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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

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.

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)

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. There are no hypotheses for this study.

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 groupRoleWhat they receive
SotaterceptExperimentalParticipants 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.

  1. 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

  2. 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

  3. 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)

  1. 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

  2. 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

  3. 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.

  1. First posted18 Apr 2023
  2. Study start10 May 2023
  3. Primary completion12 Mar 2024
  4. Study completion6 Nov 2025

Resources

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
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

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