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

NCT ID: NCT06925750

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2028-06-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Arterial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Sotatercept

Intervention Type BIOLOGICAL

SC injection administered every 3 weeks

Background PAH Therapy

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sotatercept

SC injection administered every 3 weeks

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MK-7962 ACE-011

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

\- Has current exposure or is planning to begin treatment with an activin signaling inhibitor (other than sotatercept)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Aurora, Colorado, United States

Site Status

University of Kansas Medical Center ( Site 1928)

Kansas City, Kansas, United States

Site Status

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

Albuquerque, New Mexico, United States

Site Status

Centro Medico Capital ( Site 0002)

La Plata, Buenos Aires, Argentina

Site Status

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)

Mar del Plata, Buenos Aires, Argentina

Site Status

Instituto Medico Rio Cuarto ( Site 0010)

Río Cuarto, Córdoba Province, Argentina

Site Status

Instituto de Cardiologia Juana F. Cabral ( Site 0008)

Corrientes, , Argentina

Site Status

Hospital Provincial Jose Maria Cullen ( Site 0005)

Santa Fe, , Argentina

Site Status

Royal Prince Alfred Hospital ( Site 0103)

Camperdown, New South Wales, Australia

Site Status

Westmead Hospital ( Site 0100)

Westmead, New South Wales, Australia

Site Status

Wesley Research Institute ( Site 0101)

Auchenflower, Queensland, Australia

Site Status

The Alfred Hospital ( Site 0102)

Melbourne, Victoria, Australia

Site Status

IUCPQ ( Site 0208)

Québec, Quebec, Canada

Site Status

Guangdong Provincial People's Hospital-Cardiology ( Site 2000)

Guangzhou, Guangdong, China

Site Status

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

Changsha, Hunan, China

Site Status

Shanghai Pulmonary Hospital ( Site 2004)

Shanghai, Shanghai Municipality, China

Site Status

Yan an Hospital of Kunming City ( Site 2011)

Kunming, Yunnan, China

Site Status

Clinica Colsanitas - Sede Reina Sofia ( Site 0303)

Bogotá, Bogota D.C., Colombia

Site Status

Fundacion Santa Fe de Bogota ( Site 0302)

Bogotá, Bogota D.C., Colombia

Site Status

IMAT S.A.S ( Site 0301)

Montería, Departamento de Córdoba, Colombia

Site Status

Clínica Imbanaco S.A.S ( Site 0304)

Cali, Valle del Cauca Department, Colombia

Site Status

Vseobecna fakultni nemocnice v Praze ( Site 0400)

Prague, Praha 2, Czechia

Site Status

CHU Bordeaux Haut-Leveque ( Site 0501)

Pessac, Aquitaine, France

Site Status

C.H.U Hôpital Nord ( Site 0500)

Marseille, Bouches-du-Rhone, France

Site Status

CHU de Rouen ( Site 0503)

Rouen, Haute-Normandie, France

Site Status

CHU GABRIEL MONTPIED ( Site 0504)

Clermont-Ferrand, Puy-de-Dome, France

Site Status

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Családorvosi Intézet és Rendelő ( Site 0704)

Szeged, Csongrád megye, Hungary

Site Status

Semmelweis Egyetem ( Site 0701)

Budapest, Pest County, Hungary

Site Status

Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0702)

Budapest, Pest County, Hungary

Site Status

Rambam Health Care Campus ( Site 0802)

Haifa, , Israel

Site Status

Carmel Hospital ( Site 0803)

Haifa, , Israel

Site Status

Rabin Medical Center ( Site 0805)

Petah Tikva, , Israel

Site Status

Sheba Medical Center ( Site 0801)

Ramat Gan, , Israel

Site Status

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0902)

Milan, Lombardy, Italy

Site Status

Azienda Ospedaliera Universitaria Integrata ( Site 0908)

Verona, Veneto, Italy

Site Status

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

Bologna, , Italy

Site Status

Ospedale San Martino ( Site 0901)

Genova, , Italy

Site Status

Fondazione IRCCS Policlinico San Matteo ( Site 0909)

Pavia, , Italy

Site Status

AOU Policlinico Umberto I ( Site 0910)

Roma, , Italy

Site Status

Ospedale Civile SS Annunziata ( Site 0903)

Sassari, , Italy

Site Status

Nagoya University Hospital ( Site 2102)

Nagoya, Aichi-ken, Japan

Site Status

National Cerebral and Cardiovascular Center ( Site 2103)

Suita, Osaka, Japan

Site Status

The University of Tokyo Hospital ( Site 2101)

Bunkyo, Tokyo, Japan

Site Status

Kyorin University Hospital ( Site 2100)

Mitaka, Tokyo, Japan

Site Status

Kyushu University Hospital ( Site 2105)

Fukuoka, , Japan

Site Status

National Hospital Organization Okayama Medical Center ( Site 2104)

Okayama, , Japan

Site Status

Radboud University Medical Center ( Site 1001)

Nijmegen, Gelderland, Netherlands

Site Status

Sint Antonius Ziekenhuis ( Site 1000)

Nieuwegein, Utrecht, Netherlands

Site Status

National University Heart Centre, Singapore ( Site 1200)

Singapore, Central Singapore, Singapore

Site Status

National Heart Centre Singapore ( Site 1201)

Singapore, Central Singapore, Singapore

Site Status

Chonnam National University Hospital ( Site 1304)

Gwangju, Kwangju-Kwangyokshi, South Korea

Site Status

Pusan National University Hospital ( Site 1305)

Seogu, Pusan-Kwangyokshi, South Korea

Site Status

Seoul National University Hospital ( Site 1302)

Seoul, , South Korea

Site Status

Severance Hospital Yonsei University Health System ( Site 1300)

Seoul, , South Korea

Site Status

Asan Medical Center ( Site 1303)

Seoul, , South Korea

Site Status

Samsung Medical Center ( Site 1301)

Seoul, , South Korea

Site Status

Hospital Universitari Son Espases ( Site 1412)

Palma, Balearic Islands, Spain

Site Status

Hospital Universitario Marqués de Valdecilla ( Site 1405)

Santander, Cantabria, Spain

Site Status

Hospital Clinic de Barcelona ( Site 1406)

Barcelona, Catalonia, Spain

Site Status

Hospital Universitari Vall d''Hebron ( Site 1404)

Barcelona, , Spain

Site Status

Hospital Universitario 12 de Octubre ( Site 1403)

Madrid, , Spain

Site Status

Hospital Universitario La Paz ( Site 1410)

Madrid, , Spain

Site Status

Hospital Universitario Virgen del Rocio ( Site 1407)

Seville, , Spain

Site Status

HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1408)

Toledo, , Spain

Site Status

National Cheng Kung University Hospital ( Site 1501)

Tainan, , Taiwan

Site Status

Taipei Veterans General Hospital ( Site 1502)

Taipei, , Taiwan

Site Status

Faculty of Medicine Siriraj Hospital ( Site 1600)

Bangkoknoi, Bangkok, Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital ( Site 1601)

Muang, Chiang Mai, Thailand

Site Status

Royal Papworth Hospital ( Site 1802)

Cambridge, Cambridgeshire, United Kingdom

Site Status

Royal Free Hospital ( Site 1803)

London, England, United Kingdom

Site Status

Royal Brompton Hospital ( Site 1804)

London, London, City of, United Kingdom

Site Status

Hammersmith Hospital ( Site 1801)

London, London, City of, United Kingdom

Site Status

Golden Jubilee National Hospital ( Site 1800)

Glasgow, Scotland, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Canada China Colombia Czechia France Hungary Israel Italy Japan Netherlands Singapore South Korea Spain Taiwan Thailand United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MK-7962-031

Identifier Type: OTHER

Identifier Source: secondary_id

2024-518687-12-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1314-0614

Identifier Type: REGISTRY

Identifier Source: secondary_id

jRCT2061250021

Identifier Type: REGISTRY

Identifier Source: secondary_id

7962-031

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PAH Exercise Study
NCT06941441 RECRUITING PHASE3