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

Phase 2

Recruiting

• Conditions: Hypertension, Pulmonary
• Interventions: Biological: Sotatercept

• Registration Number: NCT06814145
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Study First Posted: 2025-02-07
• Status Verified: 2025-04
• Study Start: 2025-04-16
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2029-03-30
• Study Completion: 2029-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sotatercept 0.3 mg/kg	Sotatercept	Participants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 168 weeks or until discontinuation.
Sotatercept 0.7 mg/kg	Sotatercept	Participants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 168 weeks or until discontinuation.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 187 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE	Up to approximately 168 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 48	Baseline and Week 48	PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from baseline in PVR at Week 48 will be presented.
Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 48	Baseline and Week 48	The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Week 48 will be presented.
Change From Baseline in the 6MWD at Week 126	Baseline and Week 126	The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Week 126 will be presented.
Change From Baseline in the 6MWD at Week 174	Baseline and Week 174	The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Week 174 will be presented.
Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 48	Baseline and Week 48	NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Week 48 will be presented.
Change From Baseline in NYHA FC at Week 126	Baseline and Week 126	NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Week 126 will be presented.
Change From Baseline in NYHA FC at Week 174	Baseline and Week 174	NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Week 174 will be presented.
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 48	Baseline and Week 48	NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP will be measured at baseline and at Week 48. The change from baseline in NT-proBNP at Week 48 will be presented.
Change From Baseline in NT-proBNP at Week 126	Baseline and Week 126	NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP will be measured at baseline and at Week 126. The change from baseline in NT-proBNP at Week 126 will be presented.
Change From Baseline in NT-proBNP at Week 174	Baseline and Week 174	NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. NT-proBNP will be measured at baseline and at Week 174. The change from baseline in NT-proBNP at Week 174 will be presented.
Change From Week 24 in PVR at Week 48	Week 24 and Week 48	PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from Week 24 in PVR at Week 48 will be presented.
Change From Week 24 in 6MWD at Week 48	Week 24 and Week 48	The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from Week 24 in 6MWD at Week 48 will be presented.
Change From Week 24 in NYHA FC at Week 48	Week 24 and Week 48	NYHA FC classifies the extent of heart failure. The change from Week 24 in NYHA FC at Week 48 will be presented.

Trial Locations

Locations (1)

Pulmonary Associates, PA ( Site 1008); 🇺🇸 Phoenix, Arizona, United States