A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)
NCT ID: NCT06925750
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
130 participants
INTERVENTIONAL
2025-05-12
2028-06-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Weight-banded sotatercept dosing
Participants 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.
Sotatercept
SC injection administered every 3 weeks
Background PAH Therapy
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
Interventions
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Sotatercept
SC injection administered every 3 weeks
Background PAH Therapy
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has not started treatment with commercially available sotatercept
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930)
Aurora, Colorado, United States
University of Kansas Medical Center ( Site 1928)
Kansas City, Kansas, United States
University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)
Albuquerque, New Mexico, United States
Centro Medico Capital ( Site 0002)
La Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)
Mar del Plata, Buenos Aires, Argentina
Instituto Medico Rio Cuarto ( Site 0010)
Río Cuarto, Córdoba Province, Argentina
Instituto de Cardiologia Juana F. Cabral ( Site 0008)
Corrientes, , Argentina
Hospital Provincial Jose Maria Cullen ( Site 0005)
Santa Fe, , Argentina
Royal Prince Alfred Hospital ( Site 0103)
Camperdown, New South Wales, Australia
Westmead Hospital ( Site 0100)
Westmead, New South Wales, Australia
Wesley Research Institute ( Site 0101)
Auchenflower, Queensland, Australia
The Alfred Hospital ( Site 0102)
Melbourne, Victoria, Australia
IUCPQ ( Site 0208)
Québec, Quebec, Canada
Guangdong Provincial People's Hospital-Cardiology ( Site 2000)
Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University ( Site 2002)
Changsha, Hunan, China
Shanghai Pulmonary Hospital ( Site 2004)
Shanghai, Shanghai Municipality, China
Yan an Hospital of Kunming City ( Site 2011)
Kunming, Yunnan, China
Clinica Colsanitas - Sede Reina Sofia ( Site 0303)
Bogotá, Bogota D.C., Colombia
Fundacion Santa Fe de Bogota ( Site 0302)
Bogotá, Bogota D.C., Colombia
IMAT S.A.S ( Site 0301)
Montería, Departamento de Córdoba, Colombia
Clínica Imbanaco S.A.S ( Site 0304)
Cali, Valle del Cauca Department, Colombia
Vseobecna fakultni nemocnice v Praze ( Site 0400)
Prague, Praha 2, Czechia
CHU Bordeaux Haut-Leveque ( Site 0501)
Pessac, Aquitaine, France
C.H.U Hôpital Nord ( Site 0500)
Marseille, Bouches-du-Rhone, France
CHU de Rouen ( Site 0503)
Rouen, Haute-Normandie, France
CHU GABRIEL MONTPIED ( Site 0504)
Clermont-Ferrand, Puy-de-Dome, France
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Családorvosi Intézet és Rendelő ( Site 0704)
Szeged, Csongrád megye, Hungary
Semmelweis Egyetem ( Site 0701)
Budapest, Pest County, Hungary
Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0702)
Budapest, Pest County, Hungary
Rambam Health Care Campus ( Site 0802)
Haifa, , Israel
Carmel Hospital ( Site 0803)
Haifa, , Israel
Rabin Medical Center ( Site 0805)
Petah Tikva, , Israel
Sheba Medical Center ( Site 0801)
Ramat Gan, , Israel
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0902)
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Integrata ( Site 0908)
Verona, Veneto, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905)
Bologna, , Italy
Ospedale San Martino ( Site 0901)
Genova, , Italy
Fondazione IRCCS Policlinico San Matteo ( Site 0909)
Pavia, , Italy
AOU Policlinico Umberto I ( Site 0910)
Roma, , Italy
Ospedale Civile SS Annunziata ( Site 0903)
Sassari, , Italy
Nagoya University Hospital ( Site 2102)
Nagoya, Aichi-ken, Japan
National Cerebral and Cardiovascular Center ( Site 2103)
Suita, Osaka, Japan
The University of Tokyo Hospital ( Site 2101)
Bunkyo, Tokyo, Japan
Kyorin University Hospital ( Site 2100)
Mitaka, Tokyo, Japan
Kyushu University Hospital ( Site 2105)
Fukuoka, , Japan
National Hospital Organization Okayama Medical Center ( Site 2104)
Okayama, , Japan
Radboud University Medical Center ( Site 1001)
Nijmegen, Gelderland, Netherlands
Sint Antonius Ziekenhuis ( Site 1000)
Nieuwegein, Utrecht, Netherlands
National University Heart Centre, Singapore ( Site 1200)
Singapore, Central Singapore, Singapore
National Heart Centre Singapore ( Site 1201)
Singapore, Central Singapore, Singapore
Chonnam National University Hospital ( Site 1304)
Gwangju, Kwangju-Kwangyokshi, South Korea
Pusan National University Hospital ( Site 1305)
Seogu, Pusan-Kwangyokshi, South Korea
Seoul National University Hospital ( Site 1302)
Seoul, , South Korea
Severance Hospital Yonsei University Health System ( Site 1300)
Seoul, , South Korea
Asan Medical Center ( Site 1303)
Seoul, , South Korea
Samsung Medical Center ( Site 1301)
Seoul, , South Korea
Hospital Universitari Son Espases ( Site 1412)
Palma, Balearic Islands, Spain
Hospital Universitario Marqués de Valdecilla ( Site 1405)
Santander, Cantabria, Spain
Hospital Clinic de Barcelona ( Site 1406)
Barcelona, Catalonia, Spain
Hospital Universitari Vall d''Hebron ( Site 1404)
Barcelona, , Spain
Hospital Universitario 12 de Octubre ( Site 1403)
Madrid, , Spain
Hospital Universitario La Paz ( Site 1410)
Madrid, , Spain
Hospital Universitario Virgen del Rocio ( Site 1407)
Seville, , Spain
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1408)
Toledo, , Spain
National Cheng Kung University Hospital ( Site 1501)
Tainan, , Taiwan
Taipei Veterans General Hospital ( Site 1502)
Taipei, , Taiwan
Faculty of Medicine Siriraj Hospital ( Site 1600)
Bangkoknoi, Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 1601)
Muang, Chiang Mai, Thailand
Royal Papworth Hospital ( Site 1802)
Cambridge, Cambridgeshire, United Kingdom
Royal Free Hospital ( Site 1803)
London, England, United Kingdom
Royal Brompton Hospital ( Site 1804)
London, London, City of, United Kingdom
Hammersmith Hospital ( Site 1801)
London, London, City of, United Kingdom
Golden Jubilee National Hospital ( Site 1800)
Glasgow, Scotland, United Kingdom
Countries
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-7962-031
Identifier Type: OTHER
Identifier Source: secondary_id
2024-518687-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1314-0614
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2061250021
Identifier Type: REGISTRY
Identifier Source: secondary_id
7962-031
Identifier Type: -
Identifier Source: org_study_id
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