Heart failure drug trial halted early – what we know

NCT ID NCT05492500

Symptom relief Sponsor: Pfizer Source: ClinicalTrials.gov ↗

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

Summary

This Phase 2 study tested ponsegromab, an experimental drug, against a placebo in 455 adults with heart failure. Participants received injections every four weeks for about nine months. The goal was to see if ponsegromab could improve symptoms and quality of life. The trial was terminated early, so final results are limited.

What this could mean

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

Active substance: Ponsegromab (also known as PF-06946860)
What this could lead to: If it works, this could point toward a new treatment to ease symptoms and improve quality of life for people with heart failure.
What could go wrong: This trial was terminated early, so results may be incomplete. It is still in Phase 2, meaning it is not yet proven safe or effective. The study is small and may not apply to all heart failure patients.

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

455 people

The number who actually took part.

Started

Sep 2022

Finished

Mar 2025

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 years and older

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: * Male and female participants aged 18 years or older -. Clinical evidence of HF with each of the following criteria: 1. LVEF \<50% on most recent measurement, within 12 months of screening. Note: An assessment of LVEF in the prior 12 months is not required in situations where LVEF has been persistently \<50% on prior assessments obtained at least 3 months apart (including the most recent measurement). 2. NYHA class II-IV at screening. 3. NT-proBNP ≥400 pg/mL at screening (Note: Does not apply to open-label, PK Cohort \[Cohort B\]). * Serum GDF-15 concentration ≥2000 pg/mL at screening. * Cohort D only: Serum GDF-15 concentration \<2000 pg/mL at screening. * KCCQ-23 CSS \<75 at screening (Note: Does not apply to open-label, PK Cohort \[Cohort B\]). * Evidence of cachexia or fatigue or functional impairment, as demonstrated by at least one of the following at screening (Note: Does not apply to open-label, PK Cohort \[Cohort B\]): 1. Non-edematous unintentional weight loss ≥5% in the last 6 months or current BMI \<20 kg/m2, associated with subjective fatigue or anorexia; or 2. Fatigue at least 3 times per week AND at least moderately bothersome fatigue in the past 2 weeks based on the KCCQ-23 administered at screening; or 3. A score of \<60 on the Physical Limitations Domain of the KCCQ 23 administered at screening. Exclusion Criteria: * Acute decompensated HF within 1 month prior to Screening Visit 1 or during the screening period. * Implantation of a cardiac resynchronization therapy device or valve repair or replacement within 3 months prior to randomization or intent to do so during the trial. For the open-label, PK cohort (Cohort B) only: implantation of a cardiac resynchronization therapy device more than 1 month prior to randomization is permitted. * History of heart transplantation, currently listed for heart transplant, current/planned mechanical circulatory support, or current/planned use of intravenous inotropes (eg, dobutamine, milrinone). * Acute coronary syndrome within 1 month prior to randomization. * Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) within 3 months prior to randomization or intent to undergo coronary revascularization during the trial. For the open-label, PK cohort (Cohort B) only: coronary revascularization more than 1 month prior to randomization is permitted. * Untreated indication for an implantable cardiac defibrillator or pacemaker to treat a cardiac rhythm abnormality (ie, tachyarrhythmia or bradyarrhythmia). * Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives (whichever is longer) preceding the first dose of study intervention used in this study. Treatment with an investigational biologic agent within 6 months or 5 half-lives (whichever is longer) of Day 1. * Previous exposure to ponsegromab in a prior clinical study. * Renal disease requiring ongoing dialysis. * Cirrhosis with evidence of portal hypertension not due to HF, or the following LFT abnormalities at the time of screening, confirmed by a repeat test if deemed necessary: AST or ALT level ≥ 3 x ULN, or total bilirubin level ≥ 2 x ULN (unless history of Gilbert's syndrome).

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

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

Heart failure

Contacts and locations

Locations

Barnet Hospital

Barnet, EN5 3DJ, United Kingdom
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña [LA Coruña], 15006, Spain
CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruña [LA Coruña], 15706, Spain
CardioVasc HR Inc

Saint-Jean-sur-Richelieu, Quebec, J3A 1J2, Canada
Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada
Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur.

Terrebonne, Quebec, J6V 2H2, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski

Rimouski, Quebec, G5L 5T1, Canada
Chicago Medical Research

Hazel Crest, Illinois, 60429, United States
China-Japan Union Hospital

Changchun, Jilin, 130033, China
Clinical and Translational Research Center

Chapel Hill, North Carolina, 27599, United States
Community Care Building

Winchester, Ontario, K0C 2K0, Canada
Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia
Corcare

Toronto, Ontario, M1B 5N1, Canada
Core Research Group

Brisbane, Queensland, 4064, Australia
Diex Recherche Trois-Rivieres

Trois-Rivières, Quebec, G9A 4P3, Canada
Dél-Pesti Centrumkórház Orszagos Hematologiai es Infektologiai Intezet

Budapest, 1097, Hungary
EDUMED - Jaroměř

Jaroměř, Náchod, 551 01, Czechia
Eastern shore Research Institute LLC

Fairhope, Alabama, 36532, United States
Emory University School of Medicine-Grady Campus

Atlanta, Georgia, 30303, United States
Fakultni Nemocnice u sv. Anny v Brne

Brno, South Moravian, 602 00, Czechia
Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia
Fraser Clinical Trials Inc

New Westminster, British Columbia, V3L 3W4, Canada
Glasgow Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom
Golden Jubilee National Hospital

Clydebank, G81 4DY, United Kingdom
Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China
Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien

Dresden, Saxony, 01277, Germany
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
Higashi Takarazuka Satoh Hospital

Takarazuka, Hyōgo, 665-0873, Japan
Holy Name Medical Center

Teaneck, New Jersey, 07666, United States
Hospital Clinico de Valencia

Valencia, Valenciana, Comunitat, 46010, Spain
Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Región de, 30120, Spain
Hospital General Universitario de Valencia

Valencia, 46014, Spain
Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], 08035, Spain
Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain
Hospital Universitario Central de Asturias

Oviedo, 33011, Spain
Hospital Universitario La Paz

Madrid, 28046, Spain
Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Comunidad de, 28222, Spain
Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, 28034, Spain
Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain
Hospital Universitario Virgen Nieves

Granada, 18012, Spain
Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain
Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [cataluña], 08041, Spain
Hyogo Prefectural Amagasaki General Medical Center

Amagasaki, Hyōgo, 660-8550, Japan
Hyogo Prefectural Harima-Himeji General Medical Center

Himeji, Hyōgo, 670-8560, Japan
Institut Klinicke a Experimentalni Mediciny

Prague, Praha 4, 140 21, Czechia
Institut de Cardiologie de Montreal

Montreal, Quebec, H1T 1C8, Canada
Iwate Prefectural Central Hospital

Morioka, Iwate, 020-0066, Japan
Kanizsai Dorottya Korhaz

Nagykanizsa, 8800, Hungary
Kardio Brynow

Katowice, Silesian Voivodeship, 40-555, Poland
Kawartha Cardiology Clinical Trials

Peterborough, Ontario, K9J 0B2, Canada
Keck Medical Center of USC

Los Angeles, California, 90033, United States
Keio University Hospital

Shinjuku-ku, Tokyo, 160-8582, Japan
Kishiwada Tokushukai Hospital

Kishiwada, Osaka, 596-0042, Japan
Lincoln County Hospital

Lincoln, LN2 5QY, United Kingdom
Liverpool University Hospitals NHS Foundation Trust

Liverpool, L9 7AL, United Kingdom
Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112, Australia
M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, 55455, United States
M Health Fairview University of Minnesota Investigational Drug Services

Minneapolis, Minnesota, 55455, United States
M Health Fairview University of Minnesota Medical Center-East Bank

Minneapolis, Minnesota, 55455, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Medifarma 98 Kft

Nyíregyháza, Nyíregyháza, 4400, Hungary
Miejski Szpital Zespolony w Olsztynie

Olsztyn, Warmian-Masurian Voivodeship, 10-045, Poland
National Cerebral and Cardiovascular Center

Suita, Osaka, 564-8565, Japan
National Hospital Organization Saitama Hospital

Wako, Saitama, 351-0102, Japan
National Hospital Organization Sendai Medical Center

Sendai, Miyagi, 983-8520, Japan
Ninewells Hospital and Medical School

Dundee, Dundee CITY, DD1 9SY, United Kingdom
North York Diagnostic and Cardiac Centre

North York, Ontario, M6B 3H7, Canada
Northern General Hospital

Sheffield, S5 7AU, United Kingdom
Northwick Park Hospital

Harrow, London, CITY of, HA1 3UJ, United Kingdom
Osaka General Medical Center

Osaka, 558-8558, Japan
Parc de Salut Mar - Hospital del Mar

Barcelona, Barcelona [barcelona], 08003, Spain
Peking University First Hospital

Beijing, 100034, China
Polsko Amerykanskie Kliniki Serca

Tychy, 43-100, Poland
Private Practice - Dr. James Cha

Oshawa, Ontario, L1J 2K1, Canada
Private Practice - Dr. Lakatos Ferenc

Békéscsaba, Bekes County, 5600, Hungary
Pécsi Tudományegyetem Klinikai Központ

Pécs, Baranya, 7624, Hungary
QEII Health Sciences Centre - Victoria General Site

Halifax, Nova Scotia, B3H 3A7, Canada
Qilu Hospital of Shandong University

Jinan, Shandong, 250014, China
Reid Physician Associates

Richmond, Indiana, 47374, United States
Royal Papworth Hospital NHS Foundation Trust

Cambridge, CB2 0AY, United Kingdom
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, 92-213, Poland
Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States
Saul Vizel Professional Medicine Corporation dba Vizel Cardiac Research

Cambridge, Ontario, N1R 7R1, Canada
Semmelweis Egyetem

Budapest, 1122, Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház

Kaposvár, Somogy County, 7400, Hungary
South Oklahoma Heart Research, LLC

Oklahoma City, Oklahoma, 73135, United States
St. George's Hospital

London, England and Wales, SW17 0QT, United Kingdom
TaNa Med

Mosonmagyaróvár, Győr-Moson-Sopron, 9200, Hungary
Texas Health Heart & Vascular Specialist (THHVS) #18760

Dallas, Texas, 75231, United States
The Alfred Hospital

Melbourne, Victoria, 3004, Australia
The First Affiliated Hospital of University of South China

Hengyang, Hunan, 421001, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China
The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China
The Prince Charles Hospital

Chermside, Queensland, 4032, Australia
The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China
Tianjin People' s Hospital

Tianjin, Tianjin Municipality, 300120, China
Traverse Heart & Vascular

Traverse City, Michigan, 49684, United States
Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada
University Hospital - London Health Sciences Centre

London, Ontario, N6A 5A5, Canada
University Hospital of North Tees

Stockton-on-Tees, TS19 8PE, United Kingdom
University of Minnesota/Lillehei Clinical Research Unit

Minneapolis, Minnesota, 55455, United States
University of North Carolina Medical Center

Chapel Hill, North Carolina, 27514, United States
Universitätsklinikum Frankfurt Goethe-Universität

Frankfurt am Main, Hesse, 60590, Germany
Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany
Universitätsklinikum Jena

Jena, Thuringia, 7743, Germany
Universitätsmedizin Göttingen - Georg-August-Universität

Göttingen, Lower Saxony, 37075, Germany
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland
Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, Podlaskie Voivodeship, 15-276, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Greater Poland Voivodeship, 61-848, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny

Warsaw, 02-097, Poland
Ustredni vojenska nemocnice

Prague, 16902, Czechia
Vseobecna fakultni nemocnice v Praze

Prague, 12808, Czechia
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Washington University in St. Louis Center for Advanced Medicine (CAM)

St Louis, Missouri, 63110, United States
Washington University in St. Louis Center for Outpatient Health (COH)

St Louis, Missouri, 63108, United States
Winchester District Memorial Hospital

Winchester, Ontario, K0C 2K0, Canada
Wycombe General Hospital

High Wycombe, Buckinghamshire, HP11 2TT, United Kingdom
Yuncheng Central Hospital

Yuncheng, Shanxi, 044000, China
Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality, 200032, China

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