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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT04896008

Run by

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

People needed

173

Starts

2021-12-01

Expected to finish

2025-02-18

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnostic right heart catheterization prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes:
• Idiopathic PAH
• Heritable PAH
• Drug/toxin-induced PAH
• PAH associated with CTD
• PAH associated with simple, congenital systemic to pulmonary shunts at least 1 year following repair
• Symptomatic PAH classified as WHO FC III or IV
• REVEAL Lite 2.0 risk score of ≥9
• Right heart catheterization performed during screening (or within 2 weeks prior to screening, if done at the clinical study site) documenting a minimum PVR of ≥5 Wood units and a pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤15 mmHg
• Clinically stable and on stable doses of maximum tolerated (per investigator's judgment) double or triple background PAH therapies for at least 30 days prior to screening
• Females of childbearing potential must:
• Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy; must agree to ongoing urine or serum pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug
• If sexually active with a male partner, have used, and agree to use highly effective contraception without interruption per protocol; for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment
• Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study treatment
• Male participants must:
• Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
• Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment
• Ability to adhere to study visit schedule and understand and comply with all protocol requirements
• Ability to understand and provide written informed consent

You may not qualify if…

• Diagnosis of pulmonary hypertension (PH) WHO Groups 2, 3, 4, or 5
• Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus-associated PAH and PAH associated with portal hypertension
• Diagnosis of pulmonary veno-occlusive diseases or pulmonary capillary hemangiomatosis or overt signs of capillary and/or venous involvement
• Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local laboratory test
• Baseline platelet count <50,000/mm3 (<50.0 x 109/L) at screening
• Baseline systolic blood pressure <85 mmHg at screening
• Pregnant or breastfeeding women
• Serum alanine aminotransferase or aspartate aminotransferase levels or total bilirubin >3.0×ULN
• Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent
• Prior exposure to sotatercept or known allergic reaction to sotatercept, its excipients or luspatercept
• History of pneumonectomy
• Untreated more than mild obstructive sleep apnea
• History of known pericardial constriction
• History of restrictive or congestive cardiomyopathy
• Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) >500 ms during the screening period
• Personal or family history of long QT syndrome or sudden cardiac death
• Left ventricular ejection fraction <45% on historical echocardiogram within 1 year prior to the screening visit
• Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) in the past 6 months prior to the screening visit
• Cerebrovascular accident within 3 months prior to the screening visit
• Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
• Currently on dialysis or anticipated need for dialysis within the next 12 months

Where it is running

• David Geffen School of Medicine at UCLA ( Site 1068) — Los Angeles, California, United States
• University of California Irvine ( Site 1086) — Orange, California, United States
• University of California San Diego Medical Center ( Site 1002) — San Diego, California, United States
• University of California San Francisco ( Site 1019) — San Francisco, California, United States
• University of Colorado Hospital ( Site 1013) — Aurora, Colorado, United States
• The George Washington University Medical Faculty Associates ( Site 1025) — Washington D.C., District of Columbia, United States
• Mayo Clinic Jacksonville - PPDS ( Site 1045) — Jacksonville, Florida, United States
• AdventHealth Medical Group Advanced Lung Disease ( Site 1058) — Orlando, Florida, United States
• Northside Hospital ( Site 1073) — Atlanta, Georgia, United States
• University Of Iowa Hospitals and Clinics ( Site 1050) — Iowa City, Iowa, United States
• University of Kansas Medical Center ( Site 1020) — Kansas City, Kansas, United States
• Tufts Medical Center - PPDS ( Site 1012) — Boston, Massachusetts, United States
• Brigham and Women's Hospital ( Site 1014) — Boston, Massachusetts, United States
• University of Michigan ( Site 1011) — Ann Arbor, Michigan, United States
• Washington University School of Medicine ( Site 1022) — St Louis, Missouri, United States
• University of Nebraska Medical Center ( Site 1053) — Omaha, Nebraska, United States
• University of New Mexico Health Sciences Center ( Site 1048) — Albuquerque, New Mexico, United States
• University of Rochester Medical Center - PPDS ( Site 1039) — Rochester, New York, United States
• Duke University Medical Center ( Site 1026) — Durham, North Carolina, United States
• University of Cincinnati Medical Center ( Site 1035) — Cincinnati, Ohio, United States
• The Cleveland Clinic Foundation. ( Site 1065) — Cleveland, Ohio, United States
• Medical University of South Carolina - PPDS ( Site 1003) — Charleston, South Carolina, United States
• Statcare Pulmonary Consultants - Knoxville ( Site 1031) — Knoxville, Tennessee, United States
• University Of Texas Southwestern Medical Center ( Site 1038) — Dallas, Texas, United States
• Arizona Pulmonary Specialists ( Site 1010) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.