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
Status: Recruiting
Location: See all (72) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
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. 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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
Locations
United States
Colorado
University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930)
RECRUITING
Aurora
Kansas
University of Kansas Medical Center ( Site 1928)
RECRUITING
Kansas City
New Mexico
University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)
ACTIVE_NOT_RECRUITING
Albuquerque
Other Locations
Argentina
Instituto de Cardiologia Juana F. Cabral ( Site 0008)
ACTIVE_NOT_RECRUITING
Corrientes
Centro Medico Capital ( Site 0002)
ACTIVE_NOT_RECRUITING
La Plata
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)
ACTIVE_NOT_RECRUITING
Mar Del Plata
Instituto Medico Rio Cuarto ( Site 0010)
ACTIVE_NOT_RECRUITING
Río Cuarto
Hospital Provincial Jose Maria Cullen ( Site 0005)
ACTIVE_NOT_RECRUITING
Santa Fe
Australia
Wesley Research Institute ( Site 0101)
RECRUITING
Auchenflower
Royal Prince Alfred Hospital ( Site 0103)
RECRUITING
Camperdown
The Alfred Hospital ( Site 0102)
RECRUITING
Melbourne
Westmead Hospital ( Site 0100)
RECRUITING
Westmead
Canada
IUCPQ ( Site 0208)
RECRUITING
Québec
China
The Second Xiangya Hospital of Central South University ( Site 2002)
ACTIVE_NOT_RECRUITING
Changsha
Guangdong Provincial People's Hospital-Cardiology ( Site 2000)
ACTIVE_NOT_RECRUITING
Guangzhou
Yan an Hospital of Kunming City ( Site 2011)
RECRUITING
Kunming
Shanghai Pulmonary Hospital ( Site 2004)
RECRUITING
Shanghai
Colombia
Clinica Colsanitas - Sede Reina Sofia ( Site 0303)
RECRUITING
Bogotá
Fundacion Santa Fe de Bogota ( Site 0302)
RECRUITING
Bogotá
IMAT S.A.S ( Site 0301)
RECRUITING
Montería
Clínica Imbanaco S.A.S ( Site 0304)
RECRUITING
Santiago De Cali
France
CHU GABRIEL MONTPIED ( Site 0504)
ACTIVE_NOT_RECRUITING
Clermont-ferrand
C.H.U Hôpital Nord ( Site 0500)
RECRUITING
Marseille
CHU Bordeaux Haut-Leveque ( Site 0501)
RECRUITING
Pessac
CHU de Rouen ( Site 0503)
ACTIVE_NOT_RECRUITING
Rouen
Hungary
Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0702)
ACTIVE_NOT_RECRUITING
Budapest
Semmelweis Egyetem ( Site 0701)
RECRUITING
Budapest
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Családorvosi Intézet és Rendelő ( Site 0704)
RECRUITING
Szeged
Israel
Carmel Hospital ( Site 0803)
RECRUITING
Haifa
Rambam Health Care Campus ( Site 0802)
ACTIVE_NOT_RECRUITING
Haifa
Rabin Medical Center ( Site 0805)
ACTIVE_NOT_RECRUITING
Petah Tikva
Sheba Medical Center ( Site 0801)
ACTIVE_NOT_RECRUITING
Ramat Gan
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905)
RECRUITING
Bologna
Ospedale San Martino ( Site 0901)
RECRUITING
Genova
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0902)
RECRUITING
Milan
Fondazione IRCCS Policlinico San Matteo ( Site 0909)
RECRUITING
Pavia
AOU Policlinico Umberto I ( Site 0910)
RECRUITING
Roma
Ospedale Civile SS Annunziata ( Site 0903)
RECRUITING
Sassari
Azienda Ospedaliera Universitaria Integrata ( Site 0908)
RECRUITING
Verona
Japan
The University of Tokyo Hospital ( Site 2101)
RECRUITING
Bunkyo
Kyushu University Hospital ( Site 2105)
ACTIVE_NOT_RECRUITING
Fukuoka
Kyorin University Hospital ( Site 2100)
RECRUITING
Mitaka
Nagoya University Hospital ( Site 2102)
ACTIVE_NOT_RECRUITING
Nagoya
National Hospital Organization Okayama Medical Center ( Site 2104)
ACTIVE_NOT_RECRUITING
Okayama
National Cerebral and Cardiovascular Center ( Site 2103)
ACTIVE_NOT_RECRUITING
Suita
Netherlands
Sint Antonius Ziekenhuis ( Site 1000)
RECRUITING
Nieuwegein
Radboud University Medical Center ( Site 1001)
RECRUITING
Nijmegen
Republic of Korea
Chonnam National University Hospital ( Site 1304)
RECRUITING
Gwangju
Pusan National University Hospital ( Site 1305)
RECRUITING
Seogu
Asan Medical Center ( Site 1303)
RECRUITING
Seoul
Samsung Medical Center ( Site 1301)
RECRUITING
Seoul
Seoul National University Hospital ( Site 1302)
RECRUITING
Seoul
Severance Hospital Yonsei University Health System ( Site 1300)
RECRUITING
Seoul
Singapore
National Heart Centre Singapore ( Site 1201)
RECRUITING
Singapore
National University Heart Centre, Singapore ( Site 1200)
RECRUITING
Singapore
Spain
Hospital Clinic de Barcelona ( Site 1406)
RECRUITING
Barcelona
Hospital Universitari Vall d''Hebron ( Site 1404)
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre ( Site 1403)
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario La Paz ( Site 1410)
RECRUITING
Madrid
Hospital Universitari Son Espases ( Site 1412)
RECRUITING
Palma
Hospital Universitario Marqués de Valdecilla ( Site 1405)
RECRUITING
Santander
Hospital Universitario Virgen del Rocio ( Site 1407)
RECRUITING
Seville
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1408)
ACTIVE_NOT_RECRUITING
Toledo
Taiwan
National Cheng Kung University Hospital ( Site 1501)
RECRUITING
Tainan City
Taipei Veterans General Hospital ( Site 1502)
RECRUITING
Taipei
Thailand
Faculty of Medicine Siriraj Hospital ( Site 1600)
RECRUITING
Bangkoknoi
Maharaj Nakorn Chiang Mai Hospital ( Site 1601)
ACTIVE_NOT_RECRUITING
Muang
United Kingdom
Royal Papworth Hospital ( Site 1802)
ACTIVE_NOT_RECRUITING
Cambridge
Golden Jubilee National Hospital ( Site 1800)
ACTIVE_NOT_RECRUITING
Glasgow
Hammersmith Hospital ( Site 1801)
ACTIVE_NOT_RECRUITING
London
Royal Brompton Hospital ( Site 1804)
ACTIVE_NOT_RECRUITING
London
Royal Free Hospital ( Site 1803)
RECRUITING
London
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-05-12
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 130
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC