A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)
Public ClinicalTrials.gov record NCT04896008. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04896008
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Industry
- Enrollment
- 173 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 1, 2021 (Actual)
- Primary completion
- Jul 26, 2024 (Actual)
- Completion
- Feb 18, 2025 (Actual)
- Last update posted
- May 29, 2026
2021 – 2025
United States locations
- U.S. sites
- 26
- U.S. states
- 20
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Pulmonary Specialists ( Site 1010) | Phoenix | Arizona | 85013 | — |
| David Geffen School of Medicine at UCLA ( Site 1068) | Los Angeles | California | 90095 | — |
| University of California Irvine ( Site 1086) | Orange | California | 92868-2994 | — |
| University of California San Diego Medical Center ( Site 1002) | San Diego | California | 92037 | — |
| University of California San Francisco ( Site 1019) | San Francisco | California | 94118 | — |
| University of Colorado Hospital ( Site 1013) | Aurora | Colorado | 80045 | — |
| The George Washington University Medical Faculty Associates ( Site 1025) | Washington D.C. | District of Columbia | 20037 | — |
| Mayo Clinic Jacksonville - PPDS ( Site 1045) | Jacksonville | Florida | 32224 | — |
| AdventHealth Medical Group Advanced Lung Disease ( Site 1058) | Orlando | Florida | 32804 | — |
| Northside Hospital ( Site 1073) | Atlanta | Georgia | 30342 | — |
| University Of Iowa Hospitals and Clinics ( Site 1050) | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center ( Site 1020) | Kansas City | Kansas | 66160 | — |
| Tufts Medical Center - PPDS ( Site 1012) | Boston | Massachusetts | 02111 | — |
| Brigham and Women's Hospital ( Site 1014) | Boston | Massachusetts | 02115 | — |
| University of Michigan ( Site 1011) | Ann Arbor | Michigan | 48109 | — |
| Washington University School of Medicine ( Site 1022) | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center ( Site 1053) | Omaha | Nebraska | 68105 | — |
| University of New Mexico Health Sciences Center ( Site 1048) | Albuquerque | New Mexico | 87131 | — |
| University of Rochester Medical Center - PPDS ( Site 1039) | Rochester | New York | 14642-0001 | — |
| Duke University Medical Center ( Site 1026) | Durham | North Carolina | 27713 | — |
| University of Cincinnati Medical Center ( Site 1035) | Cincinnati | Ohio | 45267-0558 | — |
| The Cleveland Clinic Foundation. ( Site 1065) | Cleveland | Ohio | 44103-3736 | — |
| Medical University of South Carolina - PPDS ( Site 1003) | Charleston | South Carolina | 29425 | — |
| Statcare Pulmonary Consultants - Knoxville ( Site 1031) | Knoxville | Tennessee | 37909 | — |
| University Of Texas Southwestern Medical Center ( Site 1038) | Dallas | Texas | 75390 | — |
| Medical College of Wisconsin - Froedtert Hospital ( Site 1051) | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04896008, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 29, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04896008 live on ClinicalTrials.gov.