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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2

Conditions: Hypertension, Pulmonary

Treatments: Biological: Sotatercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT06814145

2024-515773-99 (Other Identifier)

MK-7962-023 (Other Identifier)

U1111-1309-2142 (Other Identifier)

7962-023

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups

Sotatercept 0.3 mg/kg

Experimental group

Description:

Participants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 168 weeks or until discontinuation.

Treatment:

Biological: Sotatercept

Sotatercept 0.7 mg/kg

Experimental group

Description:

Participants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 168 weeks or until discontinuation.

Treatment:

Biological: Sotatercept