Phase 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept versus Placebo-Controlled 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

CTIS2023-509141-12-00

Acronym

A011-16

Enrollment

174

Registered

2024-09-12

Start date

2022-04-28

Completion date

Unknown

Last updated

2025-10-10

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

Conditions

Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF)

Brief summary

Change from baseline in PVR at Week 24

Detailed description

Time to clinical worsening at Wk 24: −Hospitalization cardiopulmonary indication −Administration IV diuretics or SC furosemide −Death −Decrease 6MWD by ≥ 15% from baseline • Change from baseline in: -hemodynamic and ECHO parameters at Wk 24 -NT-proBNP at Wk 24 - -NYHA FC at Wk 24, Cont. translations

Interventions

DRUGsotatercept

DRUGPL1 - Powder for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in PVR at Week 24	—

Secondary

Measure	Time frame
Time to clinical worsening at Wk 24: −Hospitalization cardiopulmonary indication −Administration IV diuretics or SC furosemide −Death −Decrease 6MWD by ≥ 15% from baseline • Change from baseline in: -hemodynamic and ECHO parameters at Wk 24 -NT-proBNP at Wk 24 - -NYHA FC at Wk 24, Cont. translations	—

Countries

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

Outcome results

None listed

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