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

A Phase 2, Multicenter, Open-label Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) With Heart Failure With Preserved Ejection Fraction (HFpEF)

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.

This is an extension study for studies MK-7962-007 (NCT04945460) and MK-7962-041 (NCT number pending).

Following protocol amendment 3, all participants in the Sotatercept 0.7 mg/kg arm will switch to the Sotatercept 0.3 mg/kg arm, and new participants will only enroll in the Sotatercept 0.3 mg/kg arm.

Inclusion Criteria:

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)

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 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