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Heart failure drug trial halted early – what we know

NCT ID NCT06237309

Disease control Sponsor: Regeneron Pharmaceuticals 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a single dose of an experimental antibody called REGN5381 in 89 people with chronic heart failure and reduced pumping ability. The goal was to check safety, how the drug moves in the body, and its effects on heart stress markers. The trial was terminated early, so final results are not available.

What this could mean

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

Active substance
REGN5381 (an experimental antibody given as a single intravenous infusion)
What this could lead to
If successful, this could point toward a new treatment to help manage chronic heart failure by improving heart function.
What could go wrong
This was an early phase 2 trial that was terminated, so results are limited. The drug is still experimental and may not prove safe or effective.

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

89 people

The number who actually took part.

Started

Apr 2024

Finished

Dec 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.

Key Inclusion Criteria 1. Body mass index (BMI) between 18 and 45 kg/m\^2, inclusive, at initial screening visit 2. Diagnosis of chronic heart failure 3. Left ventricular ejection fraction 20-49% by echocardiogram performed within 3 months of screening 4. Plasma NT-proBNP ≥800 pg/mL (or ≥1000 pg/mL if in atrial fibrillation) at screening (visit 1) and NT-proBNP ≥600 pg/mL (or ≥800 pg/mL if in atrial fibrillation) approximately 30 days prior to randomization (visit 5) 5. Receiving optimized standard of care therapy for heart failure as described in the protocol 6. Sacubitril-valsartan treatment: a. Treatment with sacubitril-valsartan at screening and at baseline permitted in Part A2 sacubitril-valsartan cohort and in Part B if supported by safety data from the Part A2 sacubitril-valsartan cohort as described in the protocol 7. Estimated Glomerular Filtration Rate (eGFR) levels: 1. eGFR of ≥30 mL/min/1.73 m2 according to locally used formula (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] preferred), at screening (visit 1) or approximately 30 days prior to randomization (visit 5) as described in the protocol Key Exclusion Criteria 1. Hospital discharge within 180 days of anticipated randomization 2. Resting SBP that remains out of range after two repeated measurements prior to randomization as described in the protocol 3. Current or recent diagnosis of acute coronary syndrome or myocardial infarction as described in the protocol 4. History of symptomatic autonomic dysfunction as evidenced by orthostatic hypotension and/or syncope 5. Unexplained syncope \<12 months prior to initial screening or during the Run-in period 6. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator that may confer unreasonable risk to the participant's participation in the study 7. Uncorrected congenital heart disease 8. Cardiac surgery within 6 months prior to screening or any planned surgery during the study 9. Implantation of a cardiac resynchronization therapy device in the prior 90 days, or planned during the study, or planned device optimization 30 days prior to randomization or during the study 10. Current chronic lung disease requiring long-term oxygen therapy Note: Other protocol-defined inclusion/ exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

heart failure systolic 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

  • AZ Oostende

    Ostend, West Vlaanderen, 8400, Belgium

  • Algemeen Ziekenhuis Groeninge

    Kortrijk, West Vlaanderen, 8500, Belgium

  • Algemeen Ziekenhuis St Jan Brugge Oostende Av

    Bruges, West Flanders, 8000, Belgium

  • Anima Research Center

    Alken, Limburg, 3570, Belgium

  • Arensia Exploratory Medicine Clinic

    Phoenix, Arizona, 85015, United States

  • Arensia Exploratory Medicine Clinic at MBAL Sveta Sofia

    Sofia, 1618, Bulgaria

  • Arensia Exploratory Medicine Clinic at Monza Bucharest

    Bucharest, 11658, Romania

  • Arensia Exploratory Medicine at the Research Institute of Clinical Medicine

    Tbilisi, 0112, Georgia

  • Athens Naval Hospital

    Athens, Attikh, 11521, Greece

  • Centre Hospitalier Regional de la Citadelle

    Liège, 4000, Belgium

  • Clinmedica Research sp zo.o.

    Skierniewice, Łódź Voivodeship, 96-100, Poland

  • Dr M I Sarvan,R Moodley & partners

    Durban, KwaZulu-Natal, 4321, South Africa

  • Edumed

    Jaroměř, 55101, Czechia

  • Fakultni Nemocnice v Motole

    Prague, Central Bohemian, 15006, Czechia

  • First Cardiology Clinic University of Athens

    Athens, Attica, 11527, Greece

  • Flourish Research - Miami (Kendall) (Formerly Clinical Site Partners)

    Miami, Florida, 33186, United States

  • Flourish Research - Orlando (Formerly Clinical Site Partners)

    Winter Park, Florida, 32789, United States

  • General University Hospital Attikon

    Chaïdári, 12462, Greece

  • Grand Hopital de Charleroi

    Gilly, Hainaut, 6060, Belgium

  • Harbor UCLA Medical Center

    Torrance, California, 90509, United States

  • Hospital Arnau de Vilanova

    Valencia, 46015, Spain

  • Hospital Universitario Virgen Macarena Unidad Coronaria 1 planta

    Seville, 41009, Spain

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120, Spain

  • Into Research

    Groenkloof, Gauteng, 0181, South Africa

  • Korea University Guro Hospital

    Seoul, 8308, South Korea

  • Kuils River Hospital

    Kuils River, Western Cape, 7580, South Africa

  • Larissa University Hospital

    Larissa, 41110, Greece

  • MHAT Haskovo

    Haskovo, 6300, Bulgaria

  • Medical University of Lodz

    Lodz, 90-549, Poland

  • Medicus Services s.r.o.

    Brandýs nad Labem-Stará Boleslav, 25001, Czechia

  • NZOZ Gemini

    Żychlin, 62-571, Poland

  • Onze Lieve Vrouw Ziekenhuis Aalst

    Aalst, Oost-Vlaanderen, 9300, Belgium

  • Pmsi Republican Clinical Hospital Timofei Mosneaga

    Chisinau, MD-2025, Moldova

  • Sc Arensia Exploratory Medicine Srl

    Cluj-Napoca, 400006, Romania

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Severance Hospital at Yonsei University College of Medicine

    Seoul, Seodaemun-gu, 03722, South Korea

  • UCK Medical University of Warsaw

    Warsaw, Masovian Voivodeship, 02-097, Poland

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000, Belgium

  • University Hospital Brno

    Brno, South Moravian, 62500, Czechia

  • University Multiprofile Hospital for Active Treatment Plovdiv

    Plovdiv, 4000, Bulgaria

  • Virgen de las Montañas Hospital

    Villamartín, Cadiz, 11650, Spain

  • Wojewodzki Szpital Zespolony - Ludwik Rydygier Provincial Hospital

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426, South Korea

  • Worthwhile Clinical Trials

    Benoni, Gauteng, 1500, South Africa

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