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New drug shows promise for Hard-to-Treat lung condition in heart failure

NCT ID NCT04945460

Disease control Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tested a drug called sotatercept in 164 adults with a type of high blood pressure in the lungs caused by heart failure. The study compared sotatercept to a placebo to see if it could improve blood flow and walking distance. The goal is to find a better treatment for this serious condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sotatercept
What this could lead to
If successful, this could point toward a new treatment option for people with a specific type of pulmonary hypertension linked to heart failure.
What could go wrong
This is an early Phase 2 trial with only 164 participants, so results may not apply to everyone. The drug may not improve symptoms or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

164 people

The number who actually took part.

Started

Dec 2021

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants must meet the following criteria to be enrolled in this proof-of-concept study: 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: Participants will be excluded from the study if any of the following criteria are met: 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)

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Conditions

The condition(s) this trial relates to.

hypertensive disorder pulmonary hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension, pulmonary

Contacts and locations

Locations

  • AOU di Bologna Policlinico S Orsola Malpighi ( Site 2409)

    Bologna, Emilia-Romagna, 40138, Italy

  • ASST Papa Giovanni XXIII ( Site 2410)

    Bergamo, 24127, Italy

  • AdventHealth Orlando ( Site 1058)

    Orlando, Florida, 32803, United States

  • Allegheny General Hospital ( Site 1088)

    Pittsburgh, Pennsylvania, 15212-4737, United States

  • Ascension Medical Group St. Vincent ( Site 1076)

    Indianapolis, Indiana, 46260, United States

  • Assuta Ashdod Medical Center ( Site 1710)

    Ashdod, 7747629, Israel

  • Aurora St Luke's Medical Center ( Site 1083)

    Milwaukee, Wisconsin, 53215, United States

  • Azienda Policlinico Umberto I ( Site 2402)

    Roma, 00161, Italy

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)

    Trieste, Friuli Venezia Giulia, 34149, Italy

  • Bay Area Cardiology ( Site 1071)

    Brandon, Florida, 33511, United States

  • Baylor University Medical Center ( Site 1096)

    Dallas, Texas, 75246, United States

  • Bon Secours St. Mary's Hospital ( Site 1069)

    Richmond, Virginia, 23226, United States

  • Brigham and Women's Hospital [Boston, MA] ( Site 1014)

    Boston, Massachusetts, 02115, United States

  • CHRU Lille ( Site 1306)

    Lille, Nord, 59037, France

  • CHRU de Nancy Hopitaux de Brabois ( Site 1308)

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

  • CHU Angers ( Site 1313)

    Angers, Maine-et-Loire, 49933, France

  • CHU Montpellier Hôpital Arnaud de VIlleneuve ( Site 1301)

    Montpellier, Herault, 34090, France

  • CHU de Nantes - Hoptal Nord Laennec ( Site 1309)

    Nantes, Loire-Atlantique, 44000, France

  • CHU de Rouen ( Site 1323)

    Rouen, Seine-Maritime, 76000, France

  • Cedars Sinai Medical Center ( Site 1082)

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Universitaire de Bicetre ( Site 1304)

    Le Kremlin-Bicêtre, Val-de-Marne, 94270, France

  • Centre Hospitalier Universitaire de Grenoble ( Site 1303)

    Grenoble, Isere, 38043, France

  • Centre Hospitalier Universitaire du Besancon ( Site 1324)

    Besançon, Doubs, 25000, France

  • Cleveland Clinic Foundation ( Site 1065)

    Cleveland, Ohio, 44195, United States

  • DRK Kliniken Berlin Westend ( Site 1507)

    Berlin, 14050, Germany

  • Duke University Medical Center ( Site 1026)

    Durham, North Carolina, 27710-4000, United States

  • Edith Wolfson Medical Center ( Site 1717)

    Holon, 5810001, Israel

  • Emory University ( Site 1030)

    Atlanta, Georgia, 30322-1013, United States

  • Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)

    Otwock, Masovian Voivodeship, 05-400, Poland

  • Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406)

    Monza, Lombardy, 20900, Italy

  • Fondazione IRCCS-Policlinico San Matteo ( Site 2401)

    Pavia, Lombardy, 27100, Italy

  • Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)

    Milwaukee, Wisconsin, 53226, United States

  • Hadassah Ein Kerem Medical Center ( Site 1711)

    Jerusalem, 91120, Israel

  • Hamilton General Hospital-Special Immunology Services Clinic ( Site 2110)

    Hamilton, Ontario, L8L 2X2, Canada

  • Hopital de Rangueil du Toulouse ( Site 1322)

    Toulouse, Haute-Garonne, 31400, France

  • Hospital Clinic de Barcelona ( Site 1602)

    Barcelona, 08036, Spain

  • Hospital Costa del Sol ( Site 1613)

    Marbella, Malaga, 29603, Spain

  • Hospital Universitario 12 de Octubre ( Site 1603)

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604)

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Virgen Macarena ( Site 1612)

    Seville, 41009, Spain

  • Hospital Universitario de Toledo ( Site 1607)

    Toledo, 41007, Spain

  • Hôpital Erasme ( Site 1402)

    Anderlecht, Bruxelles-Capitale, Region de, 1070, Belgium

  • Hôpital Pasteur - CHU Nice ( Site 1311)

    Nice, Alpes-Maritimes, 06000, France

  • Hôpital Pontchaillou ( Site 1319)

    Rennes, Ille-et-Vilaine, 35033, France

  • IU Health Advanced Heart and Lung Care ( Site 1092)

    Indianapolis, Indiana, 46202-1218, United States

  • Imperial College Healthcare NHS Trust ( Site 1203)

    London, London, City of, W12 0HS, United Kingdom

  • Inova Heart and Vascular Institute ( Site 1078)

    Falls Church, Virginia, 22042, United States

  • Institut Universitaire de Cardiologie et de Pneumologie ( Site 2107)

    Sainte-Foy, Quebec, G1V 4G5, Canada

  • Intermountain Medical Center ( Site 1079)

    Murray, Utah, 84107, United States

  • Jeffrey S.Sager MD Medical Corporation ( Site 1060)

    Santa Barbara, California, 93105-5311, United States

  • Kaplan Medical Center ( Site 1712)

    Rehovot, 7610001, Israel

  • Kerckhoff-Klinik-Forschungs-GmbH ( Site 1514)

    Bad Nauheim, Hesse, 61231, Germany

  • Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2801)

    Krakow, Lesser Poland Voivodeship, 31-202, Poland

  • Krankenhaus Neuwittelsbach ( Site 1510)

    München, Bavaria, 80639, Germany

  • Lady Davis Carmel Medical Center ( Site 1705)

    Haifa, 3436212, Israel

  • Lankenau Institute for Medical Research ( Site 1089)

    Wynnewood, Pennsylvania, 19096, United States

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)

    Torrance, California, 90502, United States

  • Mayo Clinic Jacksonville - PPDS ( Site 1045)

    Jacksonville, Florida, 32224, United States

  • Medical University of South Carolina - PPDS ( Site 1003)

    Charleston, South Carolina, 29425-0001, United States

  • Medizinische Hochschule Hannover ( Site 1505)

    Hanover, Lower Saxony, 30625, Germany

  • Meir Medical Center. ( Site 1707)

    Kfar Saba, 4428164, Israel

  • Norton Pulmonary Specialists ( Site 1066)

    Louisville, Kentucky, 40202, United States

  • Oregon Health Science University ( Site 1054)

    Portland, Oregon, 97126, United States

  • Ospedale SS Annunziata ( Site 2408)

    Sassari, Sardinia, 07100, Italy

  • PULMONARY ASSOCIATES, P.A. ( Site 1008)

    Phoenix, Arizona, 85032, United States

  • Państwowy Instytut Medyczny MSWiA ( Site 2805)

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Piedmont Atlanta Hospital ( Site 1085)

    Atlanta, Georgia, 30309-1281, United States

  • Pulmonary Health Physicians ( Site 1080)

    Liverpool, New York, 13088, United States

  • Rabin Medical Center ( Site 1703)

    Petah Tikva, 4941492, Israel

  • Rambam Health Corp. ( Site 1716)

    Haifa, 3109601, Israel

  • Rhode Island Hospital ( Site 1033)

    Providence, Rhode Island, 02903, United States

  • Sahlgrenska Universitetssjukhuset ( Site 3201)

    Gothenburg, Västra Götaland County, 413 45, Sweden

  • Saint Alphonsus Regional Medical Center ( Site 1097)

    Boise, Idaho, 83704-8880, United States

  • Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie ( Site 2804)

    Szczecin, West Pomeranian Voivodeship, 70-111, Poland

  • Scripps Clinic ( Site 4001)

    La Jolla, California, 92037-1205, United States

  • Shaare Zedek Medical Center ( Site 1715)

    Jerusalem, 91031, Israel

  • Shamir Medical Center Assaf Harofeh ( Site 1713)

    Be’er Ya‘aqov, 70300, Israel

  • South Denver Cardiology Associates ( Site 1091)

    Littleton, Colorado, 80120, United States

  • Stanford University ( Site 1024)

    Stanford, California, 94305, United States

  • Statcare Pulmonary Consultants - Knoxville ( Site 1031)

    Knoxville, Tennessee, 37919, United States

  • Tampa General Hospital ( Site 1043)

    Tampa, Florida, 33606, United States

  • Tel Aviv Sourasky Medical Center ( Site 1714)

    Tel Aviv, 64239, Israel

  • The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)

    Cincinnati, Ohio, 45219, United States

  • The George Washington University Medical Faculty Associates ( Site 1025)

    Washington D.C., District of Columbia, 20037-3201, United States

  • The Ohio State University Wexner Medical Center ( Site 1032)

    Columbus, Ohio, 43210, United States

  • Thoraxklinik-Heidelberg gGmbH ( Site 1509)

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • Tufts Medical Center - PPDS ( Site 1012)

    Boston, Massachusetts, 02111, United States

  • UZ Leuven - Campus Gasthuisberg ( Site 1401)

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Unidad de Investigacion Clinica En Medicina SC ( Site 2505)

    Monterrey, Nuevo León, 64710, Mexico

  • Uniklinik Köln ( Site 1511)

    Cologne, North Rhine-Westphalia, 50931, Germany

  • Universitaetsmedizin Johannes Gutenberg Universitaet Mainz ( Site 1515)

    Mainz, Rhineland-Palatinate, 55131, Germany

  • University Health Network ( Site 2109)

    Toronto, Ontario, M5G 2N2, Canada

  • University Hospital Regensburg ( Site 1503)

    Regensburg, Bavaria, 93053, Germany

  • University Hospitals Cleveland Medical Center ( Site 1005)

    Cleveland, Ohio, 44106, United States

  • University Medical Center New Orleans ( Site 1057)

    New Orleans, Louisiana, 70112, United States

  • University Of Alberta ( Site 2101)

    Edmonton, Alberta, T6G 2B7, Canada

  • University Of Colorado ( Site 1013)

    Aurora, Colorado, 80045, United States

  • University of Arizona ( Site 1006)

    Tucson, Arizona, 85724-0001, United States

  • University of California Irvine ( Site 1086)

    Orange, California, 92868, United States

  • University of Illinois Hospital ( Site 1095)

    Chicago, Illinois, 60612, United States

  • University of Iowa Hospital and Clinics ( Site 1050)

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center ( Site 1020)

    Kansas City, Kansas, 66160, United States

  • University of Louisville ( Site 1099)

    Louisville, Kentucky, 40202, United States

  • University of Michigan ( Site 1011)

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota Hospitals ( Site 1062)

    Minneapolis, Minnesota, 55455, United States

  • University of Nebraska Medical Center ( Site 1053)

    Omaha, Nebraska, 68198, United States

  • University of Rochester Medical Center - PPDS ( Site 1039)

    Rochester, New York, 14642, United States

  • University of Texas Southwestern Medical Center ( Site 4002)

    Dallas, Texas, 75390, United States

  • University of Toledo Medical Center ( Site 1070)

    Toledo, Ohio, 43614, United States

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden. ( Site 1501)

    Dresden, Saxony, 01307, Germany

  • Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)

    Giessen, Hesse, 35392, Germany

  • Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 2803)

    Bialystok, Podlaskie Voivodeship, 15-276, Poland

  • Washington University School of Medicine [Saint Louis, MO] ( Site 1022)

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical College ( Site 1046)

    New York, New York, 10021-9800, United States

  • West Virginia University ( Site 1081)

    Morgantown, West Virginia, 26506, United States

  • Winchester Chest Clinic ( Site 1093)

    New Haven, Connecticut, 06519-1304, United States

  • Wojewodzki Specjalistyczny Szpital im dr WI Bieganskiego w Lodzi ( Site 2807)

    Lodz, Łódź Voivodeship, 91-347, Poland

  • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 2806)

    Lubin, Lublin Voivodeship, 20-718, Poland

  • ZIV Medical Center ( Site 1704)

    Safed, 13100, Israel

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