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New hope for PAH patients: sotatercept safety trial expands

NCT ID NCT06925750

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

What the study statuses mean

This study's is highlighted.

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at the long-term safety of a medicine called sotatercept for people with pulmonary arterial hypertension (PAH). Participants from an earlier study can join and receive weight-based doses every 3 weeks. The main goal is to see if the medicine is safe and well-tolerated over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sotatercept
What this could lead to
If successful, this could confirm that weight-banded dosing of sotatercept is safe and tolerable for long-term use in PAH patients.
What could go wrong
This is a small, early-phase extension study focused on safety, not effectiveness. It may not show clear benefits, and side effects are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

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: The main inclusion criteria include but are not limited to the following: * Has completed the treatment period of study MK-7962-024 (LIGHTRAY) (including Visit 11) on study intervention, did not discontinue study intervention, and is able to safely enroll into MK-7962-031 (LIGHTRAY EXTENSION) * Has not started treatment with commercially available sotatercept Exclusion Criteria: The main exclusion criteria include but are not limited to the following: \- Has current exposure or is planning to begin treatment with an activin signaling inhibitor (other than sotatercept)

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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

  • AOU Policlinico Umberto I ( Site 0910)

    Roma, 00161, Italy

  • Asan Medical Center ( Site 1303)

    Seoul, 05505, South Korea

  • Azienda Ospedaliera Universitaria Integrata ( Site 0908)

    Verona, Veneto, 37126, Italy

  • C.H.U Hôpital Nord ( Site 0500)

    Marseille, Bouches-du-Rhone, 13015, France

  • CHU Bordeaux Haut-Leveque ( Site 0501)

    Pessac, Aquitaine, 33600, France

  • CHU GABRIEL MONTPIED ( Site 0504)

    Clermont-Ferrand, Puy-de-Dome, 63000, France

  • CHU de Rouen ( Site 0503)

    Rouen, Haute-Normandie, 76000, France

  • Carmel Hospital ( Site 0803)

    Haifa, 3436212, Israel

  • Centro Medico Capital ( Site 0002)

    La Plata, Buenos Aires, B1904AAW, Argentina

  • Chonnam National University Hospital ( Site 1304)

    Gwangju, Kwangju-Kwangyokshi, 61469, South Korea

  • Clinica Colsanitas - Sede Reina Sofia ( Site 0303)

    Bogotá, Bogota D.C., 110111, Colombia

  • Clínica Imbanaco S.A.S ( Site 0304)

    Cali, Valle del Cauca Department, 760042, Colombia

  • Faculty of Medicine Siriraj Hospital ( Site 1600)

    Bangkoknoi, Bangkok, 10700, Thailand

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0902)

    Milan, Lombardy, 20122, Italy

  • Fondazione IRCCS Policlinico San Matteo ( Site 0909)

    Pavia, 27100, Italy

  • Fundacion Santa Fe de Bogota ( Site 0302)

    Bogotá, Bogota D.C., 110111, Colombia

  • Golden Jubilee National Hospital ( Site 1800)

    Glasgow, Scotland, G81 4DY, United Kingdom

  • Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0702)

    Budapest, Pest County, 1096, Hungary

  • Guangdong Provincial People's Hospital-Cardiology ( Site 2000)

    Guangzhou, Guangdong, 510080, China

  • HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1408)

    Toledo, 45007, Spain

  • Hammersmith Hospital ( Site 1801)

    London, London, City of, W12 OHS, United Kingdom

  • Hospital Clinic de Barcelona ( Site 1406)

    Barcelona, Catalonia, 08036, Spain

  • Hospital Provincial Jose Maria Cullen ( Site 0005)

    Santa Fe, S3000EOM, Argentina

  • Hospital Universitari Son Espases ( Site 1412)

    Palma, Balearic Islands, 07120, Spain

  • Hospital Universitari Vall d''Hebron ( Site 1404)

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre ( Site 1403)

    Madrid, 28041, Spain

  • Hospital Universitario La Paz ( Site 1410)

    Madrid, 28046, Spain

  • Hospital Universitario Marqués de Valdecilla ( Site 1405)

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Virgen del Rocio ( Site 1407)

    Seville, 41013, Spain

  • IMAT S.A.S ( Site 0301)

    Montería, Departamento de Córdoba, 230002, Colombia

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905)

    Bologna, 40139, Italy

  • IUCPQ ( Site 0208)

    Québec, Quebec, G1V 4G5, Canada

  • Instituto Medico Rio Cuarto ( Site 0010)

    Río Cuarto, Córdoba Province, X5800AEV, Argentina

  • Instituto de Cardiologia Juana F. Cabral ( Site 0008)

    Corrientes, W3400AMZ, Argentina

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Kyorin University Hospital ( Site 2100)

    Mitaka, Tokyo, 181-8611, Japan

  • Kyushu University Hospital ( Site 2105)

    Fukuoka, 812-8582, Japan

  • Maharaj Nakorn Chiang Mai Hospital ( Site 1601)

    Muang, Chiang Mai, 50200, Thailand

  • Nagoya University Hospital ( Site 2102)

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Cerebral and Cardiovascular Center ( Site 2103)

    Suita, Osaka, 564-8565, Japan

  • National Cheng Kung University Hospital ( Site 1501)

    Tainan, 704302, Taiwan

  • National Heart Centre Singapore ( Site 1201)

    Singapore, Central Singapore, 169609, Singapore

  • National Hospital Organization Okayama Medical Center ( Site 2104)

    Okayama, 701-1192, Japan

  • National University Heart Centre, Singapore ( Site 1200)

    Singapore, Central Singapore, 119074, Singapore

  • Ospedale Civile SS Annunziata ( Site 0903)

    Sassari, 07100, Italy

  • Ospedale San Martino ( Site 0901)

    Genova, 16132, Italy

  • Pusan National University Hospital ( Site 1305)

    Seogu, Pusan-Kwangyokshi, 49241, South Korea

  • Rabin Medical Center ( Site 0805)

    Petah Tikva, 4941492, Israel

  • Radboud University Medical Center ( Site 1001)

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Rambam Health Care Campus ( Site 0802)

    Haifa, 3109601, Israel

  • Royal Brompton Hospital ( Site 1804)

    London, London, City of, SW3 6HP, United Kingdom

  • Royal Free Hospital ( Site 1803)

    London, England, NW3 2QG, United Kingdom

  • Royal Papworth Hospital ( Site 1802)

    Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

  • Royal Prince Alfred Hospital ( Site 0103)

    Camperdown, New South Wales, 2050, Australia

  • Samsung Medical Center ( Site 1301)

    Seoul, 06351, South Korea

  • Semmelweis Egyetem ( Site 0701)

    Budapest, Pest County, 1083, Hungary

  • Seoul National University Hospital ( Site 1302)

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System ( Site 1300)

    Seoul, 03722, South Korea

  • Shanghai Pulmonary Hospital ( Site 2004)

    Shanghai, Shanghai Municipality, 200433, China

  • Sheba Medical Center ( Site 0801)

    Ramat Gan, 5265601, Israel

  • Sint Antonius Ziekenhuis ( Site 1000)

    Nieuwegein, Utrecht, 3435CM, Netherlands

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Családorvosi Intézet és Rendelő ( Site 0704)

    Szeged, Csongrád megye, 6725, Hungary

  • Taipei Veterans General Hospital ( Site 1502)

    Taipei, 112201, Taiwan

  • The Alfred Hospital ( Site 0102)

    Melbourne, Victoria, 3004, Australia

  • The Second Xiangya Hospital of Central South University ( Site 2002)

    Changsha, Hunan, 410011, China

  • The University of Tokyo Hospital ( Site 2101)

    Bunkyo, Tokyo, 113-8655, Japan

  • University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930)

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center ( Site 1928)

    Kansas City, Kansas, 66160, United States

  • University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)

    Albuquerque, New Mexico, 87131, United States

  • Vseobecna fakultni nemocnice v Praze ( Site 0400)

    Prague, Praha 2, 128 08, Czechia

  • Wesley Research Institute ( Site 0101)

    Auchenflower, Queensland, 4066, Australia

  • Westmead Hospital ( Site 0100)

    Westmead, New South Wales, 2145, Australia

  • Yan an Hospital of Kunming City ( Site 2011)

    Kunming, Yunnan, 650051, China

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Other studies related to the condition(s) this trial covers.