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Pulmonary Arterial HypertensionPhase 2LIGHTRAYNCT06664801

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

A Phase 2 study testing Sotatercept and Background PAH Therapy in people with Pulmonary Arterial Hypertension, run by Merck Sharp & Dohme LLC at 98 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Sotatercept and Background PAH Therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
98 sitesin 21 countries
Study dates
14 Nov 2024to 20 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

98 sites in 21 countries.

98 sites in 21 countries

Italy11 sites

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905)

    Bologna, Emilia-Romagna, 40138

  • Ospedale San Martino ( Site 0901)

    Genoa, Liguria, 16132

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0900)

    Milan, Lombardy, 20162

  • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0902)

    Milan, 20122

  • Fondazione IRCCS San Gerardo dei Tintori ( Site 0911)

    Monza, Lombardy, 20900

  • Fondazione IRCCS Policlinico San Matteo ( Site 0909)

    Pavia, 27100

  • Fondazione G. Monasterio ( Site 0907)

    Pisa, 56124

  • AOU Policlinico Umberto I ( Site 0910)

    Rome, Lazio, 00161

  • Ospedale Civile SS Annunziata ( Site 0903)

    Sassari, 07100

  • A.O.U. Citta della Salute e della Scienza di Torino ( Site 0904)

    Turin, Piedmont, 10126

  • Azienda Ospedaliera Universitaria Integrata ( Site 0908)

    Verona, Veneto, 37126

Other trials in Italy

United States9 sites

  • University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)

    Albuquerque, New Mexico, 87131

  • University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930)

    Aurora, Colorado, 80045

  • Ascension Seton Heart Specialty Care and Transplant Center ( Site 1918)

    Austin, Texas, 78705

  • University of Cincinnati Medical Center ( Site 1927)

    Cincinnati, Ohio, 45219

  • Indiana University Health Methodist Hospital ( Site 1905)

    Indianapolis, Indiana, 46202

  • University of Kansas Medical Center ( Site 1928)

    Kansas City, Kansas, 66160

  • Norton Pulmonary Specialists ( Site 1935)

    Louisville, Kentucky, 40202

  • Froedtert Hospital & the Medical College of Wisconsin ( Site 1934)

    Milwaukee, Wisconsin, 53226

  • Pulmonary Associates, PA ( Site 1903)

    Phoenix, Arizona, 85032

Other trials in United States

Spain9 sites

  • Hospital Clinic de Barcelona ( Site 1406)

    Barcelona, Catalonia, 08036

  • Hospital Vall D Hebron ( Site 1404)

    Barcelona, 08035

  • Hospital Ramon y Cajal ( Site 1401)

    Madrid, 28034

  • Hospital General Universitario 12 de Octubre ( Site 1403)

    Madrid, 28041

  • Hospital Universitario La Paz ( Site 1410)

    Madrid, 28046

  • Hospital Universitari Son Espases ( Site 1412)

    Palma, Balearic Islands, 07120

  • Hospital Marques de Valdecilla ( Site 1405)

    Santander, Cantabria, 39008

  • Hospital Virgen del Rocio ( Site 1407)

    Seville, 41013

  • Hospital Universitario de Toledo ( Site 1408)

    Toledo, 45007

Other trials in Spain

Argentina6 sites

  • Hospital Britanico de Buenos Aires ( Site 0004)

    CABA, C1280AEB

  • Instituto de Cardiologia Juana F. Cabral ( Site 0008)

    Corrientes, W3400AMZ

  • Centro Medico Capital ( Site 0002)

    La Plata, Buenos Aires, B1904AAW

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)

    Mar del Plata, Buenos Aires, B7600FZO

  • Instituto Medico Rio Cuarto ( Site 0010)

    Río Cuarto, Córdoba Province, X5800AEV

  • Hospital Provincial Jose Maria Cullen ( Site 0005)

    Santa Fe, 3000

Other trials in Argentina

Colombia6 sites

  • Fundacion Santa Fe de Bogota ( Site 0302)

    Bogota, Cundinamarca, 110111

  • Clinica Colsanitas - Sede Reina Sofia ( Site 0303)

    Bogotá, Bogota D.C., 110111

  • Centro de Investigaciones Clinicas SAS ( Site 0306)

    Cali, Valle del Cauca Department, 760036

  • Clínica Imbanaco S.A.S ( Site 0304)

    Cali, Valle del Cauca Department, 760042

  • Clinica Cardio VID ( Site 0307)

    Medellín, Antioquia, 050034

  • IMAT S.A.S ( Site 0301)

    Montería, Departamento de Córdoba, 230002

Other trials in Colombia

Germany6 sites

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0609)

    Berlin, 10117

  • Universitätsklinikum Bonn ( Site 0608)

    Bonn, North Rhine-Westphalia, 53127

  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0610)

    Hamburg, 20246

  • Medizinische Hochschule Hannover ( Site 0604)

    Hanover, Lower Saxony, 30625

  • Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 0600)

    Heidelberg, Baden-Wurttemberg, 69126

  • Klinikum der Universität München Großhadern ( Site 0611)

    München, Bavaria, 81377

Other trials in Germany

Japan6 sites

  • The University of Tokyo Hospital ( Site 2101)

    Bunkyo, Tokyo, 113-8655

  • Kyushu University Hospital ( Site 2105)

    Fukuoka, 812-8582

  • Kyorin University Hospital ( Site 2100)

    Mitaka, Tokyo, 181-8611

  • Nagoya University Hospital ( Site 2102)

    Nagoya, Aichi-ken, 466-8560

  • National Hospital Organization Okayama Medical Center ( Site 2104)

    Okayama, 701-1192

  • National Cerebral and Cardiovascular Center ( Site 2103)

    Suita, Osaka, 564-8565

Other trials in Japan

South Korea6 sites

  • Pusan National University Hospital ( Site 1305)

    Busan, Pusan-Kwangyokshi, 49241

  • Chonnam National University Hospital (CNUH) ( Site 1304)

    Gwangju, Kwangju-Kwangyokshi, 61469

  • Seoul National University Hospital ( Site 1302)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 1300)

    Seoul, 03722

  • Asan Medical Center ( Site 1303)

    Seoul, 05505

  • Samsung Medical Center ( Site 1301)

    Seoul, 06351

Other trials in South Korea

France5 sites

  • CHU GABRIEL MONTPIED ( Site 0504)

    Clermont-Ferrand, Puy-de-Dome, 63003

  • CHU Dijon Bourgogne ( Site 0502)

    Dijon, Cote-d Or, 21079

  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0500)

    Marseille, Bouches-du-Rhone, 13015

  • CHU Bordeaux Haut-Leveque ( Site 0501)

    Pessac, Aquitaine, 33604

  • CHU de Rouen ( Site 0503)

    Rouen, Haute-Normandie, 76000

Other trials in France

United Kingdom5 sites

  • Royal Papworth Hospital ( Site 1802)

    Cambridge, Cambridgeshire, CB2 0AY

  • Golden Jubilee National Hospital ( Site 1800)

    Glasgow, West Dunbartonshire, G81 4DY

  • Royal Free London NHS Foundation Trust ( Site 1803)

    London, London, City of, NW3 2QG

  • Royal Brompton Hospital ( Site 1804)

    London, London, City of, SW3 6NP

  • Hammersmith Hospital ( Site 1801)

    London, London, City of, W12 OHS

Other trials in United Kingdom

Australia4 sites

  • Wesley Research Institute ( Site 0101)

    Auchenflower, Queensland, 4066

  • Royal Prince Alfred Hospital ( Site 0103)

    Camperdown, New South Wales, 2050

  • The Alfred Hospital ( Site 0102)

    Melbourne, Victoria, 3004

  • Westmead Hospital ( Site 0100)

    Westmead, New South Wales, 2145

Other trials in Australia

China4 sites

  • The Second Xiangya Hospital of Central South University ( Site 2002)

    Changsha, Hunan, 410011

  • Guangdong Provincial People s Hospital ( Site 2000)

    Guangzhou, Guangdong, 510080

  • Yan an Hospital of Kunming City ( Site 2011)

    Kunming, Yunnan, 650051

  • Shanghai Pulmonary Hospital ( Site 2004)

    Shanghai, Shanghai Municipality, 200433

Other trials in China

Hungary4 sites

  • Semmelweis Egyetem ( Site 0701)

    Budapest, Pest County, 1083

  • Gottsegen Gyorgy Orszagos Kardiologiai Intezet ( Site 0702)

    Budapest, 1096

  • Pécsi Tudományegyetem Klinikai Központ ( Site 0703)

    Pécs, Pecs, 7624

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 0704)

    Szeged, Csongrád megye, 6725

Other trials in Hungary

Israel4 sites

  • Rambam Health Care Campus ( Site 0802)

    Haifa, 3109601

  • Carmel Hospital ( Site 0803)

    Haifa, 3436212

  • Rabin Medical Center ( Site 0805)

    Petah Tikva, 4941492

  • Sheba Medical Center ( Site 0801)

    Ramat Gan, 5265601

Other trials in Israel

Taiwan3 sites

  • Kaohsiung Veterans General Hospital ( Site 1503)

    Kaohsiung City, 813414

  • National Cheng Kung University Hospital ( Site 1501)

    Tainan, 70403

  • Taipei Veterans General Hospital ( Site 1502)

    Taipei, 11217

Other trials in Taiwan

Canada2 sites

  • Peter Lougheed Centre ( Site 0203)

    Calgary, Alberta, T1Y 6J4

  • IUCPQ ( Site 0208)

    Québec, Quebec, G1V 4G5

Other trials in Canada

Netherlands2 sites

  • Sint Antonius Ziekenhuis ( Site 1000)

    Nieuwegein, Utrecht, 3435CM

  • Radboud University Medical Center ( Site 1001)

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

Singapore2 sites

  • National University Heart Centre, Singapore ( Site 1200)

    Singapore, Central Singapore, 119074

  • National Heart Centre Singapore ( Site 1201)

    Singapore, Central Singapore, 169609

Other trials in Singapore

Thailand2 sites

  • Faculty of Medicine Siriraj Hospital ( Site 1600)

    Bangkok, Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital ( Site 1601)

    Chiang Mai, 50200

Other trials in Thailand

Czechia1 site

  • Centrum pro plicní hypertenzi VFN II. interni klinika VFN a 1. LF UK ( Site 0400)

    Prague, Praha 2, 128 08

Other trials in Czechia

Poland1 site

  • Krakowski Szpital Specjalistyczny im. św. Jana Pawła II ( Site 1100)

    Krakow, Lesser Poland Voivodeship, 31-202

Other trials in Poland

About this study

Official title: 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
Being tested
Sotatercept, Background PAH Therapy
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotaterceptBiological

    Also called MK-7962

    SC administered every 3 weeks.

  • Background PAH TherapyBiological

    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 groups in NCT06664801
Study groupRoleWhat they receive
Weight-based sotatercept dosingExperimentalParticipants 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.
Receives: Biological: Sotatercept; Biological: Background PAH Therapy
Weight-banded sotatercept dosingExperimentalParticipants 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.
Receives: Biological: Sotatercept; Biological: Background PAH Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Steady-State Average Serum Concentrations of Sotatercept (Cavg)

    Steady-state Cavg of sotatercept will be reported.

    Measured: Predose and at designated time points post-dose (up to 24 weeks)

  2. Number of Participants Who Experience One or More Adverse Events (AEs)

    An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported.

    Measured: Up to 37 weeks

  3. Number of Participants who Discontinue Study Treatment due to an Adverse Event

    An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.

    Measured: Up to 21 weeks

Secondary outcomes (1)

  1. Initial Dose Average Serum Concentrations of Sotatercept (Cavg)

    Initial dose Cavg of sotatercept will be reported.

    Measured: Predose and at designated time points post-dose (up to 3 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2024
  2. Study start14 Nov 2024
  3. Primary completion20 Nov 2025
  4. Study completion20 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06664801
Sponsor's protocol ID
7962-024
Other IDs
2024-512278-92-00, U1111-1304-7985, MK-7962-024, jRCT2061240077
Acronym
LIGHTRAY
Status last verified
Nov 2025
First submitted
28 Oct 2024
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sotatercept and Background PAH Therapy in people with Pulmonary Arterial Hypertension, run by Merck Sharp & Dohme LLC at 98 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in Italy, United States, Spain, Argentina, Colombia and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steady-State Average Serum Concentrations of Sotatercept (Cavg) (time frame: Predose and at designated time points post-dose (up to 24 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06664801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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