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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Biological: Sotatercept; Drug: Background PAH Therapy

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Corrientes, Argentina, W3400AMZ
    • Instituto de Cardiologia Juana F. Cabral ( Site 0008)
  • Santa Fe, Argentina, S3000EOM
    • Hospital Provincial Jose Maria Cullen ( Site 0005)
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, B1904AAW
      • Centro Medico Capital ( Site 0002)
    • Mar del Plata, Buenos Aires, Argentina, B7600FZO
      • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)
  • Córdoba Province
    • Río Cuarto, Córdoba Province, Argentina, X5800AEV
      • Instituto Medico Rio Cuarto ( Site 0010)
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital ( Site 0103)
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital ( Site 0100)
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Wesley Research Institute ( Site 0101)
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital ( Site 0102)
• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • IUCPQ ( Site 0208)
• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital-Cardiology ( Site 2000)
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University ( Site 2002)
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Shanghai Pulmonary Hospital ( Site 2004)
  • Yunnan
    • Kunming, Yunnan, China, 650051
      • Yan an Hospital of Kunming City ( Site 2011)
• Colombia
  • Bogota D.C.
    • Bogotá, Bogota D.C., Colombia, 110111
      • Clinica Colsanitas - Sede Reina Sofia ( Site 0303)
    • Bogotá, Bogota D.C., Colombia, 110111
      • Fundacion Santa Fe de Bogota ( Site 0302)
  • Departamento de Córdoba
    • Montería, Departamento de Córdoba, Colombia, 230002
      • IMAT S.A.S ( Site 0301)
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia, 760042
      • Clínica Imbanaco S.A.S ( Site 0304)
• Czechia
  • Praha 2
    • Prague, Praha 2, Czechia, 128 08
      • Vseobecna fakultni nemocnice v Praze ( Site 0400)
• France
  • Aquitaine
    • Pessac, Aquitaine, France, 33600
      • CHU Bordeaux Haut-Leveque ( Site 0501)
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13015
      • C.H.U Hôpital Nord ( Site 0500)
  • Haute-Normandie
    • Rouen, Haute-Normandie, France, 76000
      • CHU de Rouen ( Site 0503)
  • Puy-de-Dome
    • Clermont-Ferrand, Puy-de-Dome, France, 63000
      • CHU GABRIEL MONTPIED ( Site 0504)
• Hungary
  • Csongrád megye
    • Szeged, Csongrád megye, Hungary, 6725
      • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Családorvosi Intézet és Rendelő ( Site 0704)
  • Pest County
    • Budapest, Pest County, Hungary, 1083
      • Semmelweis Egyetem ( Site 0701)
    • Budapest, Pest County, Hungary, 1096
      • Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0702)
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus ( Site 0802)
  • Haifa, Israel, 3436212
    • Carmel Hospital ( Site 0803)
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center ( Site 0805)
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center ( Site 0801)
• Italy
  • Bologna, Italy, 40139
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905)
  • Genova, Italy, 16132
    • Ospedale San Martino ( Site 0901)
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo ( Site 0909)
  • Roma, Italy, 00161
    • AOU Policlinico Umberto I ( Site 0910)
  • Sassari, Italy, 07100
    • Ospedale Civile SS Annunziata ( Site 0903)
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0902)
  • Veneto
    • Verona, Veneto, Italy, 37126
      • Azienda Ospedaliera Universitaria Integrata ( Site 0908)
• Japan
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital ( Site 2105)
  • Okayama, Japan, 701-1192
    • National Hospital Organization Okayama Medical Center ( Site 2104)
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 466-8560
      • Nagoya University Hospital ( Site 2102)
  • Osaka
    • Suita, Osaka, Japan, 564-8565
      • National Cerebral and Cardiovascular Center ( Site 2103)
  • Tokyo
    • Bunkyo, Tokyo, Japan, 113-8655
      • The University of Tokyo Hospital ( Site 2101)
    • Mitaka, Tokyo, Japan, 181-8611
      • Kyorin University Hospital ( Site 2100)
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboud University Medical Center ( Site 1001)
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435CM
      • Sint Antonius Ziekenhuis ( Site 1000)
• Singapore
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 119074
      • National University Heart Centre, Singapore ( Site 1200)
    • Singapore, Central Singapore, Singapore, 169609
      • National Heart Centre Singapore ( Site 1201)
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital ( Site 1302)
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System ( Site 1300)
  • Seoul, South Korea, 05505
    • Asan Medical Center ( Site 1303)
  • Seoul, South Korea, 06351
    • Samsung Medical Center ( Site 1301)
  • Kwangju-Kwangyokshi
    • Gwangju, Kwangju-Kwangyokshi, South Korea, 61469
      • Chonnam National University Hospital ( Site 1304)
  • Pusan-Kwangyokshi
    • Seogu, Pusan-Kwangyokshi, South Korea, 49241
      • Pusan National University Hospital ( Site 1305)
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d''Hebron ( Site 1404)
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz ( Site 1410)
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre ( Site 1403)
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio ( Site 1407)
  • Toledo, Spain, 45007
    • HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1408)
  • Balearic Islands
    • Palma, Balearic Islands, Spain, 07120
      • Hospital Universitari Son Espases ( Site 1412)
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla ( Site 1405)
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clinic de Barcelona ( Site 1406)
• Taiwan
  • Tainan, Taiwan, 704302
    • National Cheng Kung University Hospital ( Site 1501)
  • Taipei, Taiwan, 112201
    • Taipei Veterans General Hospital ( Site 1502)
• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital ( Site 1600)
  • Chiang Mai
    • Muang, Chiang Mai, Thailand, 50200
      • Maharaj Nakorn Chiang Mai Hospital ( Site 1601)
• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
      • Royal Papworth Hospital ( Site 1802)
  • England
    • London, England, United Kingdom, NW3 2QG
      • Royal Free Hospital ( Site 1803)
  • London, City of
    • London, London, City of, United Kingdom, W12 OHS
      • Hammersmith Hospital ( Site 1801)
    • London, London, City of, United Kingdom, SW3 6HP
      • Royal Brompton Hospital ( Site 1804)
  • Scotland
    • Glasgow, Scotland, United Kingdom, G81 4DY
      • Golden Jubilee National Hospital ( Site 1800)
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930)
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center ( Site 1928)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Biological: Sotatercept; SC injection administered every 3 weeks; Other Names: ACE-011; MK-7962; Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 28 months
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.	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): June 16, 2028
• Study Completion (Estimated): June 16, 2028

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Pulmonary Arterial Hypertension; ACE-011
• Other Study ID Numbers: 7962-031; MK-7962-031 (Other Identifier: MSD); U1111-1314-0614 (Registry Identifier: UTN); 2024-518687-12-00 (Registry Identifier: EU CT); jRCT2061250021 (Registry Identifier: jRCT (Japan Registry of Clinical Trials))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No