Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

Phase 3 Terminated 321 enrolled Acceleron Pharma, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension \[PAH\] therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high-risk of disease progression.

Timeline

Start: 2022-03-18
Primary completion: 2025-04-03
Completion: 2025-04-03

Outcome

Met primary endpoint

Stopped: “Study was stopped early due to loss of clinical equipoise based on robust evidence of clinical benefit of sotatercept demonstrated in previous studies.”

registry Sotatercept Plus Background Pulmonary Arterial Hypertension (PAH) Therapy vs Placebo Plus Background PAH Therapy; p <0.0001; Hazard Ratio (HR) 0.24 NCT04811092 ↗

paper the addition of sotatercept to background therapy resulted in a lower risk of clinical worsening than placebo. PMID 41025556 ↗

release “第3相HYPERION試験の良好な結果を発表しました。この試験で、WINREVAIR™は臨床的悪化イベントのリスクを76%低下させました” msd.co.jp ↗

Publications

McLaughlin VV, Hoeper MM, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, Preston IR, Souza R, Waxman AB, Kopec G, Meyer G, Olsson KM, Fu W, Shi Y, Miller B, Kim SS, Mackenzie HS, Brambatti M, Patel MJ, Koglin J, Cornell AG, Humbert M; HYPERION Trial Investigators. Sotatercept for Pulmonary Arterial Hypertension within the First Year after Diagnosis. N Engl J Med. 2025 Oct 23;393(16):1599-1611. doi: 10.1056/NEJMoa2508170. Epub 2025 Sep 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sotatercept	Protein / enzyme biologic	0.7 mg/kg	Subcutaneous