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New drug aims to heal hearts after attack – but trial halted early

NCT ID NCT06139328

Disease control Sponsor: Boehringer Ingelheim 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This study tested an experimental drug called BI 765845 in 160 adults who had just had a heart attack. Participants received either the drug or a placebo, and doctors measured heart damage using MRI scans over 3 months. The trial was terminated early, so it is unclear if the drug helps reduce heart injury.

What this could mean

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

Active substance
BI 765845 (an experimental drug given as an intravenous infusion or bolus injection)
What this could lead to
If successful, this could point toward a treatment to reduce heart muscle damage after a heart attack, potentially improving recovery.
What could go wrong
This trial was terminated early, so results are limited. It is a Phase 2 study with only 160 participants, and the drug may not prove effective or safe in larger populations.

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

160 people

The number who actually took part.

Started

Dec 2023

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.

Inclusion Criteria: 1. Age ≥18 years (or legal age as per local regulations) at the time of signing informed consent 2. Signed and dated written informed consent in accordance with ICH Good Clinical Practice (GCP) and local legislation prior to admission to the trial. 3. Male or female participants of non-childbearing potential. Male participants must be ready and able to use highly effective methods of birth control per ICH M3 (R2) for at least 5 days following investigational medicinl product (IMP) administration. Women who are not of childbearing potential are considered those that fulfil at least one or more of the following: aged 50 years or above and being naturally amenorrhoeic for at least 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential) OR have premature ovarian failure confirmed by a gynaecologist OR have undergone bilateral salpingo-oophorectomy OR have undergone hysterectomy OR are affected by Turner syndrome OR have uterine agenesis 4. Onset of symptoms of myocardial ischaemia or myocardial infarct, according to patient report, within a duration of: Part A: ≥1 hour (h) and ≤12 h prior to randomisation Part B: ≥1 h and ≤12 h prior to randomisation Further inclusion criteria apply. Exclusion Criteria: 1. Women of childbearing potential 2. Patients indicated for rescue PCI (i.e. after receiving fibrinolysis) 3. Patients presenting with cardiogenic shock defined as either systolic blood pressure (SBP) ≤90 mmHg persisting despite fluid challenge or inotropes/vasopressors use to maintain SBP \>90 mmHg. 4. Known history of symptomatic heart failure (HF) with left ventricular systolic dysfunction (i.e. HFrEF) based on verbal medical history as reported by a trial participant or authorised representative 5. Known history of myocardial infarction (MI) with the exception of the index event (based on verbal medical history as reported by a trial participant or authorised representative) 6. Previous coronary artery bypass grafting (CABG) (based on verbal medical history as reported by a trial participant or authorised representative) Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

acute myocardial infarction myocardial infarction

As listed by the trial registrant

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

Myocardial infarction

Contacts and locations

Locations

  • A.O. San Gerardo di Monza

    Monza, 20900, Italy

  • American Heart of Poland Sp. z o.o.-Tychy-44644

    Tychy, 43-100, Poland

  • American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre

    Chrzanów, 32-500, Poland

  • Asklepios Klinik Langen-Seligenstadt GmbH

    Langen, 63225, Germany

  • Auckland City Hospital

    Grafton / Auckland, 1023, New Zealand

  • Azienda Ospedaliera Cannizzaro

    Catania, 95126, Italy

  • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

    Cona (FE), 44124, Italy

  • Cardiocenter Nitra, s.r.o

    Nitra, 949 01, Slovakia

  • Cardiovascular Diseases institute of Central Slovakia

    Banská Bystrica, 97401, Slovakia

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0C1, Canada

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353, Germany

  • Complejo Hospitalario Universitario de Vigo

    Vigo, 36312, Spain

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • General University Hospital

    Prague, 128 00, Czechia

  • Golden Jubilee National Hospital

    Clydebank, G81 4DY, United Kingdom

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2, Canada

  • Hanyang University Medical Center

    Seoul, 04763, South Korea

  • Helios Herzzentrum Leipzig GmbH

    Leipzig, 04289, Germany

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28009, Spain

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Virgen De La Macarena

    Seville, 41009, Spain

  • Independent Public Health Care Center of the Ministry of the Interior in Rzeszow

    Rzeszów, 35-111, Poland

  • Independent Public Health Care in Myszkow

    Myszków, 42 300, Poland

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

    Québec, G1V 4G5, Canada

  • Klinikum der Stadt Ludwigshafen am Rhein GmbH

    Ludwigshafen, 67063, Germany

  • Leeds General Infirmary

    Leeds, LS1 3EX, United Kingdom

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • NCKUH

    Tainan, 704, Taiwan

  • National Heart Centre Singapore

    Singapore, 169609, Singapore

  • National Institute of Cardiovascular Diseases

    Bratislava, 831 01, Slovakia

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • National University Hospital-Singapore-42005

    Singapore, 119074, Singapore

  • Osp. Pediatrico Apuano Pasquinucci

    Massa, 54100, Italy

  • Ospedale Mauriziano di Torino

    Torino, 10128, Italy

  • Ospedale San Paolo-Bari-18924

    Bari, 70124, Italy

  • Semmelweis University

    Budapest, 1122, Hungary

  • Sengkang General Hospital

    Singapore, 544886, Singapore

  • South Western Sydney Local Health District

    Liverpool, New South Wales, 2170, Australia

  • St. Anna Hospital

    Brno, 602 00, Czechia

  • Städtisches Klinikum Dresden

    Dresden, 01067, Germany

  • The Northern Hospital

    Epping, Victoria, 3076, Australia

  • University Clinical Hospital in Opole

    Opole, 45-401, Poland

  • University Hospital Brno

    Brno, 62500, Czechia

  • University Hospital in Krakow

    Krakow, 30-688, Poland

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • University of Pecs

    Pécs, 7624, Hungary

  • Universität Leipzig

    Leipzig, 04103, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Zala County Hospital, Zalaegerszeg

    Zalaegerszeg, 8900, Hungary

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