Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)

NCT06814145 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: 7962-023MK-7962-023U1111-1309-21422024-515773-99-00
• Study Type: interventional
• Target: 130
• Locations: 12 countries
• Sites: 56

Brief Summary

Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF). Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time. The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.

Conditions

Hypertension, Pulmonary

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experience an Adverse Event (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 experience an AE will be reported.

  Up to approximately 187 weeks

• Number of Participants Who Discontinue Study Treatment 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 treatment due to an AE will be reported.

  Up to approximately 168 weeks

Secondary Outcomes (13)

• Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 48

  Baseline and Week 48

• Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 48

  Baseline and Week 48

• Change From Baseline in the 6MWD at Week 126

  Baseline and Week 126

• Change From Baseline in the 6MWD at Week 174

  Baseline and Week 174

• Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 48

  Baseline and Week 48

Study Arms (2)

Sotatercept 0.3 mg/kg

EXPERIMENTAL

Participants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 168 weeks or until discontinuation.

Biological: Sotatercept

Sotatercept 0.7 mg/kg

EXPERIMENTAL

Participants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 168 weeks or until discontinuation.

Biological: Sotatercept

Interventions

Sotatercept BIOLOGICAL

subcutaneous injection

Also known as: ACE-011

Sotatercept 0.3 mg/kg; Sotatercept 0.7 mg/kg

Eligibility Criteria

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

You may qualify if:

• \- Completed MK-7962-007 (CADENCE) (Visit 9 and end of treatment \[EOT\] visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE)

You may not qualify if:

• Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
• Has had a study intervention interruption
• Is pregnant or breastfeeding
• Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy)
• Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair
• Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction)
• Anticipated or undergone heart transplant or ventricular assist device implantation
• Has had prior exposure to luspatercept

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (56)

Pulmonary Associates, PA ( Site 1008)

Phoenix, Arizona, 85032, United States

ACTIVE NOT RECRUITING

Jeffrey S. Sager, MD Medical Corporation ( Site 1060)

Santa Barbara, California, 93105, United States

ACTIVE NOT RECRUITING

Stanford University Medical Center ( Site 1024)

Stanford, California, 94305, United States

ACTIVE NOT RECRUITING

South Denver Cardiology Associates ( Site 1091)

Littleton, Colorado, 80120, United States

ACTIVE NOT RECRUITING

Yale New Haven Hospital ( Site 1093)

New Haven, Connecticut, 06520, United States

ACTIVE NOT RECRUITING

AdventHealth Orlando ( Site 1058)

Orlando, Florida, 32803, United States

ACTIVE NOT RECRUITING

The Emory Clinic ( Site 1030)

Atlanta, Georgia, 30322, United States

RECRUITING

Norton Pulmonary Specialists ( Site 1066)

Louisville, Kentucky, 40202, United States

ACTIVE NOT RECRUITING

University Of Nebraska Medical Center ( Site 1053)

Omaha, Nebraska, 68198, United States

ACTIVE NOT RECRUITING

Weill Cornell Medical Center ( Site 1046)

New York, New York, 10065, United States

ACTIVE NOT RECRUITING

Duke University Medical Center ( Site 1026)

Durham, North Carolina, 27710-4000, United States

RECRUITING

The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)

Cincinnati, Ohio, 45219, United States

RECRUITING

The Cleveland Clinic Foundation. ( Site 1065)

Cleveland, Ohio, 44195, United States

RECRUITING

The Ohio State University Wexner Medical Center ( Site 1032)

Columbus, Ohio, 43210, United States

RECRUITING

Allegheny General Hospital ( Site 1088)

Pittsburgh, Pennsylvania, 15212-4737, United States

ACTIVE NOT RECRUITING

Lankenau Medical Center ( Site 1089)

Wynnewood, Pennsylvania, 19096, United States

ACTIVE NOT RECRUITING

Rhode Island Hospital ( Site 1039)

Providence, Rhode Island, 02903, United States

ACTIVE NOT RECRUITING

Medical University of South Carolina ( Site 1003)

Charleston, South Carolina, 29425, United States

ACTIVE NOT RECRUITING

Statcare Pulmonary Consultants ( Site 1031)

Knoxville, Tennessee, 37919, United States

ACTIVE NOT RECRUITING

Intermountain Medical Center ( Site 1079)

Murray, Utah, 84107, United States

ACTIVE NOT RECRUITING

Inova Fairfax Medical Campus ( Site 1078)

Falls Church, Virginia, 22042, United States

ACTIVE NOT RECRUITING

Pulmonary Associates of Richmond - West Broad Street ( Site 1069)

Richmond, Virginia, 23230, United States

ACTIVE NOT RECRUITING

Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)

Brussels, Bruxelles-Capitale, Region de, 1070, Belgium

ACTIVE NOT RECRUITING

Hamilton Health Sciences Hamilton General Hospital ( Site 0004)

Hamilton, Ontario, L8L 2X2, Canada

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206)

Nice, Alpes-Maritimes, 06000, France

ACTIVE NOT RECRUITING

Hopital Arnaud de Villeneuve ( Site 0200)

Montpellier, Herault, 34295, France

ACTIVE NOT RECRUITING

Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 0205)

Saint-Herblain, Loire-Atlantique, 44800, France

ACTIVE NOT RECRUITING

Centre Hopitalier Universitaire d'Angers ( Site 0204)

Angers, Maine-et-Loire, 49100, France

ACTIVE NOT RECRUITING

CHU de Rouen ( Site 0203)

Rouen, Seine-Maritime, 76031, France

ACTIVE NOT RECRUITING

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202)

Le Kremlin-Bicêtre, Val-de-Marne, 94270, France

ACTIVE NOT RECRUITING

Thoraxklinik-Heidelberg gGmbH ( Site 0309)

Heidelberg, Baden-Wurttemberg, 69126, Germany

ACTIVE NOT RECRUITING

Krankenhaus Neuwittelsbach ( Site 0310)

München, Bavaria, 80639, Germany

RECRUITING

UKGM Gießen/Marburg ( Site 0312)

Giessen, Hesse, 35392, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Koeln ( Site 0311)

Cologne, North Rhine-Westphalia, 50937, Germany

ACTIVE NOT RECRUITING

Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315)

Mainz, Rhineland-Palatinate, 55131, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0301)

Dresden, Saxony, 01307, Germany

RECRUITING

DRK Kliniken Berlin Westend ( Site 0307)

Berlin, 14050, Germany

RECRUITING

Rambam Health Care Campus ( Site 0403)

Haifa, 3109601, Israel

ACTIVE NOT RECRUITING

Edith Wolfson Medical Center ( Site 0404)

Holon, 5810001, Israel

ACTIVE NOT RECRUITING

Hadassah Medical Center ( Site 0402)

Jerusalem, 9112001, Israel

ACTIVE NOT RECRUITING

Meir Medical Center ( Site 0401)

Kfar Saba, 4428164, Israel

ACTIVE NOT RECRUITING

ZIV Medical Center ( Site 0400)

Safed, 1311001, Israel

ACTIVE NOT RECRUITING

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502)

Bergamo, Lombardy, 24127, Italy

ACTIVE NOT RECRUITING

Fondazione IRCCS Policlinico San Matteo ( Site 0501)

Pavia, 27100, Italy

ACTIVE NOT RECRUITING

AOU Policlinico Umberto I ( Site 0500)

Roma, 00161, Italy

ACTIVE NOT RECRUITING

Unidad de Investigacion Clinica en Medicina, S.C. ( Site 2505)

Monterrey, Nuevo León, 64718, Mexico

RECRUITING

Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddzial Kliniczny Chorob Serca i Naczyn z Podod ( Site 0600)

Krakow, Lesser Poland Voivodeship, 31-202, Poland

ACTIVE NOT RECRUITING

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 0601)

Lublin, Lublin Voivodeship, 20-718, Poland

ACTIVE NOT RECRUITING

Uniwersytecki Szpital Kliniczny w Bialymstoku ( Site 0603)

Bialystok, Podlaskie Voivodeship, 15-276, Poland

ACTIVE NOT RECRUITING

Hospital Costa del Sol ( Site 0704)

Marbella, Malaga, 29603, Spain

ACTIVE NOT RECRUITING

Hospital Clinic I Provincial de Barcelona ( Site 0701)

Barcelona, 08036, Spain

ACTIVE NOT RECRUITING

Hospital Universitario 12 de Octubre ( Site 0702)

Madrid, 28041, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Virgen Macarena ( Site 0705)

Seville, 41009, Spain

ACTIVE NOT RECRUITING

HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703)

Toledo, 45007, Spain

ACTIVE NOT RECRUITING

Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)

Gothenburg, Västra Götaland County, 413 46, Sweden

ACTIVE NOT RECRUITING

Hammersmith Hospital-Department of Cardiology ( Site 0900)

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

ACTIVE NOT RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

ACE-011

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (3); PL (3); ES (5); ME (1); SE (1); BE (1); IL (5); US (22); DE (7); FR (6); CA (1); GB (1)