Conditions: Pulmonary Arterial Hypertension
Being tested: Sotatercept
Medical subject headings: Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SotaterceptBiological
Also called MK-7962, ActRIIA-IgG1Fc, ACE-011
SC injection at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 21 days plus background PAH therapy.

Study groups in NCT05818137
Study group	Role	What they receive
Sotatercept	Experimental	Participants on background PAH therapy will receive sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks. Thereafter, participants may choose to receive the sotatercept treatment at same dose and schedule in the extension treatment period from Week 24 until up to 6 months after sotatercept becomes locally commercially available and reimbursed in Japan. Receives: Biological: Sotatercept

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Pulmonary Vascular Resistance (PVR) From Baseline at Week 24
PVR was the resistance against blood flow from the pulmonary artery to the left atrium. PVR was measured in dyn*sec/cm^5 by right heart catheterization (RHC). RHC was performed during the screening period (baseline) and Week 24. Per protocol, the change in PVR from baseline at Week 24 was reported for the primary treatment period.
Measured: Baseline and Week 24
Number of Participants Who Experienced an Adverse Event (AE)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who experienced an AE were reported for the primary treatment period.
Measured: Up to ~24 weeks
Number of Participants Who Discontinued Study Intervention Due to AEs
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who discontinued study treatment due to AEs were reported for the primary treatment period.
Measured: Up to ~24 weeks

Secondary outcomes (3)

Change From Baseline in Six-Minute Walk Distance (6MWD) at Week 24
The 6MWD was the distance walked in 6 minutes as a measure of functional capacity was measured during the screening period (baseline) and at Week 24. This was assessed using the 6-minute walk test (6MWT). Per protocol, the change from baseline in 6MWD at Week 24 was reported for the primary treatment period.
Measured: Baseline and Week 24
Percentage of Participants With Improvement in World Health Organization Functional Class (WHO FC) at Week 24
The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. Per protocol, the percentage of participants with improvement in WHO FC at Week 24 were presented for the primary treatment period.
Measured: Baseline and Week 24
Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 24
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP was measured at Day 1 (baseline) and at Week 24. The change from baseline in NT-proBNP at Week 24 was reported for the primary treatment period.
Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 20236 Nov 2025

First posted18 Apr 2023
Study start10 May 2023
Primary completion12 Mar 2024
Study completion6 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05818137
Sponsor's protocol ID: 7962-020
Other IDs: jRCT2031230046, MK-7962-020
Status last verified: Jun 2026
First submitted: 5 Apr 2023
Last updated: 10 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Matsubara H, Tanabe N, Ogo T, Abe K, Inami T, Maeda Y, Arano I, Shirakawa M, Sakai R, Cornell AG; Sotatercept Study 020 Investigators. Phase 3, Open-Label Multicenter Study of Sotatercept in Japanese Participants With Pulmonary Arterial Hypertension. JACC Asia. 2026 Mar;6(3):297-309. doi: 10.1016/j.jacasi.2025.12.009. Epub 2026 Jan 31.
PubMed 41618947

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Non-randomized, Non-controlled, Open Label Clinical Study to Evaluate the Efficacy and Safety of MK-7962 (Sotatercept) add-on to Background Therapy in Japanese Participants With Pulmonary Arterial Hypertension (PAH)
ClinicalTrials.gov ID: NCT05818137
Acronym / sponsor ID: 7962-020
Conditions: Pulmonary Arterial Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 10 May 2023 (actual)
Primary completion: 12 Mar 2024 (actual)
Study completion: 6 Nov 2025 (actual)
First posted: 18 Apr 2023 (actual)
Results: Posted 27 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sotatercept	Experimental	Biological: SotaterceptParticipants on background PAH therapy will receive sotatercept subcutaneous (SC) injections at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks up to 24 weeks. Thereafter, participants may choose to receive the sotatercept treatment at same dose and schedule in the extension treatment period from Week 24 until up to 6 months after sotatercept becomes locally commercially available and reimbursed in Japan.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of World Health Organization (WHO) pulmonary arterial hypertension (PAH) Group 1 in any of the following subtypes:
PAH classified as WHO functional class (FC) I or symptomatic PAH classified as WHO FC II to IV
On stable doses of background PAH therapy and diuretics (if applicable) for at least 90 days prior to screening

Key exclusion criteria (24 listed)

Diagnosis of PH WHO Groups 2, 3, 4, or 5
Diagnosis of the following PAH Group 1 subtypes:
Is on the waiting list for lung transplant
Pregnant or breastfeeding women
History of full or partial pneumonectomy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SotaterceptAlso: MK-7962, ActRIIA-IgG1Fc, ACE-011SC injection at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 21 days plus background PAH therapy.	Biological	Sotatercept

Primary outcome

Change From Pulmonary Vascular Resistance (PVR) From Baseline at Week 24
Time frame: Baseline and Week 24
PVR was the resistance against blood flow from the pulmonary artery to the left atrium. PVR was measured in dyn*sec/cm^5 by right heart catheterization (RHC). RHC was performed during the screening period (baseline) and Week 24. Per protocol, the change in PVR from baseline at Week 24 was reported for the primary treatment period.
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to ~24 weeks
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who experienced an AE were reported for the primary treatment period.
Number of Participants Who Discontinued Study Intervention Due to AEs
Time frame: Up to ~24 weeks
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, the number of participants who discontinued study treatment due to AEs were reported for the primary treatment period.

3 secondary outcomes

Change From Baseline in Six-Minute Walk Distance (6MWD) at Week 24
Time frame: Baseline and Week 24
Percentage of Participants With Improvement in World Health Organization Functional Class (WHO FC) at Week 24
Time frame: Baseline and Week 24
Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 24
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 27 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sotatercept	46	46

Primary outcome: Change From Pulmonary Vascular Resistance (PVR) From Baseline at Week 24

Time frame: Baseline and Week 24. Median (Full Range). Unit: dynes*sec/cm^5

Measure	Sotatercept - Primary Treatment Period n = 46
Value	417.2 (235.2 to 812.8)

Sotatercept - Primary Treatment Period: Change from baseline estimate: -99.2 (95% CI -129.6 to -68.4)

Population analysed: All participants who received at least one dose of study intervention in the primary treatment period.

Primary outcome: Number of Participants Who Experienced an Adverse Event (AE)

Time frame: Up to ~24 weeks. Count of participants. Unit: Participants

Measure	Sotatercept - Primary Treatment Period n = 46
Value	43

Population analysed: All participants who received at least one dose of study intervention in the primary treatment period.

Primary outcome: Number of Participants Who Discontinued Study Intervention Due to AEs

Time frame: Up to ~24 weeks. Count of participants. Unit: Participants

Measure	Sotatercept - Primary Treatment Period n = 46
Value	0

Population analysed: All participants who received at least one dose of study intervention in the primary treatment period.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 42 weeks (Primary treatment period: Weeks 1-24 & extension Treatment Period: Weeks 24-42). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sotatercept - Primary Treatment Period	6 of 46 (13%)	36 of 46 (78.3%)	0 of 46
Sotatercept - Extension Treatment Period	2 of 45 (4.4%)	12 of 45 (26.7%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 41618947Matsubara H, Tanabe N, Ogo T, Abe K, Inami T, Maeda Y, Arano I, Shirakawa M, Sakai R, Cornell AG; Sotatercept Study 020 Investigators. Phase 3, Open-Label Multicenter Study of Sotatercept in Japanese Participants With Pulmonary Arterial Hypertension. JACC Asia. 2026 Mar;6(3):297-309. doi: 10.1016/j.jacasi.2025.12.009. Epub 2026 Jan 31.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotatercept in people with Pulmonary Arterial Hypertension, run by Merck Sharp & Dohme LLC at 17 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Pulmonary Vascular Resistance (PVR) From Baseline at Week 24 (time frame: Baseline and Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05818137, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.