CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 164 enrolled
Drug / intervention
Sotatercept 0.3 mg/kg +2 moredrug
Likely dose
Sotatercept 0.3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04945460
NCT04945460Phase 2Completed
CompareCT.gov

A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept Versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA·interventional·Posted Jun 30, 2021·Updated Apr 15, 2026

In Brief

A Phase 2 clinical trial evaluating Sotatercept 0.3 mg/kg, Placebo, and 1 other intervention for Hypertension, Pulmonary. Completed, enrolled 164 participants across 119 sites in 12 countries.

Detailed Summary

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Pulmonary
CountriesBelgium, Canada, France, Germany, Israel, Italy, Mexico, Poland, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJun 30, 2021
Enrollment StartDec 29, 2021
Primary CompletionSep 5, 2025
Study CompletionApr 9, 2026
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 5.0 years ago

Interventions

Sotatercept 0.3 mg/kgdrug

Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.

Placebodrug

Administered by subcutaneous injection

Sotatercept 0.3 mg/kg escalating to 0.7 mg/kgdrug

Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.