A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)
NCT ID: NCT04945460
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
164 participants
INTERVENTIONAL
2021-12-29
2026-03-30
Brief Summary
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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).
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Detailed Description
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As of protocol amendment 6, the 18-month Extension Period is being removed. Participants who have completed at least the 24-week placebo controlled treatment period and the end of study visit, and who have not discontinued study treatment early, may be eligible to participate in an extension study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Arm 1: Treatment Group 1: Placebo delivered subcutaneously (SC) every 3 weeks (Q3W) for 24 weeks
Arm 2: Treatment Group 2: Sotatercept SC at a dose level of 0.3 mg/kg Q3W for 24 weeks
Arm 3: Treatment Group 3: Sotatercept SC at a starting dose level of 0.3 mg/kg for 3 dosing visits (Q3W), then escalating to 0.7 mg/kg SC on the fourth dosing visit and Q3W for the remainder of the 24-week Treatment Period
TREATMENT
TRIPLE
Study Groups
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Placebo
Delivered subcutaneously (SC) every 3 weeks (Q3W) for 24 weeks in the placebo-controlled treatment period.
Placebo
Administered by subcutaneous injection
Sotatercept 0.3 mg/kg
Participants will receive sotatercept SC at a dose level of 0.3 mg/kg Q3W for 24 weeks in the placebo-controlled treatment period.
Sotatercept 0.3 mg/kg
Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.
Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kg
Sotatercept SC at a starting dose level of 0.3 mg/kg for 3 dosing visits (Q3W), then escalating to 0.7 mg/kg SC on the fourth dosing visit and Q3W for the remainder of the 24-week treatment Period.
Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg
Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.
Interventions
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Sotatercept 0.3 mg/kg
Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.
Placebo
Administered by subcutaneous injection
Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg
Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Age 18 to 85 years
2. 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
3. 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
4. New York Heart Association FC of II or III
5. Six-minute Walk Distance ≥100 m repeated twice during Screening and both values within 15% of each other, calculated from the highest value
6. 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.
7. 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
8. 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
9. Ability to adhere to the study visit schedule and understand and comply with all protocol requirements
10. Agreement to not participate in any other trials of investigational drugs/devices while enrolled in the A011-16 study
11. Ability to understand and provide documented consent for participation
Exclusion Criteria
1. A diagnosis of PH in WHO Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
2. 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)
3. 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
* Personal or family history of long QT syndrome unless the participant's ECG shows a normal QTc
* Arrhythmogenic right ventricular dysplasia (ARVD) unless the participant has a recent cardiac MRI that shows no evidence of this diagnosis
4. Hospitalization for any worsening of medical conditions or any significant surgery per investigator within 30 days of Visit 1.
5. Received any approved PAH-specific therapies (i.e., endothelin receptor antagonists, prostacyclin analogs, phosphodiesterase-5 inhibitors, soluble guanylate cyclase stimulators) within 30 days of Visit 1.The use of an oral phosphodiesterase type 5 inhibitor, if only indicated for erectile dysfunction, is permitted, if not administered within 48 hours of a study visit or procedure.
6. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin,or levosimendan) within 30 days of Visit 1
7. Received erythropoietin within 6 months of Visit 1.
8. Known history of chronic liver disease, including untreated hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), with severe hepatic impairment and/or cirrhosis (e.g., hepatic encephalopathy)
9. Prior exposure to sotatercept or luspatercept.
10. Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for investigational biologics prior to the date of documented consent.
11. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days of Visit 1 or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).
12. Any of the following clinical laboratory values prior to Visit 1 as specified:
* Hemoglobin (Hgb) above the gender-specific upper limit of normal (ULN) per local laboratory test within 28 days of Visit 1or \<10 g/dL per local laboratory within 28 days of Visit 1
* Serum alanine aminotransferase or aspartate aminotransferase levels \>3× ULN or total bilirubin \>3× ULN within 28 days of Visit 1
* Estimated glomerular filtration rate \<30 ml/min/1.73 m2 (4-variable Modification of Diet in Renal Disease equation) within 28 days of Visit 1 or required renal replacement therapy within 90 days of Visit 1
* Glycated hemoglobin (HbA1c) \>10% within 28 days of Visit 1
* Platelet count \< 75,000/mm3 within 28 days of Visit 1
13. History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in the investigational product .
14. Major surgery within 60 days of Visit 1. Participants must have completely recovered from any previous surgery prior to Visit 1.
15. Prior organ transplantation (e.g., heart, lung, liver, kidney), bone marrow transplantation, or life expectancy of \< 12 months.
16. Pregnancy or breastfeeding in females.
17. Active malignancy, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in situ, or ≤ 2 squamous cell carcinomas of the skin.
18. History of clinically significant (as determined by the investigator) endocrine, hematologic, hepatic, (auto)immune, infectious (requiring chronic antibiotics), metabolic, urologic, pulmonary, neurologic, neuromuscular, dermatologic, psychiatric, renal, and/or another disease that may limit participation in the study.
19. Body mass index ≥50 kg/m2.
20. More than mild obstructive sleep apnea (treated or untreated).
21. Any non-cardiopulmonary condition or acute/chronic impairment(s) (other than dyspnea) that limits the ability to perform 6-minute walk test (6MWT).
18 Years
85 Years
ALL
No
Sponsors
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Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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PULMONARY ASSOCIATES, P.A. ( Site 1008)
Phoenix, Arizona, United States
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
University of Louisville ( Site 1099)
Louisville, Kentucky, United States
University Medical Center New Orleans ( Site 1057)
New Orleans, Louisiana, United States
Tufts Medical Center - PPDS ( Site 1012)
Boston, Massachusetts, United States
Brigham and Women's Hospital [Boston, MA] ( Site 1014)
Boston, Massachusetts, United States
University of Michigan ( Site 1011)
Ann Arbor, Michigan, United States
University of Minnesota Hospitals ( Site 1062)
Minneapolis, Minnesota, United States
Washington University School of Medicine [Saint Louis, MO] ( Site 1022)
St Louis, Missouri, United States
University of Nebraska Medical Center ( Site 1053)
Omaha, Nebraska, United States
Pulmonary Health Physicians ( Site 1080)
Liverpool, New York, United States
Weill Cornell Medical College ( Site 1046)
New York, New York, 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
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center ( Site 1005)
Cleveland, Ohio, United States
Cleveland Clinic Foundation ( Site 1065)
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center ( Site 1032)
Columbus, Ohio, United States
University of Toledo Medical Center ( Site 1070)
Toledo, Ohio, United States
Oregon Health Science University ( Site 1054)
Portland, Oregon, United States
Allegheny General Hospital ( Site 1088)
Pittsburgh, Pennsylvania, United States
Lankenau Institute for Medical Research ( Site 1089)
Wynnewood, Pennsylvania, United States
Rhode Island Hospital ( Site 1033)
Providence, Rhode Island, 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
Baylor University Medical Center ( Site 1096)
Dallas, Texas, United States
University of Texas Southwestern Medical Center ( Site 4002)
Dallas, Texas, United States
Intermountain Medical Center ( Site 1079)
Murray, Utah, United States
Inova Heart and Vascular Institute ( Site 1078)
Falls Church, Virginia, United States
Bon Secours St. Mary's Hospital ( Site 1069)
Richmond, Virginia, United States
West Virginia University ( Site 1081)
Morgantown, West Virginia, United States
Aurora St Luke's Medical Center ( Site 1083)
Milwaukee, Wisconsin, United States
Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)
Milwaukee, Wisconsin, United States
Hôpital Erasme ( Site 1402)
Anderlecht, Bruxelles-Capitale, Region de, Belgium
UZ Leuven - Campus Gasthuisberg ( Site 1401)
Leuven, Vlaams-Brabant, Belgium
University Of Alberta ( Site 2101)
Edmonton, Alberta, Canada
Hamilton General Hospital-Special Immunology Services Clinic ( Site 2110)
Hamilton, Ontario, Canada
University Health Network ( Site 2109)
Toronto, Ontario, Canada
Institut Universitaire de Cardiologie et de Pneumologie ( Site 2107)
Sainte-Foy, Quebec, Canada
Hôpital Pasteur - CHU Nice ( Site 1311)
Nice, Alpes-Maritimes, France
Centre Hospitalier Universitaire du Besancon ( Site 1324)
Besançon, Doubs, France
Hopital de Rangueil du Toulouse ( Site 1322)
Toulouse, Haute-Garonne, France
CHU Montpellier Hôpital Arnaud de VIlleneuve ( Site 1301)
Montpellier, Herault, France
Hôpital Pontchaillou ( Site 1319)
Rennes, Ille-et-Vilaine, France
Centre Hospitalier Universitaire de Grenoble ( Site 1303)
Grenoble, Isere, France
CHU de Nantes - Hoptal Nord Laennec ( Site 1309)
Nantes, Loire-Atlantique, France
CHU Angers ( Site 1313)
Angers, Maine-et-Loire, France
CHRU de Nancy Hopitaux de Brabois ( Site 1308)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHRU Lille ( Site 1306)
Lille, Nord, France
CHU de Rouen ( Site 1323)
Rouen, Seine-Maritime, France
Centre Hospitalier Universitaire de Bicetre ( Site 1304)
Le Kremlin-Bicêtre, Val-de-Marne, France
Thoraxklinik-Heidelberg gGmbH ( Site 1509)
Heidelberg, Baden-Wurttemberg, Germany
Krankenhaus Neuwittelsbach ( Site 1510)
München, Bavaria, Germany
University Hospital Regensburg ( Site 1503)
Regensburg, Bavaria, Germany
Kerckhoff-Klinik-Forschungs-GmbH ( Site 1514)
Bad Nauheim, Hesse, Germany
Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)
Giessen, Hesse, Germany
Medizinische Hochschule Hannover ( Site 1505)
Hanover, Lower Saxony, Germany
Uniklinik Köln ( Site 1511)
Cologne, North Rhine-Westphalia, Germany
Universitaetsmedizin Johannes Gutenberg Universitaet Mainz ( Site 1515)
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden. ( Site 1501)
Dresden, Saxony, Germany
DRK Kliniken Berlin Westend ( Site 1507)
Berlin, , Germany
Assuta Ashdod Medical Center ( Site 1710)
Ashdod, , Israel
Shamir Medical Center Assaf Harofeh ( Site 1713)
Be’er Ya‘aqov, , Israel
Rambam Health Corp. ( Site 1716)
Haifa, , Israel
Lady Davis Carmel Medical Center ( Site 1705)
Haifa, , Israel
Edith Wolfson Medical Center ( Site 1717)
Holon, , Israel
Shaare Zedek Medical Center ( Site 1715)
Jerusalem, , Israel
Hadassah Ein Kerem Medical Center ( Site 1711)
Jerusalem, , Israel
Meir Medical Center. ( Site 1707)
Kfar Saba, , Israel
Rabin Medical Center ( Site 1703)
Petah Tikva, , Israel
Kaplan Medical Center ( Site 1712)
Rehovot, , Israel
ZIV Medical Center ( Site 1704)
Safed, , Israel
Tel Aviv Sourasky Medical Center ( Site 1714)
Tel Aviv, , Israel
AOU di Bologna Policlinico S Orsola Malpighi ( Site 2409)
Bologna, Emilia-Romagna, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)
Trieste, Friuli Venezia Giulia, Italy
Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406)
Monza, Lombardy, Italy
Fondazione IRCCS-Policlinico San Matteo ( Site 2401)
Pavia, Lombardy, Italy
Ospedale SS Annunziata ( Site 2408)
Sassari, Sardinia, Italy
ASST Papa Giovanni XXIII ( Site 2410)
Bergamo, , Italy
Azienda Policlinico Umberto I ( Site 2402)
Roma, , Italy
Unidad de Investigacion Clinica En Medicina SC ( Site 2505)
Monterrey, Nuevo León, Mexico
Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2801)
Krakow, Lesser Poland Voivodeship, Poland
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 2806)
Lubin, Lublin Voivodeship, Poland
Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)
Otwock, Masovian Voivodeship, Poland
Państwowy Instytut Medyczny MSWiA ( Site 2805)
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 2803)
Bialystok, Podlaskie Voivodeship, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie ( Site 2804)
Szczecin, West Pomeranian Voivodeship, Poland
Wojewodzki Specjalistyczny Szpital im dr WI Bieganskiego w Lodzi ( Site 2807)
Lodz, Łódź Voivodeship, Poland
Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604)
Majadahonda, Madrid, Spain
Hospital Costa del Sol ( Site 1613)
Marbella, Malaga, Spain
Hospital Clinic de Barcelona ( Site 1602)
Barcelona, , Spain
Hospital Universitario 12 de Octubre ( Site 1603)
Madrid, , Spain
Hospital Universitario Virgen Macarena ( Site 1612)
Seville, , Spain
Hospital Universitario de Toledo ( Site 1607)
Toledo, , Spain
Sahlgrenska Universitetssjukhuset ( Site 3201)
Gothenburg, Västra Götaland County, Sweden
Imperial College Healthcare NHS Trust ( Site 1203)
London, London, City of, United Kingdom
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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A011-16
Identifier Type: OTHER
Identifier Source: secondary_id
MK-7962-007
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509141-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1309-6433
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-003020-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7962-007
Identifier Type: -
Identifier Source: org_study_id
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