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

NCT06664801 | Completed Phase 2 FDA Drug

• 5 other identifiers: 7962-0242024-512278-92-00U1111-1304-7985MK-7962-024jRCT2061240077
• Study Type: interventional
• Target: 164
• Locations: 21 countries
• Sites: 98

Brief 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. 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

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (3)

• Steady-State Average Serum Concentrations of Sotatercept (Cavg)

  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)

  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

  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 Outcomes (1)

• Initial Dose Average Serum Concentrations of Sotatercept (Cavg)

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

Study Arms (2)

Weight-based sotatercept dosing

EXPERIMENTAL

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; Biological: Background PAH Therapy

Weight-banded sotatercept dosing

EXPERIMENTAL

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; Biological: Background PAH Therapy

Interventions

Sotatercept BIOLOGICAL

SC administered every 3 weeks.

Also known as: MK-7962

Weight-banded sotatercept dosing; Weight-based sotatercept dosing

Background PAH Therapy BIOLOGICAL

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; Weight-based 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 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

You may not qualify if:

• Has a weight of \<35 kg
• Has a diagnosis of PH WHO Groups 2, 3, 4, or 5
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (98)

Pulmonary Associates, PA ( Site 1903)

Phoenix, Arizona, 85032, United States

Location

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

Aurora, Colorado, 80045, United States

Location

Indiana University Health Methodist Hospital ( Site 1905)

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center ( Site 1928)

Kansas City, Kansas, 66160, United States

Location

Norton Pulmonary Specialists ( Site 1935)

Louisville, Kentucky, 40202, United States

Location

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

Albuquerque, New Mexico, 87131, United States

Location

University of Cincinnati Medical Center ( Site 1927)

Cincinnati, Ohio, 45219, United States

Location

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

Austin, Texas, 78705, United States

Location

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

Milwaukee, Wisconsin, 53226, 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

Hospital Britanico de Buenos Aires ( Site 0004)

CABA, C1280AEB, Argentina

Location

Instituto de Cardiologia Juana F. Cabral ( Site 0008)

Corrientes, W3400AMZ, Argentina

Location

Hospital Provincial Jose Maria Cullen ( Site 0005)

Santa Fe, 3000, 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

Peter Lougheed Centre ( Site 0203)

Calgary, Alberta, T1Y 6J4, Canada

Location

IUCPQ ( Site 0208)

Québec, Quebec, G1V 4G5, Canada

Location

Guangdong Provincial People s Hospital ( 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 Cardio VID ( Site 0307)

Medellín, Antioquia, 050034, Colombia

Location

Clinica Colsanitas - Sede Reina Sofia ( Site 0303)

Bogotá, Bogota D.C., 110111, Colombia

Location

Fundacion Santa Fe de Bogota ( Site 0302)

Bogota, Cundinamarca, 110111, Colombia

Location

IMAT S.A.S ( Site 0301)

Montería, Departamento de Córdoba, 230002, Colombia

Location

Centro de Investigaciones Clinicas SAS ( Site 0306)

Cali, Valle del Cauca Department, 760036, Colombia

Location

Clínica Imbanaco S.A.S ( Site 0304)

Cali, Valle del Cauca Department, 760042, Colombia

Location

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

Prague, Praha 2, 128 08, Czechia

Location

CHU Bordeaux Haut-Leveque ( Site 0501)

Pessac, Aquitaine, 33604, France

Location

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

Marseille, Bouches-du-Rhone, 13015, France

Location

CHU Dijon Bourgogne ( Site 0502)

Dijon, Cote-d Or, 21079, France

Location

CHU de Rouen ( Site 0503)

Rouen, Haute-Normandie, 76000, France

Location

CHU GABRIEL MONTPIED ( Site 0504)

Clermont-Ferrand, Puy-de-Dome, 63003, France

Location

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

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Klinikum der Universität München Großhadern ( Site 0611)

München, Bavaria, 81377, Germany

Location

Medizinische Hochschule Hannover ( Site 0604)

Hanover, Lower Saxony, 30625, Germany

Location

Universitätsklinikum Bonn ( Site 0608)

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0609)

Berlin, 10117, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf ( Site 0610)

Hamburg, 20246, Germany

Location

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

Szeged, Csongrád megye, 6725, Hungary

Location

Pécsi Tudományegyetem Klinikai Központ ( Site 0703)

Pécs, Pecs, 7624, Hungary

Location

Semmelweis Egyetem ( Site 0701)

Budapest, Pest County, 1083, Hungary

Location

Gottsegen Gyorgy Orszagos Kardiologiai Intezet ( Site 0702)

Budapest, 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

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

Bologna, Emilia-Romagna, 40138, Italy

Location

AOU Policlinico Umberto I ( Site 0910)

Rome, Lazio, 00161, Italy

Location

Ospedale San Martino ( Site 0901)

Genoa, Liguria, 16132, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda ( Site 0900)

Milan, Lombardy, 20162, Italy

Location

Fondazione IRCCS San Gerardo dei Tintori ( Site 0911)

Monza, Lombardy, 20900, Italy

Location

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

Turin, Piedmont, 10126, Italy

Location

Azienda Ospedaliera Universitaria Integrata ( Site 0908)

Verona, Veneto, 37126, Italy

Location

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

Milan, 20122, Italy

Location

Fondazione IRCCS Policlinico San Matteo ( Site 0909)

Pavia, 27100, Italy

Location

Fondazione G. Monasterio ( Site 0907)

Pisa, 56124, 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

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

Krakow, Lesser Poland Voivodeship, 31-202, Poland

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 (CNUH) ( Site 1304)

Gwangju, Kwangju-Kwangyokshi, 61469, South Korea

Location

Pusan National University Hospital ( Site 1305)

Busan, 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 Marques de Valdecilla ( Site 1405)

Santander, Cantabria, 39008, Spain

Location

Hospital Clinic de Barcelona ( Site 1406)

Barcelona, Catalonia, 08036, Spain

Location

Hospital Vall D Hebron ( Site 1404)

Barcelona, 08035, Spain

Location

Hospital Ramon y Cajal ( Site 1401)

Madrid, 28034, Spain

Location

Hospital General Universitario 12 de Octubre ( Site 1403)

Madrid, 28041, Spain

Location

Hospital Universitario La Paz ( Site 1410)

Madrid, 28046, Spain

Location

Hospital Virgen del Rocio ( Site 1407)

Seville, 41013, Spain

Location

Hospital Universitario de Toledo ( Site 1408)

Toledo, 45007, Spain

Location

Kaohsiung Veterans General Hospital ( Site 1503)

Kaohsiung City, 813414, Taiwan

Location

National Cheng Kung University Hospital ( Site 1501)

Tainan, 70403, Taiwan

Location

Taipei Veterans General Hospital ( Site 1502)

Taipei, 11217, Taiwan

Location

Faculty of Medicine Siriraj Hospital ( Site 1600)

Bangkok, Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital ( Site 1601)

Chiang Mai, 50200, Thailand

Location

Royal Papworth Hospital ( Site 1802)

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

Location

Royal Free London NHS Foundation Trust ( Site 1803)

London, London, City of, NW3 2QG, United Kingdom

Location

Royal Brompton Hospital ( Site 1804)

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

Location

Hammersmith Hospital ( Site 1801)

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

Location

Golden Jubilee National Hospital ( Site 1800)

Glasgow, West Dunbartonshire, G81 4DY, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: November 14, 2024
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

IT (11); CN (4); TW (3); ES (9); AU (4); HU (4); PL (1); GB (5); AR (6); TH (2); IL (4); JP (6); SG (2); CA (2); CO (6); NL (2); KR (6); FR (5); CZ (1); DE (6); US (9)