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

Running, not enrolling · Phase 2

Conditions studied: Hypertension, Pulmonary

In brief

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.

Key facts

Study ID

NCT06814145

Run by

Merck Sharp & Dohme LLC

People needed

440

Starts

2025-04-16

Expected to finish

2035-08-10

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The main inclusion criteria include but are not limited to the following:
• Completed sotatercept parent study (MK-7962-007[CADENCE] [Visit 9 and EOT visit] or MK-7962-041 [P041] [EOT Visit]) without discontinuing study intervention and is able to safely enroll into MK-7962-023 (HARMONIZE)

You may not qualify if…

• 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 and has an ongoing SAE that occurred during parent study and is suspected to be related to study intervention
• 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

Where it is running

• Scripps Clinic John R Anderson V Medical Pavillion ( Site 1004) — La Jolla, California, United States
• Jeffrey S. Sager, MD Medical Corporation ( Site 1060) — Santa Barbara, California, United States
• Stanford University Medical Center ( Site 1024) — Stanford, California, United States
• South Denver Cardiology Associates ( Site 1091) — Littleton, Colorado, United States
• Yale New Haven Hospital ( Site 1093) — New Haven, Connecticut, United States
• AdventHealth Orlando ( Site 1058) — Orlando, Florida, United States
• The Emory Clinic ( Site 1030) — Atlanta, Georgia, United States
• Norton Pulmonary Specialists ( Site 1066) — Louisville, Kentucky, United States
• University Of Nebraska Medical Center ( Site 1053) — Omaha, Nebraska, United States
• Weill Cornell Medical Center ( Site 1046) — New York, New York, United States
• Duke University Medical Center ( Site 1026) — Durham, North Carolina, United States
• The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001) — Cincinnati, Ohio, United States
• The Cleveland Clinic Foundation. ( Site 1065) — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center ( Site 1032) — Columbus, Ohio, United States
• Allegheny General Hospital ( Site 1088) — Pittsburgh, Pennsylvania, United States
• Lankenau Medical Center ( Site 1089) — Wynnewood, Pennsylvania, United States
• Rhode Island Hospital ( Site 1039) — Providence, Rhode Island, United States
• Medical University of South Carolina ( Site 1003) — Charleston, South Carolina, United States
• Statcare Pulmonary Consultants ( Site 1031) — Knoxville, Tennessee, United States
• Intermountain Medical Center ( Site 1079) — Murray, Utah, United States
• Inova Fairfax Medical Campus ( Site 1078) — Falls Church, Virginia, United States
• Pulmonary Associates of Richmond - West Broad Street ( Site 1069) — Richmond, Virginia, United States
• Université Libre de Bruxelles - Hôpital Erasme ( Site 0100) — Brussels, Bruxelles-Capitale, Region de, Belgium
• Hamilton Health Sciences Hamilton General Hospital ( Site 0004) — Hamilton, Ontario, Canada
• Pulmonary Associates, PA ( Site 1008) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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