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

Last updated: June 17, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Circulation Disorders

Vascular Diseases

Williams Syndrome

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) withoutdiscontinuing 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

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

    Nice, Alpes-Maritimes 6000
    France

    Active - Recruiting

  • Centre Hopitalier Universitaire d'Angers ( Site 0204)

    Angers, Maine-et-Loire 49100
    France

    Site Not Available

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

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

    Active - Recruiting

  • Thoraxklinik-Heidelberg gGmbH ( Site 0309)

    Heidelberg, Baden-Wurttemberg 69126
    Germany

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo ( Site 0501)

    Pavia, 27100
    Italy

    Active - Recruiting

  • Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)

    Goteborg, Vastra Gotalands Lan 413 46
    Sweden

    Active - Recruiting

  • Pulmonary Associates, PA ( Site 1008)

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • South Denver Cardiology Associates ( Site 1091)

    Littleton, Colorado 80120
    United States

    Active - Recruiting

  • University Of Nebraska Medical Center ( Site 1053)

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Lankenau Medical Center ( Site 1089)

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

  • Statcare Pulmonary Consultants ( Site 1031)

    Knoxville, Tennessee 37919
    United States

    Active - Recruiting

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

    Richmond, Virginia 23230
    United States

    Active - Recruiting

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