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New hope for japanese PAH patients: experimental drug shows promise in phase 3 trial

NCT ID NCT05818137

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called sotatercept (MK-7962) in 46 Japanese adults with pulmonary arterial hypertension (PAH), a serious lung condition that makes the heart work harder. Participants took the drug alongside their usual treatments. The main goals were to see if it improved blood flow in the lungs and to check for side effects. The study was completed and focused on safety and effectiveness in this specific population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

46 people

The number who actually took part.

Started

May 2023

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria * 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 * 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

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension

Contacts and locations

Locations

  • Chiba Saiseikai Narashino hospital ( Site 2004)

    Narashino, Chiba, 275-8580, Japan

  • Chiba University Hospital ( Site 2003)

    Chiba, 260-8677, Japan

  • Hamamatsu University Hospital ( Site 2016)

    Hamamatsu, Shizuoka, 431-3192, Japan

  • Hokkaido University Hospital ( Site 2001)

    Sapporo, Hokkaido, 060-8648, Japan

  • International University of Health and Welfare Mita Hospital ( Site 2008)

    Tokyo, 108-8329, Japan

  • Keio university hospital ( Site 2007)

    Tokyo, 1608582, Japan

  • Kobe University Hospital ( Site 2012)

    Kobe, Hyōgo, 650-0017, Japan

  • Kure Kyosai Hospital ( Site 2017)

    Kure, Hiroshima, 7378505, Japan

  • Kurume University Hospital ( Site 2014)

    Kurume, Fukuoka, 830-0011, Japan

  • Kyorin University Hospital ( Site 2005)

    Mitaka, Tokyo, 181-8611, Japan

  • Kyushu University Hospital ( Site 2015)

    Fukuoka, 812-8582, Japan

  • Nagoya University Hospital ( Site 2010)

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Cerebral and Cardiovascular Center ( Site 2011)

    Suita, Osaka, 564-8565, Japan

  • National Hospital Organization Okayama Medical Center ( Site 2013)

    Okayama, 701-1192, Japan

  • Sapporo Medical University Hospital ( Site 2018)

    Sapporo, Hokkaido, 060-8543, Japan

  • The University of Tokyo Hospital ( Site 2006)

    Bunkyo-ku, Tokyo, 113-8654, Japan

  • Tohoku University Hospital ( Site 2002)

    Sendai, Miyagi, 980-8574, Japan

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