Clinical trial NCT06814145: Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
Official title: A Phase 2, Multicenter, Double-blind, Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hypertension, Pulmonary
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 187 weeks
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 168 weeks
Secondary outcomes:
measure: Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in the 6MWD at Week 126
timeFrame: Baseline and Week 126
measure: Change From Baseline in the 6MWD at Week 174
timeFrame: Baseline and Week 174
measure: Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in NYHA FC at Week 126
timeFrame: Baseline and Week 126
measure: Change From Baseline in NYHA FC at Week 174
timeFrame: Baseline and Week 174
measure: Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in NT-proBNP at Week 126
timeFrame: Baseline and Week 126
measure: Change From Baseline in NT-proBNP at Week 174
timeFrame: Baseline and Week 174
measure: Change From Week 24 in PVR at Week 48
timeFrame: Week 24 and Week 48
measure: Change From Week 24 in 6MWD at Week 48
timeFrame: Week 24 and Week 48
measure: Change From Week 24 in NYHA FC at Week 48
timeFrame: Week 24 and Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates, PA ( Site 1008)
state: Arizona
city: Littleton
country: United States
facility: South Denver Cardiology Associates ( Site 1091)
state: Colorado
city: Omaha
country: United States
facility: University Of Nebraska Medical Center ( Site 1053)
state: Nebraska
city: Wynnewood
country: United States
facility: Lankenau Medical Center ( Site 1089)
state: Pennsylvania
city: Knoxville
country: United States
facility: Statcare Pulmonary Consultants ( Site 1031)
state: Tennessee
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond - West Broad Street ( Site 1069)
state: Virginia
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206)
state: Alpes-Maritimes
city: Angers
country: France
facility: Centre Hopitalier Universitaire d'Angers ( Site 0204)
state: Maine-et-Loire
city: Le Kremlin-Bicêtre
country: France
facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202)
state: Val-de-Marne
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH ( Site 0309)
state: Baden-Wurttemberg
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo ( Site 0501)
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)
state: Vastra Gotalands Lan
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: