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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)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515773-99-00
Acronym
MK-7962-023
Enrollment
63
Registered
2025-04-28
Start date
2025-05-26
Completion date
Unknown
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Brief summary

Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE

Detailed description

Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 48, Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 48, Change From Baseline in the 6MWD at Week 126, Change From Baseline in the 6MWD at Week 174, Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 48, Change From Baseline in NYHA FC at Week 126, Change From Baseline in NYHA FC at Week 174, Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 48, Change From Baseline in NT-proBNP at Week 126, Change From Baseline in NT-proBNP at Week 174, Change From Week 24 in PVR at Week 48, Change From Week 24 in 6MWD at Week 48, Change From Week 24 in NYHA FC at Week 48

Interventions

DRUGSOTATERCEPT
DRUGsotatercept

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE—

Secondary

MeasureTime frame
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 48, Change From Baseline in the 6-Minute Walk Distance (6MWD) at Week 48, Change From Baseline in the 6MWD at Week 126, Change From Baseline in the 6MWD at Week 174, Change From Baseline in New York Heart Association Functional Class (NYHA FC) at Week 48, Change From Baseline in NYHA FC at Week 126, Change From Baseline in NYHA FC at Week 174, Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at Week 48, Change From Baseline in NT-proBNP at Week 126, Change From Baseline in NT-proBNP at Week 174, Change From Week 24 in PVR at Week 48, Change From Week 24 in 6MWD at Week 48, Change From Week 24 in NYHA FC at Week 48—

Countries

Belgium, France, Germany, Italy, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026