A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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
Primary outcome measure(s)
- Number of Participants Who Experience One or More Adverse Events (AEs) — Up to approximately 28 months
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. - Number of Participants who Discontinue Study Intervention Due to an AE — Up to approximately 24 months
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.
Trial sites (73)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930) | Aurora | Colorado | |
| University of Kansas Medical Center ( Site 1928) | Kansas City | Kansas | |
| University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916) | Albuquerque | New Mexico | |
| Centro Medico Capital ( Site 0002) | La Plata | Buenos Aires | |
| Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006) | Mar del Plata | Buenos Aires | |
| Instituto Medico Rio Cuarto ( Site 0010) | Río Cuarto | Córdoba Province | |
| 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 | |
| Westmead Hospital ( Site 0100) | Westmead | New South Wales | |
| Wesley Research Institute ( Site 0101) | Auchenflower | Queensland | |
| The Alfred Hospital ( Site 0102) | Melbourne | Victoria | |
| IUCPQ ( Site 0208) | Québec | Quebec | |
| Guangdong Provincial People's Hospital-Cardiology ( Site 2000) | Guangzhou | Guangdong | |
| The Second Xiangya Hospital of Central South University ( Site 2002) | Changsha | Hunan | |
| Shanghai Pulmonary Hospital ( Site 2004) | Shanghai | Shanghai Municipality | |
| Yan an Hospital of Kunming City ( Site 2011) | Kunming | Yunnan | |
| Clinica Colsanitas - Sede Reina Sofia ( Site 0303) | Bogotá | Bogota D.C. | |
| Fundacion Santa Fe de Bogota ( Site 0302) | Bogotá | Bogota D.C. | |
| IMAT S.A.S ( Site 0301) | Montería | Departamento de Córdoba | |
| Clínica Imbanaco S.A.S ( Site 0304) | Cali | Valle del Cauca Department | |
| Vseobecna fakultni nemocnice v Praze ( Site 0400) | Prague | Praha 2 | |
| CHU Bordeaux Haut-Leveque ( Site 0501) | Pessac | Aquitaine | |
| C.H.U Hôpital Nord ( Site 0500) | Marseille | Bouches-du-Rhone | |
| CHU de Rouen ( Site 0503) | Rouen | Haute-Normandie | |
| CHU GABRIEL MONTPIED ( Site 0504) | Clermont-Ferrand | Puy-de-Dome | |
| Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Családorvosi Intézet és Rendelő ( Site 0704) | Szeged | Csongrád megye | |
| Semmelweis Egyetem ( Site 0701) | Budapest | Pest County | |
| Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0702) | Budapest | Pest County | |
| 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 | |
| Azienda Ospedaliera Universitaria Integrata ( Site 0908) | Verona | Veneto | |
| 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 |
+ 33 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06925750 on ClinicalTrials.gov ↗ ← All trials in France