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

Last updated: March 25, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Williams Syndrome

Vascular Diseases

Circulation Disorders

Treatment

Sotatercept

Clinical Study ID

NCT06814145
7962-023
MK-7962-023
U1111-1309-2142
2024-515773-99-00
2024-515773-99
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • 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)

Exclusion

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • 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 orbiomechanical) and/or have undergone more than 1 valve replacement or repair

  • Has severe tricuspid regurgitation due to primary valvular disease (eg, fromendocarditis, carcinoid, or mechanical destruction)

  • Anticipated or undergone heart transplant or ventricular assist device implantation

  • Has had prior exposure to luspatercept

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: Sotatercept
Phase: 2
Study Start date:
April 16, 2025
Estimated Completion Date:
March 30, 2029

Connect with a study center

  • Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)

    Brussels, Bruxelles-Capitale, Region de 1070
    Belgium

    Site Not Available

  • Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)

    Brussels 2800866, Bruxelles-Capitale, Region de 1070
    Belgium

    Site Not Available

  • Hamilton Health Sciences Hamilton General Hospital ( Site 0004)

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • Hamilton Health Sciences Hamilton General Hospital ( Site 0004)

    Hamilton 5969782, Ontario 6093943 L8L 2X2
    Canada

    Site Not Available

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

    Nice, Alpes-Maritimes 06000
    France

    Site Not Available

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

    Nice 2990440, Alpes-Maritimes 06000
    France

    Site Not Available

  • Hopital Arnaud de Villeneuve ( Site 0200)

    Montpellier, Herault 34295
    France

    Site Not Available

  • Hopital Arnaud de Villeneuve ( Site 0200)

    Montpellier 2992166, Herault 34295
    France

    Site Not Available

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

    Saint-Herblain, Loire-Atlantique 44800
    France

    Site Not Available

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

    Saint-Herblain 2979590, Loire-Atlantique 44800
    France

    Site Not Available

  • Centre Hopitalier Universitaire d'Angers ( Site 0204)

    Angers, Maine-et-Loire 49100
    France

    Site Not Available

  • Centre Hopitalier Universitaire d'Angers ( Site 0204)

    Angers 3037656, Maine-et-Loire 49100
    France

    Site Not Available

  • CHU de Rouen ( Site 0203)

    Rouen, Seine-Maritime 76031
    France

    Site Not Available

  • CHU de Rouen ( Site 0203)

    Rouen 2982652, Seine-Maritime 76031
    France

    Site Not Available

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202)

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

    Site Not Available

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202)

    Le Kremlin-Bicêtre 3003737, Val-de-Marne 94270
    France

    Site Not Available

  • Thoraxklinik-Heidelberg gGmbH ( Site 0309)

    Heidelberg, Baden-Wurttemberg 69126
    Germany

    Site Not Available

  • Thoraxklinik-Heidelberg gGmbH ( Site 0309)

    Heidelberg 2907911, Baden-Wurttemberg 2953481 69126
    Germany

    Site Not Available

  • Krankenhaus Neuwittelsbach ( Site 0310)

    München, Bavaria 80639
    Germany

    Active - Recruiting

  • Krankenhaus Neuwittelsbach ( Site 0310)

    München 2867713, Bavaria 2951839 80639
    Germany

    Site Not Available

  • UKGM Gießen/Marburg ( Site 0312)

    Giessen, Hesse 35392
    Germany

    Site Not Available

  • UKGM Gießen/Marburg ( Site 0312)

    Giessen 2920512, Hesse 2905330 35392
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln ( Site 0311)

    Cologne, North Rhine-Westphalia 50937
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln ( Site 0311)

    Cologne 2886242, North Rhine-Westphalia 2861876 50937
    Germany

    Site Not Available

  • Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315)

    Mainz, Rhineland-Palatinate 55131
    Germany

    Site Not Available

  • Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315)

    Mainz 2874225, Rhineland-Palatinate 2847618 55131
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0301)

    Dresden, Saxony 01307
    Germany

    Active - Recruiting

  • Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0301)

    Dresden 2935022, Saxony 2842566 01307
    Germany

    Site Not Available

  • DRK Kliniken Berlin Westend ( Site 0307)

    Berlin, 14050
    Germany

    Active - Recruiting

  • Rambam Health Care Campus ( Site 0403)

    Haifa, 3109601
    Israel

    Site Not Available

  • Rambam Health Care Campus ( Site 0403)

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • Edith Wolfson Medical Center ( Site 0404)

    Holon, 5810001
    Israel

    Site Not Available

  • Edith Wolfson Medical Center ( Site 0404)

    Holon 294751, 5810001
    Israel

    Site Not Available

  • Hadassah Medical Center ( Site 0402)

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Hadassah Medical Center ( Site 0402)

    Jerusalem 281184, 9112001
    Israel

    Site Not Available

  • Meir Medical Center ( Site 0401)

    Kfar Saba, 4428164
    Israel

    Site Not Available

  • Meir Medical Center ( Site 0401)

    Kfar Saba 294514, 4428164
    Israel

    Site Not Available

  • ZIV Medical Center ( Site 0400)

    Safed, 1311001
    Israel

    Site Not Available

  • ZIV Medical Center ( Site 0400)

    Safed 293100, 1311001
    Israel

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502)

    Bergamo, Lombardy 24127
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502)

    Bergamo 3182164, Lombardy 3174618 24127
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo ( Site 0501)

    Pavia, 27100
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo ( Site 0501)

    Pavia 3171366, 27100
    Italy

    Site Not Available

  • AOU Policlinico Umberto I ( Site 0500)

    Roma, 00161
    Italy

    Site Not Available

  • AOU Policlinico Umberto I ( Site 0500)

    Roma 8957247, 00161
    Italy

    Site Not Available

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

    Monterrey, Nuevo León 64718
    Mexico

    Active - Recruiting

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

    Monterrey 3995465, Nuevo León 3522542 64718
    Mexico

    Site Not Available

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

    Krakow, Lesser Poland Voivodeship 31-202
    Poland

    Site Not Available

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

    Krakow 3094802, Lesser Poland Voivodeship 858786 31-202
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 0601)

    Lublin, Lublin Voivodeship 20-718
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 0601)

    Lublin 765876, Lublin Voivodeship 858785 20-718
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku ( Site 0603)

    Bialystok, Podlaskie Voivodeship 15-276
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku ( Site 0603)

    Bialystok 776069, Podlaskie Voivodeship 858789 15-276
    Poland

    Site Not Available

  • Hospital Costa del Sol ( Site 0704)

    Marbella, Malaga 29603
    Spain

    Site Not Available

  • Hospital Costa del Sol ( Site 0704)

    Marbella 2514169, Malaga 29603
    Spain

    Site Not Available

  • Hospital Clinic I Provincial de Barcelona ( Site 0701)

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Clinic I Provincial de Barcelona ( Site 0701)

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre ( Site 0702)

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre ( Site 0702)

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena ( Site 0705)

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena ( Site 0705)

    Seville, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena ( Site 0705)

    Seville 2510911, 41009
    Spain

    Site Not Available

  • HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703)

    Toledo, 45007
    Spain

    Site Not Available

  • HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703)

    Toledo 2510409, 45007
    Spain

    Site Not Available

  • Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)

    Goteborg, Vastra Gotalands Lan 413 46
    Sweden

    Site Not Available

  • Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)

    Gothenburg, Västra Götaland County 413 46
    Sweden

    Site Not Available

  • Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)

    Gothenburg 2711537, Västra Götaland County 3337386 413 46
    Sweden

    Site Not Available

  • Hammersmith Hospital-Department of Cardiology ( Site 0900)

    London, London, City of W12 OHS
    United Kingdom

    Site Not Available

  • Hammersmith Hospital-Department of Cardiology ( Site 0900)

    London 2643743, London, City of W12 OHS
    United Kingdom

    Site Not Available

  • Pulmonary Associates, PA ( Site 1008)

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Pulmonary Associates, PA ( Site 1008)

    Phoenix 5308655, Arizona 5551752 85032
    United States

    Site Not Available

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

    Santa Barbara, California 93105
    United States

    Site Not Available

  • Stanford University Medical Center ( Site 1024)

    Stanford, California 94305
    United States

    Site Not Available

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

    Santa Barbara 5392952, California 5332921 93105
    United States

    Site Not Available

  • Stanford University Medical Center ( Site 1024)

    Stanford 5398563, California 5332921 94305
    United States

    Site Not Available

  • South Denver Cardiology Associates ( Site 1091)

    Littleton, Colorado 80120
    United States

    Site Not Available

  • South Denver Cardiology Associates ( Site 1091)

    Littleton 5429032, Colorado 5417618 80120
    United States

    Site Not Available

  • Yale New Haven Hospital ( Site 1093)

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Yale New Haven Hospital ( Site 1093)

    New Haven 4839366, Connecticut 4831725 06520
    United States

    Site Not Available

  • AdventHealth Orlando ( Site 1058)

    Orlando, Florida 32803
    United States

    Site Not Available

  • AdventHealth Orlando ( Site 1058)

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • The Emory Clinic ( Site 1030)

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • The Emory Clinic ( Site 1030)

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Norton Pulmonary Specialists ( Site 1066)

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Pulmonary Specialists ( Site 1066)

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • University Of Nebraska Medical Center ( Site 1053)

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • University Of Nebraska Medical Center ( Site 1053)

    Omaha 5074472, Nebraska 5073708 68198
    United States

    Site Not Available

  • Weill Cornell Medical Center ( Site 1046)

    New York, New York 10065
    United States

    Site Not Available

  • Weill Cornell Medical Center ( Site 1046)

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • Duke University Medical Center ( Site 1026)

    Durham, North Carolina 27710-4000
    United States

    Active - Recruiting

  • Duke University Medical Center ( Site 1026)

    Durham 4464368, North Carolina 4482348 27710-4000
    United States

    Site Not Available

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

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • The Cleveland Clinic Foundation. ( Site 1065)

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center ( Site 1032)

    Columbus, Ohio 43210
    United States

    Active - Recruiting

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

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • The Cleveland Clinic Foundation. ( Site 1065)

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center ( Site 1032)

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • Allegheny General Hospital ( Site 1088)

    Pittsburgh, Pennsylvania 15212-4737
    United States

    Site Not Available

  • Lankenau Medical Center ( Site 1089)

    Wynnewood, Pennsylvania 19096
    United States

    Site Not Available

  • Allegheny General Hospital ( Site 1088)

    Pittsburgh 5206379, Pennsylvania 6254927 15212-4737
    United States

    Site Not Available

  • Lankenau Medical Center ( Site 1089)

    Wynnewood 5220230, Pennsylvania 6254927 19096
    United States

    Site Not Available

  • Rhode Island Hospital ( Site 1039)

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Rhode Island Hospital ( Site 1039)

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Site Not Available

  • Medical University of South Carolina ( Site 1003)

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina ( Site 1003)

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Statcare Pulmonary Consultants ( Site 1031)

    Knoxville, Tennessee 37919
    United States

    Site Not Available

  • Statcare Pulmonary Consultants ( Site 1031)

    Knoxville 4634946, Tennessee 4662168 37919
    United States

    Site Not Available

  • Intermountain Medical Center ( Site 1079)

    Murray, Utah 84107
    United States

    Site Not Available

  • Intermountain Medical Center ( Site 1079)

    Murray 5778755, Utah 5549030 84107
    United States

    Site Not Available

  • Inova Fairfax Medical Campus ( Site 1078)

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Inova Heart and Vascular Institute ( Site 1078)

    Falls Church, Virginia 22042
    United States

    Site Not Available

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

    Richmond, Virginia 23230
    United States

    Site Not Available

  • Inova Fairfax Medical Campus ( Site 1078)

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Site Not Available

  • Inova Heart and Vascular Institute ( Site 1078)

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Active - Recruiting

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

    Richmond 4781708, Virginia 6254928 23230
    United States

    Site Not Available

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