Status:
COMPLETED
A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)
Lead Sponsor:
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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) v...
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 tra...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2025
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT04896008
Start Date
December 1 2021
End Date
February 18 2025
Last Update
August 22 2025
Active Locations (57)
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1
Arizona Pulmonary Specialists ( Site 1010)
Phoenix, Arizona, United States, 85013
2
David Geffen School of Medicine at UCLA ( Site 1068)
Los Angeles, California, United States, 90095
3
University of California Irvine ( Site 1086)
Orange, California, United States, 92868-2994
4
University of California San Diego Medical Center ( Site 1002)
San Diego, California, United States, 92037