A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (PAH) (MK-7962-024) (LIGHTRAY)

December 3, 2025 updated by: Merck Sharp & Dohme LLC

A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care

Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs.

The goal of the study is to learn:

  • What happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial.
  • About the safety of sotatercept and if people tolerate it

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • CABA, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires ( Site 0004)
      • Corrientes, Argentina, W3400AMZ
        • Instituto de Cardiologia Juana F. Cabral ( Site 0008)
      • Santa Fe, Argentina, 3000
        • 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
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • Peter Lougheed Centre ( Site 0203)
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • IUCPQ ( Site 0208)
  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People s Hospital ( 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
    • Antioquia
      • Medellín, Antioquia, Colombia, 050034
        • Clinica Cardio VID ( Site 0307)
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110111
        • Clinica Colsanitas - Sede Reina Sofia ( Site 0303)
    • Cundinamarca
      • Bogota, Cundinamarca, 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)
      • Cali, Valle del Cauca Department, Colombia, 760036
        • Centro de Investigaciones Clinicas SAS ( Site 0306)
  • Czechia
    • Praha 2
      • Prague, Praha 2, Czechia, 128 08
        • Centrum pro plicní hypertenzi VFN II. interni klinika VFN a 1. LF UK ( Site 0400)
  • France
    • Aquitaine
      • Pessac, Aquitaine, France, 33604
        • CHU Bordeaux Haut-Leveque ( Site 0501)
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13015
        • Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0500)
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21079
        • CHU Dijon Bourgogne ( Site 0502)
    • Haute-Normandie
      • Rouen, Haute-Normandie, France, 76000
        • CHU de Rouen ( Site 0503)
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, France, 63003
        • CHU GABRIEL MONTPIED ( Site 0504)
  • Germany
      • Berlin, Germany, 10117
        • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0609)
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf ( Site 0610)
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 0600)
    • Bavaria
      • München, Bavaria, Germany, 81377
        • Klinikum der Universität München Großhadern ( Site 0611)
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Medizinische Hochschule Hannover ( Site 0604)
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitätsklinikum Bonn ( Site 0608)
  • Hungary
      • Budapest, Hungary, 1096
        • Gottsegen Gyorgy Orszagos Kardiologiai Intezet ( Site 0702)
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6725
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 0704)
    • Pecs
      • Pécs, Pecs, Hungary, 7624
        • Pécsi Tudományegyetem Klinikai Központ ( Site 0703)
    • Pest County
      • Budapest, Pest County, Hungary, 1083
        • Semmelweis Egyetem ( Site 0701)
  • 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
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0902)
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo ( Site 0909)
      • Pisa, Italy, 56124
        • Fondazione G. Monasterio ( Site 0907)
      • Sassari, Italy, 07100
        • Ospedale Civile SS Annunziata ( Site 0903)
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905)
    • Lazio
      • Rome, Lazio, Italy, 00161
        • AOU Policlinico Umberto I ( Site 0910)
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • Ospedale San Martino ( Site 0901)
    • Lombardy
      • Milan, Lombardy, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda ( Site 0900)
      • Monza, Lombardy, Italy, 20900
        • Fondazione IRCCS San Gerardo dei Tintori ( Site 0911)
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • A.O.U. Citta della Salute e della Scienza di Torino ( Site 0904)
    • 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)
  • Poland
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-202
        • Krakowski Szpital Specjalistyczny im. św. Jana Pawła II ( Site 1100)
  • 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 (CNUH) ( Site 1304)
    • Pusan-Kwangyokshi
      • Busan, Pusan-Kwangyokshi, South Korea, 49241
        • Pusan National University Hospital ( Site 1305)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall D Hebron ( Site 1404)
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal ( Site 1401)
      • Madrid, Spain, 28041
        • Hospital General Universitario 12 de Octubre ( Site 1403)
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz ( Site 1410)
      • Seville, Spain, 41013
        • Hospital Virgen del Rocio ( Site 1407)
      • Toledo, Spain, 45007
        • Hospital Universitario de Toledo ( Site 1408)
    • Balearic Islands
      • Palma, Balearic Islands, Spain, 07120
        • Hospital Universitari Son Espases ( Site 1412)
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Marques de Valdecilla ( Site 1405)
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Hospital Clinic de Barcelona ( Site 1406)
  • Taiwan
      • Kaohsiung City, Taiwan, 813414
        • Kaohsiung Veterans General Hospital ( Site 1503)
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital ( Site 1501)
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital ( Site 1502)
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital ( Site 1601)
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital ( Site 1600)
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
        • Royal Papworth Hospital ( Site 1802)
    • London, City of
      • London, London, City of, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust ( Site 1803)
      • London, London, City of, United Kingdom, SW3 6NP
        • Royal Brompton Hospital ( Site 1804)
      • London, London, City of, United Kingdom, W12 OHS
        • Hammersmith Hospital ( Site 1801)
    • West Dunbartonshire
      • Glasgow, West Dunbartonshire, United Kingdom, G81 4DY
        • Golden Jubilee National Hospital ( Site 1800)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Pulmonary Associates, PA ( Site 1903)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930)
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Methodist Hospital ( Site 1905)
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center ( Site 1928)
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Pulmonary Specialists ( Site 1935)
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center ( Site 1927)
    • Texas
      • Austin, Texas, United States, 78705
        • Ascension Seton Heart Specialty Care and Transplant Center ( Site 1918)
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital & the Medical College of Wisconsin ( Site 1934)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has documented diagnostic Right Heart Catheterization, with the diagnosis of World Health Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
  • Has symptomatic PAH classified as WHO Functional Class II or III

Exclusion Criteria:

  • Has a weight of <35 kg
  • Has a diagnosis of PH WHO Groups 2, 3, 4, or 5
  • Has a diagnosis of the following PAH Group 1 subtypes: HIV-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 should also include schistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis
  • Has uncontrolled systemic hypertension
  • Has a history of pneumonectomy
  • Has a history of known pericardial constriction
  • Has a history of restrictive cardiomyopathy
  • Has history of atrial septostomy (within 180 days prior to study start)
  • Has personal or family history of long QT syndrome
  • Has history of coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start)
  • Has a cerebrovascular accident (within 3 months prior to study start)
  • Has significant (>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
  • Has untreated more than mild obstructive sleep apnea
  • Has known malignancy that is progressing or has required active treatment within the past 5 years
  • Has recently started (within 12 months prior to study start) or has plans to start weight loss medication or enter a weight loss program during the study period
  • Has a previous (within 3 years) or planned (during the study) obesity treatment with surgery or a weight-loss device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weight-based sotatercept dosing
Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of 0.3 mg/kg and then at a maintenance dose of 0.7 mg/kg using a weight-based method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.
Biological: Sotatercept
SC administered every 3 weeks.
Other Names:
  • MK-7962
Biological: 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
Experimental: Weight-banded sotatercept dosing
Participants will receive sotatercept via 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 during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study.
Biological: Sotatercept
SC administered every 3 weeks.
Other Names:
  • MK-7962
Biological: 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
Steady-State Average Serum Concentrations of Sotatercept (Cavg)
Time Frame: Predose and at designated time points post-dose (up to 24 weeks)
Steady-state Cavg of sotatercept will be reported.
Predose and at designated time points post-dose (up to 24 weeks)
Number of Participants Who Experience One or More Adverse Events (AEs)
Time Frame: Up to 37 weeks
An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported.
Up to 37 weeks
Number of Participants who Discontinue Study Treatment due to an Adverse Event
Time Frame: Up to 21 weeks
An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.
Up to 21 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial Dose Average Serum Concentrations of Sotatercept (Cavg)
Time Frame: Predose and at designated time points post-dose (up to 3 weeks)
Initial dose Cavg of sotatercept will be reported.
Predose and at designated time points post-dose (up to 3 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2024

Primary Completion (Actual)

November 20, 2025

Study Completion (Actual)

November 20, 2025

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7962-024
  • U1111-1304-7985 (Registry Identifier: UTN)
  • MK-7962-024 (Other Identifier: MSD)
  • jRCT2061240077 (Registry Identifier: jRCT)
  • 2024-512278-92-00 (Registry Identifier: EU CT)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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