NCT04896008

A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk Mortality

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus maximum tolerated background pulmonary arterial hypertension \[PAH\] therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality.

Detailed description

This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate sotatercept when added to maximum tolerated background PAH therapy on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥24 hours, in participants with WHO FC III PAH or WHO FC IV PAH at high risk of mortality. Participants who were eligible for this study presented with symptomatic PAH that was classified as idiopathic, heritable, drug- or toxin-induced, associated with connective tissue disease, or post-shunt correction.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Sotatercept	SC injection
OTHER	Placebo	Placebo-matched SC injection

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-07-26
• Completion: 2025-02-18
• First posted: 2021-05-21
• Last updated: 2026-03-02
• Results posted: 2025-08-22

Locations

57 sites across 12 countries: United States, Australia, Belgium, Canada, France, Germany, Israel, Italy, Mexico, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study