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Pulmonary Arterial HypertensionPhase 2LIGHTRAY EXTNCT06925750

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)

A Phase 2 study testing Sotatercept and Background PAH Therapy in people with Pulmonary Arterial Hypertension, run by Merck Sharp & Dohme LLC at 73 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Researchers are looking for other ways to treat pulmonary arterial hypertension (PAH). Sotatercept is a study medicine that is designed to treat PAH. A past study, MK-7962-024 (LIGHTRAY) (NCT06664801), learned about the safety and effects of sotatercept in people with PAH. 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 and Background PAH Therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
73 sitesin 19 countries
Study dates
12 May 2025to 16 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • 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

Who cannot join

  • 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)

Trial locations and contacts

73 sites in 19 countries.

73 sites in 19 countries

Spain8 sites

  • Hospital Clinic de Barcelona ( Site 1406)

    Barcelona, Catalonia, 08036

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

    Barcelona, 08035

  • Hospital Universitario 12 de Octubre ( Site 1403)

    Madrid, 28041

  • Hospital Universitario La Paz ( Site 1410)

    Madrid, 28046

  • Hospital Universitari Son Espases ( Site 1412)

    Palma, Balearic Islands, 07120

  • Hospital Universitario Marqués de Valdecilla ( Site 1405)

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio ( Site 1407)

    Seville, 41013

  • HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1408)

    Toledo, 45007

Other trials in Spain

Italy7 sites

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

    Bologna, 40139

  • Ospedale San Martino ( Site 0901)

    Genova, 16132

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

    Milan, Lombardy, 20122

  • Fondazione IRCCS Policlinico San Matteo ( Site 0909)

    Pavia, 27100

  • AOU Policlinico Umberto I ( Site 0910)

    Roma, 00161

  • Ospedale Civile SS Annunziata ( Site 0903)

    Sassari, 07100

  • Azienda Ospedaliera Universitaria Integrata ( Site 0908)

    Verona, Veneto, 37126

Other trials in Italy

Japan6 sites

  • The University of Tokyo Hospital ( Site 2101)

    Bunkyo, Tokyo, 113-8655

  • Kyushu University Hospital ( Site 2105)

    Fukuoka, 812-8582

  • Kyorin University Hospital ( Site 2100)

    Mitaka, Tokyo, 181-8611

  • Nagoya University Hospital ( Site 2102)

    Nagoya, Aichi-ken, 466-8560

  • National Hospital Organization Okayama Medical Center ( Site 2104)

    Okayama, 701-1192

  • National Cerebral and Cardiovascular Center ( Site 2103)

    Suita, Osaka, 564-8565

Other trials in Japan

South Korea6 sites

  • Chonnam National University Hospital ( Site 1304)

    Gwangju, Kwangju-Kwangyokshi, 61469

  • Pusan National University Hospital ( Site 1305)

    Seogu, Pusan-Kwangyokshi, 49241

  • Seoul National University Hospital ( Site 1302)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 1300)

    Seoul, 03722

  • Asan Medical Center ( Site 1303)

    Seoul, 05505

  • Samsung Medical Center ( Site 1301)

    Seoul, 06351

Other trials in South Korea

Argentina5 sites

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

    Corrientes, W3400AMZ

  • Centro Medico Capital ( Site 0002)

    La Plata, Buenos Aires, B1904AAW

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

    Mar del Plata, Buenos Aires, B7600FZO

  • Instituto Medico Rio Cuarto ( Site 0010)

    Río Cuarto, Córdoba Province, X5800AEV

  • Hospital Provincial Jose Maria Cullen ( Site 0005)

    Santa Fe, S3000EOM

Other trials in Argentina

United Kingdom5 sites

  • Royal Papworth Hospital ( Site 1802)

    Cambridge, Cambridgeshire, CB2 0AY

  • Golden Jubilee National Hospital ( Site 1800)

    Glasgow, Scotland, G81 4DY

  • Royal Free Hospital ( Site 1803)

    London, England, NW3 2QG

  • Royal Brompton Hospital ( Site 1804)

    London, London, City of, SW3 6HP

  • Hammersmith Hospital ( Site 1801)

    London, London, City of, W12 OHS

Other trials in United Kingdom

Australia4 sites

  • Wesley Research Institute ( Site 0101)

    Auchenflower, Queensland, 4066

  • Royal Prince Alfred Hospital ( Site 0103)

    Camperdown, New South Wales, 2050

  • The Alfred Hospital ( Site 0102)

    Melbourne, Victoria, 3004

  • Westmead Hospital ( Site 0100)

    Westmead, New South Wales, 2145

Other trials in Australia

China4 sites

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

    Changsha, Hunan, 410011

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

    Guangzhou, Guangdong, 510080

  • Yan an Hospital of Kunming City ( Site 2011)

    Kunming, Yunnan, 650051

  • Shanghai Pulmonary Hospital ( Site 2004)

    Shanghai, Shanghai Municipality, 200433

Other trials in China

Colombia4 sites

  • Clinica Colsanitas - Sede Reina Sofia ( Site 0303)

    Bogotá, Bogota D.C., 110111

  • Fundacion Santa Fe de Bogota ( Site 0302)

    Bogotá, Bogota D.C., 110111

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

    Cali, Valle del Cauca Department, 760042

  • IMAT S.A.S ( Site 0301)

    Montería, Departamento de Córdoba, 230002

Other trials in Colombia

France4 sites

  • CHU GABRIEL MONTPIED ( Site 0504)

    Clermont-Ferrand, Puy-de-Dome, 63000

  • C.H.U Hôpital Nord ( Site 0500)

    Marseille, Bouches-du-Rhone, 13015

  • CHU Bordeaux Haut-Leveque ( Site 0501)

    Pessac, Aquitaine, 33600

  • CHU de Rouen ( Site 0503)

    Rouen, Haute-Normandie, 76000

Other trials in France

Israel4 sites

  • Rambam Health Care Campus ( Site 0802)

    Haifa, 3109601

  • Carmel Hospital ( Site 0803)

    Haifa, 3436212

  • Rabin Medical Center ( Site 0805)

    Petah Tikva, 4941492

  • Sheba Medical Center ( Site 0801)

    Ramat Gan, 5265601

Other trials in Israel

United States3 sites

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

    Albuquerque, New Mexico, 87131

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

    Aurora, Colorado, 80045

  • University of Kansas Medical Center ( Site 1928)

    Kansas City, Kansas, 66160

Other trials in United States

Hungary3 sites

  • Semmelweis Egyetem ( Site 0701)

    Budapest, Pest County, 1083

  • Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0702)

    Budapest, Pest County, 1096

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

    Szeged, Csongrád megye, 6725

Other trials in Hungary

Netherlands2 sites

  • Sint Antonius Ziekenhuis ( Site 1000)

    Nieuwegein, Utrecht, 3435CM

  • Radboud University Medical Center ( Site 1001)

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

Singapore2 sites

  • National University Heart Centre, Singapore ( Site 1200)

    Singapore, Central Singapore, 119074

  • National Heart Centre Singapore ( Site 1201)

    Singapore, Central Singapore, 169609

Other trials in Singapore

Taiwan2 sites

  • National Cheng Kung University Hospital ( Site 1501)

    Tainan, 704302

  • Taipei Veterans General Hospital ( Site 1502)

    Taipei, 112201

Other trials in Taiwan

Thailand2 sites

  • Faculty of Medicine Siriraj Hospital ( Site 1600)

    Bangkoknoi, Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital ( Site 1601)

    Muang, Chiang Mai, 50200

Other trials in Thailand

Canada1 site

  • IUCPQ ( Site 0208)

    Québec, Quebec, G1V 4G5

Other trials in Canada

Czechia1 site

  • Vseobecna fakultni nemocnice v Praze ( Site 0400)

    Prague, Praha 2, 128 08

Other trials in Czechia

About this study

Official title: An Open-label Extension Study to Evaluate Safety and Tolerability of Sotatercept (MK-7962) Administered Using a Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care

Researchers are looking for other ways to treat pulmonary arterial hypertension (PAH). Sotatercept is a study medicine that is designed to treat PAH.

A past study, MK-7962-024 (LIGHTRAY) (NCT06664801), learned about the safety and effects of sotatercept in people with PAH. One of the goals of that study was to learn about sotatercept when given at a dose (amount) based on the weight range a person is in (weight-banded doses) compared to when given based on a person's exact weight.

This is an extension study, which means people who took part in MK-7962-024 (LIGHTRAY) may be able to join this study. In this extension study, people will get weight-banded doses of sotatercept. The main goal of this study is to learn about the safety of weight-banded doses of sotatercept and if people tolerate it over a longer period of time.

Being tested
Sotatercept, Background PAH Therapy
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, ACE-011

    SC injection administered every 3 weeks

  • Background PAH TherapyDrug

    Background PAH therapy may consist of the following drug classes: single, double, or triple combination of therapy with endothelin-receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogs or receptor antagonists

Study groups in NCT06925750
Study groupRoleWhat they receive
Weight-banded sotatercept dosingExperimentalParticipants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of up to 45 mg and then at a maintenance dose of up to 90 mg using a weight-banded method and will continue treatment for up to 24 months. All eligible participants will receive weight-banded dosing at the dosing level (initial or maintenance) at which they finished MK-7962-024 (LIGHTRAY). Participants will continue to take their background PAH therapy during the study.
Receives: Biological: Sotatercept; Drug: Background PAH Therapy

What is being measured

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

  1. Number of Participants Who Experience One or More Adverse Events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

    Measured: Up to approximately 28 months

  2. Number of Participants who Discontinue Study Intervention Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted13 Apr 2025
  2. Study start12 May 2025
  3. Primary completion16 Jun 2028 (estimated)
  4. Study completion16 Jun 2028 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06925750
Sponsor's protocol ID
7962-031
Other IDs
MK-7962-031, 2024-518687-12-00, U1111-1314-0614, jRCT2061250021
Acronym
LIGHTRAY EXT
Status last verified
Dec 2025
First submitted
7 Apr 2025
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sotatercept and Background PAH Therapy in people with Pulmonary Arterial Hypertension, run by Merck Sharp & Dohme LLC at 73 sites in 19 countries.

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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in Spain, Italy, Japan, South Korea, Argentina and 14 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Number of Participants Who Experience One or More Adverse Events (AEs) (time frame: Up to approximately 28 months). The study lists 2 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 NCT06925750.

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 5 Dec 2025.

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