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

NCT06925750 | Active Not Recruiting Phase 2 FDA Drug

• 5 other identifiers: 7962-031MK-7962-0312024-518687-12-00U1111-1314-0614jRCT2061250021
• Study Type: interventional
• Target: 130
• Locations: 19 countries
• Sites: 73

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Weight-banded sotatercept dosing

EXPERIMENTAL

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; Drug: Background PAH Therapy

Interventions

Sotatercept BIOLOGICAL

SC injection administered every 3 weeks

Also known as: MK-7962, ACE-011

Weight-banded sotatercept dosing

Background PAH Therapy 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

Weight-banded sotatercept dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (73)

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

Aurora, Colorado, 80045, United States

Location

University of Kansas Medical Center ( Site 1928)

Kansas City, Kansas, 66160, United States

Location

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

Albuquerque, New Mexico, 87131, United States

Location

Centro Medico Capital ( Site 0002)

La Plata, Buenos Aires, B1904AAW, Argentina

Location

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Location

Instituto Medico Rio Cuarto ( Site 0010)

Río Cuarto, Córdoba Province, X5800AEV, Argentina

Location

Instituto de Cardiologia Juana F. Cabral ( Site 0008)

Corrientes, W3400AMZ, Argentina

Location

Hospital Provincial Jose Maria Cullen ( Site 0005)

Santa Fe, S3000EOM, Argentina

Location

Royal Prince Alfred Hospital ( Site 0103)

Camperdown, New South Wales, 2050, Australia

Location

Westmead Hospital ( Site 0100)

Westmead, New South Wales, 2145, Australia

Location

Wesley Research Institute ( Site 0101)

Auchenflower, Queensland, 4066, Australia

Location

The Alfred Hospital ( Site 0102)

Melbourne, Victoria, 3004, Australia

Location

IUCPQ ( Site 0208)

Québec, Quebec, G1V 4G5, Canada

Location

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

Guangzhou, Guangdong, 510080, China

Location

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

Changsha, Hunan, 410011, China

Location

Shanghai Pulmonary Hospital ( Site 2004)

Shanghai, Shanghai Municipality, 200433, China

Location

Yan an Hospital of Kunming City ( Site 2011)

Kunming, Yunnan, 650051, China

Location

Clinica Colsanitas - Sede Reina Sofia ( Site 0303)

Bogotá, Bogota D.C., 110111, Colombia

Location

Fundacion Santa Fe de Bogota ( Site 0302)

Bogotá, Bogota D.C., 110111, Colombia

Location

IMAT S.A.S ( Site 0301)

Montería, Departamento de Córdoba, 230002, Colombia

Location

Clínica Imbanaco S.A.S ( Site 0304)

Cali, Valle del Cauca Department, 760042, Colombia

Location

Vseobecna fakultni nemocnice v Praze ( Site 0400)

Prague, Praha 2, 128 08, Czechia

Location

CHU Bordeaux Haut-Leveque ( Site 0501)

Pessac, Aquitaine, 33600, France

Location

C.H.U Hôpital Nord ( Site 0500)

Marseille, Bouches-du-Rhone, 13015, France

Location

CHU de Rouen ( Site 0503)

Rouen, Haute-Normandie, 76000, France

Location

CHU GABRIEL MONTPIED ( Site 0504)

Clermont-Ferrand, Puy-de-Dome, 63000, France

Location

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

Szeged, Csongrád megye, 6725, Hungary

Location

Semmelweis Egyetem ( Site 0701)

Budapest, Pest County, 1083, Hungary

Location

Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0702)

Budapest, Pest County, 1096, Hungary

Location

Rambam Health Care Campus ( Site 0802)

Haifa, 3109601, Israel

Location

Carmel Hospital ( Site 0803)

Haifa, 3436212, Israel

Location

Rabin Medical Center ( Site 0805)

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center ( Site 0801)

Ramat Gan, 5265601, Israel

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0902)

Milan, Lombardy, 20122, Italy

Location

Azienda Ospedaliera Universitaria Integrata ( Site 0908)

Verona, Veneto, 37126, Italy

Location

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

Bologna, 40139, Italy

Location

Ospedale San Martino ( Site 0901)

Genova, 16132, Italy

Location

Fondazione IRCCS Policlinico San Matteo ( Site 0909)

Pavia, 27100, Italy

Location

AOU Policlinico Umberto I ( Site 0910)

Roma, 00161, Italy

Location

Ospedale Civile SS Annunziata ( Site 0903)

Sassari, 07100, Italy

Location

Nagoya University Hospital ( Site 2102)

Nagoya, Aichi-ken, 466-8560, Japan

Location

National Cerebral and Cardiovascular Center ( Site 2103)

Suita, Osaka, 564-8565, Japan

Location

The University of Tokyo Hospital ( Site 2101)

Bunkyo, Tokyo, 113-8655, Japan

Location

Kyorin University Hospital ( Site 2100)

Mitaka, Tokyo, 181-8611, Japan

Location

Kyushu University Hospital ( Site 2105)

Fukuoka, 812-8582, Japan

Location

National Hospital Organization Okayama Medical Center ( Site 2104)

Okayama, 701-1192, Japan

Location

Radboud University Medical Center ( Site 1001)

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Sint Antonius Ziekenhuis ( Site 1000)

Nieuwegein, Utrecht, 3435CM, Netherlands

Location

National University Heart Centre, Singapore ( Site 1200)

Singapore, Central Singapore, 119074, Singapore

Location

National Heart Centre Singapore ( Site 1201)

Singapore, Central Singapore, 169609, Singapore

Location

Chonnam National University Hospital ( Site 1304)

Gwangju, Kwangju-Kwangyokshi, 61469, South Korea

Location

Pusan National University Hospital ( Site 1305)

Seogu, Pusan-Kwangyokshi, 49241, South Korea

Location

Seoul National University Hospital ( Site 1302)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 1300)

Seoul, 03722, South Korea

Location

Asan Medical Center ( Site 1303)

Seoul, 05505, South Korea

Location

Samsung Medical Center ( Site 1301)

Seoul, 06351, South Korea

Location

Hospital Universitari Son Espases ( Site 1412)

Palma, Balearic Islands, 07120, Spain

Location

Hospital Universitario Marqués de Valdecilla ( Site 1405)

Santander, Cantabria, 39008, Spain

Location

Hospital Clinic de Barcelona ( Site 1406)

Barcelona, Catalonia, 08036, Spain

Location

Hospital Universitari Vall d''Hebron ( Site 1404)

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre ( Site 1403)

Madrid, 28041, Spain

Location

Hospital Universitario La Paz ( Site 1410)

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocio ( Site 1407)

Seville, 41013, Spain

Location

HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1408)

Toledo, 45007, Spain

Location

National Cheng Kung University Hospital ( Site 1501)

Tainan, 704302, Taiwan

Location

Taipei Veterans General Hospital ( Site 1502)

Taipei, 112201, Taiwan

Location

Faculty of Medicine Siriraj Hospital ( Site 1600)

Bangkoknoi, Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital ( Site 1601)

Muang, Chiang Mai, 50200, Thailand

Location

Royal Papworth Hospital ( Site 1802)

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

Location

Royal Free Hospital ( Site 1803)

London, England, NW3 2QG, United Kingdom

Location

Royal Brompton Hospital ( Site 1804)

London, London, City of, SW3 6HP, United Kingdom

Location

Hammersmith Hospital ( Site 1801)

London, London, City of, W12 OHS, United Kingdom

Location

Golden Jubilee National Hospital ( Site 1800)

Glasgow, Scotland, G81 4DY, United Kingdom

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

ACE-011

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): June 16, 2028
• Study Completion (Estimated): June 16, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CO (4); JP (6); CA (1); HU (3); IL (4); IT (7); SG (2); AR (5); TH (2); AU (4); NL (2); KR (6); GB (5); CZ (1); FR (4); TW (2); US (3); CN (4); ES (8)