RecruitingPhase 2

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

United States130 participantsStarted 2025-04-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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 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

What they're measuring

Number of Participants Who Experience an Adverse Event (AE)

Timeframe: Up to approximately 187 weeks

Number of Participants Who Discontinue Study Treatment Due to an AE

Timeframe: Up to approximately 168 weeks

Trial details

NCT IDNCT06814145

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-03-30

Contact for this trial

Toll Free Number

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