A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertension, Pulmonary

In brief

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

Key facts

Study ID

NCT04945460

Run by

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

People needed

164

Starts

2021-12-29

Expected to finish

2026-04-09

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet the following criteria to be enrolled in this proof-of-concept study:
• Age 18 to 85 years
• Clinical diagnosis of HFpEF:
• Left ventricular ejection fraction ≥50%, with no history of LVEF below 45% in more than two consecutive measurements under stable conditions
• Demonstrated Cpc-PH by all of the following:
• Baseline RHC performed within 28 days of randomization documenting a minimum PVR of ≥320 dyn•sec/cm5 (4 wood units)
• Mean pulmonary arterial pressure (mPAP) of >20 mmHg
• Pulmonary capillary wedge pressure (PCWP) >15 mmHg but < 30 mmHg
• New York Heart Association FC of II or III
• Six-minute Walk Distance ≥100 m repeated twice during Screening and both values within 15% of each other, calculated from the highest value
• Chronic medication for HF or for any underlying condition, administered at a stable (per investigator) dose for ≥30 days prior to Visit 1. Diuretics and/or anticoagulants are excepted from this rule but should not be newly started or stopped within 30 days of Visit 1, and a prescribed dose change should not occur within 7 days of Visit 1. Anticoagulation may be suspended for RHC if necessary
• Women of childbearing potential must:
• Have 2 negative urine or serum pregnancy tests as verified by the investigator during the Screening Period; must agree to ongoing 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: use highly effective contraception without interruption for at least 28 days prior to starting the investigational product AND agree to use the same highly effective contraception in combination with a barrier method 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 drug
• Male participants must:
• Agree to use a condom, defined as a male latex condom or non latex 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 drug
• Ability to adhere to the study visit schedule and understand and comply with all protocol requirements
• Agreement to not participate in any other trials of investigational drugs/devices while enrolled in the A011-16 study
• Ability to understand and provide documented consent for participation

You may not qualify if…

• Participants will be excluded from the study if any of the following criteria are met:
• A diagnosis of PH in WHO Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
• Clinically significant and active lung disease:
• Chronic obstructive pulmonary disease with post-bronchodilator forced expiratory volume in the first second (FEV1) <60% predicted
• Restrictive lung disease with total lung capacity <70% predicted
• More than mild interstitial lung disease (ILD), with FVC<70% or FEV1<60% predicted (still appropriate if absence of more than mild ILD, fibrosis, or COPD on computed tomography [CT] imaging)
• Cardiovascular co-morbidities, which include any of the following:
• History of more than mild mitral or aortic stenosis
• Ongoing more than mild mitral or aortic regurgitation
• More than one valve replacement or repair (mechanical or biomechanical) or anticipation of any valve replacement or repair
• Severe tricuspid regurgitation due to primary valvular disease
• Occurrence of myocardial infarction, acute coronary syndrome, coronary artery bypass graft or percutaneous coronary intervention within 180 days of Visit 1
• History of serious life-threatening or hemodynamically significant arrhythmia
• History of or anticipated heart transplant or ventricular assist device implantation
• History of implantable cardioverter defibrillator placement or anticipated implantation of pacemaker, pacemaker implantation within 30 days of Screening
• Anticipated implantation of pacemaker, pacemaker implantation within 30 days of Screening or history of implantable cardioverter defibrillator placement
• Occurrence of myocardial infarction within 180 days of Visit 1
• History of known pericardial constriction, hypertrophic cardiomyopathy, sarcoidosis, or amyloid cardiomyopathy
• Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mmHg or sitting diastolic blood pressure >110 mmHg during Screening after a period of rest
• Systemic hypotension as evidenced by sitting systolic blood pressure <90 mmHg or sitting diastolic blood pressure <50 mmHg during Screening
• Resting heart rate of <45 bpm or >115 bpm
• Stroke within 90 days of Visit 1
• Acutely decompensated HF that required hospitalization within 30 days of Visit 1
• Electrocardiogram during Screening Period with Fridericia's corrected QT interval (QTcF) >470 msec for males or >480 msec for females, or >500 msec if a ventricular conduction defect (right bundle branch block; left bundle branch block; or interventricular conduction delay) is present
• Personal or family history of Brugada syndrome, sudden cardiac arrest or unexplained sudden cardiac death or arrest

Where it is running

• University of Arizona ( Site 1006) — Tucson, Arizona, United States
• Scripps Clinic ( Site 4001) — La Jolla, California, United States
• Cedars Sinai Medical Center ( Site 1082) — Los Angeles, California, United States
• University of California Irvine ( Site 1086) — Orange, California, United States
• Jeffrey S.Sager MD Medical Corporation ( Site 1060) — Santa Barbara, California, United States
• Stanford University ( Site 1024) — Stanford, California, United States
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028) — Torrance, California, United States
• University Of Colorado ( Site 1013) — Aurora, Colorado, United States
• South Denver Cardiology Associates ( Site 1091) — Littleton, Colorado, United States
• Winchester Chest Clinic ( Site 1093) — New Haven, Connecticut, United States
• The George Washington University Medical Faculty Associates ( Site 1025) — Washington D.C., District of Columbia, United States
• Bay Area Cardiology ( Site 1071) — Brandon, Florida, United States
• Mayo Clinic Jacksonville - PPDS ( Site 1045) — Jacksonville, Florida, United States
• AdventHealth Orlando ( Site 1058) — Orlando, Florida, United States
• Tampa General Hospital ( Site 1043) — Tampa, Florida, United States
• Piedmont Atlanta Hospital ( Site 1085) — Atlanta, Georgia, United States
• Emory University ( Site 1030) — Atlanta, Georgia, United States
• Saint Alphonsus Regional Medical Center ( Site 1097) — Boise, Idaho, United States
• University of Illinois Hospital ( Site 1095) — Chicago, Illinois, United States
• IU Health Advanced Heart and Lung Care ( Site 1092) — Indianapolis, Indiana, United States
• Ascension Medical Group St. Vincent ( Site 1076) — Indianapolis, Indiana, United States
• University of Iowa Hospital and Clinics ( Site 1050) — Iowa City, Iowa, United States
• University of Kansas Medical Center ( Site 1020) — Kansas City, Kansas, United States
• Norton Pulmonary Specialists ( Site 1066) — Louisville, Kentucky, United States
• PULMONARY ASSOCIATES, P.A. ( Site 1008) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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