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Shock, CardiogenicPhase 1/2PROCARD 2aNCT06832722

A Phase 1b/2a Trial to Evaluate Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care.

A Phase 1/2 study testing AK1967 (Invobenitug also known as Procizumab) in people with Shock, Cardiogenic, run by 4TEEN4 Pharmaceuticals GmbH at 37 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The objective of this Phase 1b/2a trial is to evaluate the safety, tolerability, and exploratory efficacy of invobenitug (also known as procizumab), a monoclonal antibody under development for the treatment of cardiogenic shock (CS). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Shock, Cardiogenic
What is being tested?
AK1967 (Invobenitug also known as Procizumab)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
37 sitesin 9 countries
Study dates
13 Jul 2025to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent.
  • Diagnosis of CS based on the following entry criteria:
  • Need for ongoing vasopressors and/or inotropes to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg
  • Lactate ≥ 2.0 mmol/L
  • High DPP3 concentration ≥ 30 ng/mL
  • Etiology of CS must be one of the following: ACS, septic (according to SEPSIS 3 criteria) or adHF origin

Who cannot join

  • Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP.
  • Patients being longer than 24 hours in the ICU at the time of randomization.
  • Patients below the age of 18 or above 80 years.
  • Patients receiving Ang II and/or levosimendan
  • Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication.
  • Stroke or transient ischemic attack within the last 3 months.
Show all 32Show fewer
  • SCAI Shock Stage E.
  • Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset).
  • Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death.
  • Only for Part 1: Patients on cannula-based MCS (including VV and VA-ECMO, impella or left ventricular assist device of any type (excluding IABP)) or on renal replacement therapy. Patients who are treated by impella and/or ECMO but have no evidence of hemolysis during screening can be enrolled in the trial.
  • Patients exceeding a maximum body weight of 120 kg (EU, Armenia, Serbia) and 150 kg (US).
  • CPR lasting more than 15 minutes and/or the patient is not conscious at randomization.
  • Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease.
  • Pericardial constriction.
  • Sustained SBP > 120 mmHg during the hour prior to randomization.
  • Known severe chronic liver disease (Model for End-Stage Liver Disease (MELD) Score >30), known severe chronic pulmonary disease (including COPD classification GOLD4 and/or chronic oxygen therapy and/or restrictive chronic pulmonary failure and/or severe interstitial lung disease), known severe thyroid disease, known CKD with eGFR <20 ml/min/1.73 m2 or chronic dialysis.
  • Patients with untreated sepsis.
  • Patients with valvular heart diseases as the primary cause of cardiogenic shock.
  • Other known causes of shock, namely
  • Hypovolemia
  • Hemorrhage
  • Anaphylaxis
  • Intoxication (e.g., drug-induced shock)
  • Dynamic left ventricular outflow tract obstruction
  • isolated right heart failure, including cardiac tamponade and/or pulmonary embolism
  • Known mechanical complications due to myocardial infarction, including papillary muscle rupture, ventricular septal rupture, free wall rupture
  • Inappropriate pacing or shock resulting from ICD malfunction
  • Patients who have severe immune suppression: recent (<3 months) chemotherapy and/or severe neutropenia (neutrophile count <500 cells/mm3) and/or chronic high glucocorticoid dose (≥0.5 mg/kg per day of prednisone equivalent) and/or recent (<3 months) organ transplantation.
  • Patients who have undergone any form of surgery in the last 7 days, except 1) minor surgeries such as cosmetic surgeries, skin surgery, dental surgery and impella implantation 2) surgery for peritonitis with adequate source control, which are allowed.
  • Women who are pregnant or breastfeeding.
  • Patients who are currently enrolled in another clinical trial, or who have participated in such trials within one month prior to randomization.
  • Any reason that the investigator anticipates that the patient will be unable to complete the protocol or its required procedures (US only).

Trial locations and contacts

37 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Karakas Mahir, Prof. Dr. Dr. contact

+49 173 3060687

karakas@4teen4.de

Peter Szecsödy, MD contact

+46 707878737

szecsoedy@4teen4.de

37 sites in 9 countries

Spain8 sites, 8 recruiting

  • Fundación Pública Galega de Investigación Biomédica INIBIC

    A Coruña

    Miguel Solla-Buceta, Dr.

    Not yet recruiting

  • Fundació Hospital Universitari Vall d'Hebron

    Barcelona

    Aitor Uribarri González, Dr.

    Not yet recruiting

  • Fundació Hospital Universitari Vall d'Hebron

    Barcelona

    Ricard Ferrer Roca, PhD, MD

    Not yet recruiting

  • Hospital Clinic de Barcelona

    Barcelona

    Rut Andrea Riba, PhD, MD

    Not yet recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

    Alessandro Sionis, Dr.

    Not yet recruiting

  • L'Hospitalet de Llobregat

    Barcelona

    Albert Ariza-Sole, Dr.

    Not yet recruiting

  • Fundación para la Investigación Biomédica del Hospital Universitario La Paz

    Madrid

    Isabel Antorrena, Dr.

    Not yet recruiting

  • Hospital Universitario 12 De Octubre

    Madrid

    Roberto Martin, Dr.

    Not yet recruiting

Other trials in Spain

France7 sites, 7 recruiting

  • University Hospital Avicenne AP-HP

    Bobigny

    Adrien Picod, adrien.picod@gmail.com

    Recruiting

  • Département d'anesthésie-réanimation

    Dijon, 21000

    Pierre-Grégoire Guinot, PhD, MD

    Not yet recruiting

  • University Hospital Lille - Institut Cœur Poumon

    Lille

    Gilles Lemesle, 0333 20 44 45 61, gilles.lemesle@chru-lille.fr

    Recruiting

  • University Hospital - Dupuytren Limoges

    Limoges

    Bruno Evrard, bruno.evrard@chu-limoges.fr

    Recruiting

  • Regional University Hospital Nancy - Hopitaux de Brabois

    Nancy

    Antoine Kimmoun, 0033383154079, a.kimmoun@chru-nancy.fr

    Recruiting

  • Hôpital Pitié Salpêtrière

    Paris, 75651

    Alain Combes, PhD, MD

    Not yet recruiting

  • Lariboisière Hospital AP-HP

    Paris

    Benjamin Choustermann, 0033149958515, Benjamin.chousterman@aphp.fr

    Recruiting

Other trials in France

Germany5 sites, 5 recruiting

  • Deutsches Herzzentrum der Charite (DHZC)

    Berlin

    Carsten Skurk, Prof. Dr. med.

    Not yet recruiting

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

    Lucas Bacmeister, Dr. med.

    Not yet recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg

    Stefan Kluge, Prof. Dr. med.

    Not yet recruiting

  • Herzzentrum Leipzig GmbH

    Leipzig

    Holger Thiele, Prof. Dr. med.

    Not yet recruiting

  • Universitätsmedizin Mannheim

    Mannheim

    Ibrahim Akin, Prof. Dr. med.

    Not yet recruiting

Other trials in Germany

Czechia4 sites, 4 recruiting

  • University Hospital and Medical Faculty of Pilsen

    Pilsen

    Richard Rokyta

    Recruiting

  • Charles University Motol University Hospital

    Prague

    Petr Ostadal

    Recruiting

  • General University Hospital in Prague - FVN

    Prague

    Jan Bělohlávek, 420724371594, jan.belohlavek@vfn.cz

    Recruiting

  • Institute of Clinical and Experimental Medicine - IKEM

    Prague

    Marek Sramko, +420776246127, marek.sramko@ikem.cz

    Recruiting

Other trials in Czechia

Poland4 sites, 4 recruiting

  • Uniersytecki Szpital Kliniczny w Białystoku

    Bialystok

    Agnieszka Tycińska

    Recruiting

  • Górnośląskie Centrum Medyczne w Katowicach / Śląski Uniwersytet Medyczny w Katowicach

    Katowice

    Maciej Wybraniec

    Recruiting

  • Clinical University Hospital Poznań

    Poznan

    Aneta Klotzka, Aneta.klotzka@usk.poznan.pl

    Recruiting

  • J. Mikulicz Radecki Clinical University Hospital Wrocław

    Wroclaw

    Jan Biegus, +48 71 736 42 05, jan.biegus@uwm.edu.pl

    Recruiting

Other trials in Poland

Belgium3 sites, 3 recruiting

  • Heart Center Aalst, AZORG

    Aalst

    Christophe Vandenbriele

    Recruiting

  • University Hospital Saint Pierre

    Brussels

    Antoine Herpain, +3225354912, antoine.herpain@stpierre-bru.be

    Recruiting

  • Ghent University Hospital

    Ghent

    Hanna Schaubroeck, Dr.

    Not yet recruiting

Other trials in Belgium

Serbia3 sites, 3 recruiting

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade

    Marija Zdravkovic, PhD, MD

    Not yet recruiting

  • Institute for Cardiovascular Diseases of Vojvodina

    Kamenitz

    Sonja Dimic, MD

    Not yet recruiting

  • Clinical Center Niš

    Niš

    Bojan Maricic, Dr.

    Not yet recruiting

Other trials in Serbia

Armenia2 sites, 2 recruiting

  • Yerevan medical scientific center

    Yerevan, 0014

    Harutyun Ghrmajyan, Dr.

    Not yet recruiting

  • Erebouni Mwdical Center

    Yerevan, 0087

    Hamlet Hayrapetyan

    Not yet recruiting

Other trials in Armenia

Netherlands1 site, 1 recruiting

  • Radboud University Medical Center

    Nijmegen

    Peter Pickkers, Peter.Pickkers@radboudumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Multi-center, Randomized, Placebo-controlled, Double-blind Phase 1b/2a Trial to Investigate Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Invobenitug Also Known as Procizumab (PCZ; AK1967) in Patients With Cardiogenic Shock and Elevated Circulating Dipeptidyl Peptidase 3 (cDPP3) Concentrations.

The objective of this Phase 1b/2a trial is to evaluate the safety, tolerability, and exploratory efficacy of invobenitug (also known as procizumab), a monoclonal antibody under development for the treatment of cardiogenic shock (CS). CS is a life-threatening hypoperfusion of vital organs that frequently results in death. In addition to safety and tolerability, pharmacokinetics and pharmacodynamics of invobenitug are evaluated to define the optimum phase 2 dose (P2D) of invobenitug.

Being tested
AK1967 (Invobenitug also known as Procizumab), Placebo
Keywords
Cardiogenic shock, Procizumab, invobenitug
Medical subject headings
Shock, Cardiogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK1967 (Invobenitug also known as Procizumab)Drug

    DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)

  • PlaceboDrug

    Application of placebo

Study groups in NCT06832722
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo
Invobenitug also known as Invobenitug (AK1967) 10mg/kg body weightActive comparatorNot described
Receives: Drug: AK1967 (Invobenitug also known as Procizumab)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reported number of treatment-emergent adverse events from start of Invobenitug administration up until the last follow-up visit after Invobenitug administration

    Measured: 30 days

Secondary outcomes (3)

  1. Pharmacokinetics defined as plasma-time concentration of invobenitug

    Measured: 30 days

  2. Pharmacodynamics defined as cDPP3 concentration

    Measured: 30 days

  3. Pharmcodynamics defined as cDPP3 activity

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study start13 Jul 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06832722
Sponsor's protocol ID
CT-P1-002
Other IDs
2024-518450-16-00
Acronym
PROCARD 2a
Status last verified
Sep 2026
First submitted
7 Feb 2025
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • van Lier D, Mourisse L, Hollander H, Santos K, Bergmann A, van Herwaarden AE, Kox M, Pickkers P. Safety, tolerability, and pharmacokinetics/-dynamics of the dipeptidyl peptidase 3-inhibiting antibody Procizumab in a first-in-human trial. MAbs. 2026 Dec;18(1):2671468. doi: 10.1080/19420862.2026.2671468. Epub 2026 May 21.

    PubMed 42165327

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK1967 (Invobenitug also known as Procizumab) in people with Shock, Cardiogenic, run by 4TEEN4 Pharmaceuticals GmbH at 37 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Spain, France, Germany, Czechia, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karakas Mahir, Prof. Dr. Dr. (+49 173 3060687, karakas@4teen4.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reported number of treatment-emergent adverse events from start of Invobenitug administration up until the last follow-up visit after Invobenitug administration (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06832722, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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