ClinicalTrials.gg
RecruitingNCT06832722PROCARD 2aUpdated Sep 14, 2026

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

A Phase 1/2 interventional study of AK1967 (Invobenitug also known as Procizumab) and Placebo in Shock, Cardiogenic, sponsored by 4TEEN4 Pharmaceuticals GmbH. Recruiting at 37 sites in 9 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by 4TEEN4 Pharmaceuticals GmbH · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Shock, Cardiogenic

Browse trials for

Keywords

  • Cardiogenic shock
  • Procizumab
  • invobenitug
03

In context

Shock, Cardiogenic

296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.

This study's planned enrollment of 90 is above the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.

Browse Shock, Cardiogenic studies →

Lead sponsor

4TEEN4 Pharmaceuticals GmbH is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed .
  2. Diagnosis of CS based on the following entry criteria:

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

Exclusion criteria

Exclusion Criteria:

  1. Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP.
  2. Patients being longer than 24 hours in the ICU at the time of randomization.
  3. Patients below the age of 18 or above 80 years.
  4. Patients receiving Ang II and/or levosimendan
  5. Patients with known allergies or to the IMP or its or any related medication.
  6. Stroke or within the last 3 months.
  7. SCAI Shock Stage E.
  8. Reduced of less than 6 months due to comorbidities (prior to shock onset).
  9. Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death.
  10. 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.
  11. Patients exceeding a maximum body weight of 120 kg (EU, Armenia, Serbia) and 150 kg (US).
  12. CPR lasting more than 15 minutes and/or the patient is not conscious at randomization.
  13. Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease.
  14. Pericardial constriction.
  15. Sustained SBP > 120 mmHg during the hour prior to randomization.
  16. Known severe chronic liver disease (Model for End-Stage Liver Disease (MELD) Score >30), known severe chronic pulmonary disease (including 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 \<20 ml/min/1.73 m2 or chronic dialysis.
  17. Patients with untreated sepsis.
  18. Patients with valvular heart diseases as the primary cause of cardiogenic shock.
  19. Other known causes of shock, namely

    1. Hypovolemia
    2. Hemorrhage
    3. Anaphylaxis
    4. Intoxication (e.g., drug-induced shock)
    5. Dynamic left ventricular outflow tract obstruction
    6. isolated right heart failure, including cardiac tamponade and/or pulmonary embolism
    7. Known mechanical complications due to myocardial infarction, including papillary muscle rupture, ventricular septal rupture, free wall rupture
    8. Inappropriate pacing or shock resulting from ICD malfunction
  20. Patients who have severe immune suppression: recent (\<3 months) chemotherapy and/or severe neutropenia (neutrophile count \<500 cells/mm3) and/or chronic high dose (≥0.5 mg/kg per day of prednisone equivalent) and/or recent (\<3 months) organ transplantation.
  21. 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.
  22. Women who are pregnant or breastfeeding.
  23. Patients who are currently enrolled in another clinical trial, or who have participated in such trials within one month prior to randomization.
  24. Any reason that the investigator anticipates that the patient will be unable to complete the protocol or its required procedures (US only).
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
90 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

  • Active comparator
    Invobenitug also known as Invobenitug (AK1967) 10mg/kg body weight

    Drug: AK1967 (Invobenitug also known as Procizumab)

Interventions

  • DrugAK1967 (Invobenitug also known as Procizumab)

    DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)

  • DrugPlacebo

    Application of placebo

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Pharmacokinetics defined as plasma-time concentration of invobenitug

    Time frame: 30 days

  2. Pharmacodynamics defined as cDPP3 concentration

    Time frame: 30 days

  3. Pharmcodynamics defined as cDPP3 activity

    Time frame: 30 days

07

Study locations

16 of 37 sites recruiting
  • Yerevan medical scientific center
    Yerevan, 0014, Armenia
    Not yet recruiting
    • Harutyun Ghrmajyan, Dr. · Contact
  • Erebouni Mwdical Center
    Yerevan, 0087, Armenia
    Not yet recruiting
    • Hamlet Hayrapetyan · Contact
  • Heart Center Aalst, AZORG
    Aalst, Belgium
    Recruiting
    • Christophe Vandenbriele · Contact
  • University Hospital Saint Pierre
    Brussels, Belgium
    Recruiting
  • Ghent University Hospital
    Ghent, Belgium
    Not yet recruiting
    • Hanna Schaubroeck, Dr. · Contact
  • University Hospital and Medical Faculty of Pilsen
    Pilsen, Czechia
    Recruiting
    • Richard Rokyta · Contact
  • Charles University Motol University Hospital
    Prague, Czechia
    Recruiting
    • Petr Ostadal · Contact
  • General University Hospital in Prague - FVN
    Prague, Czechia
    Recruiting
  • Institute of Clinical and Experimental Medicine - IKEM
    Prague, Czechia
    Recruiting
  • University Hospital Avicenne AP-HP
    Bobigny, France
    Recruiting
  • Département d'anesthésie-réanimation
    Dijon, 21000, France
    Not yet recruiting
    • Pierre-Grégoire Guinot, PhD, MD · Contact
  • University Hospital Lille - Institut Cœur Poumon
    Lille, France
    Recruiting
  • University Hospital - Dupuytren Limoges
    Limoges, France
    Recruiting
  • Regional University Hospital Nancy - Hopitaux de Brabois
    Nancy, France
    Recruiting
  • Hôpital Pitié Salpêtrière
    Paris, 75651, France
    Not yet recruiting
    • Alain Combes, PhD, MD · Contact
  • Lariboisière Hospital AP-HP
    Paris, France
    Recruiting
  • Deutsches Herzzentrum der Charite (DHZC)
    Berlin, Germany
    Not yet recruiting
    • Carsten Skurk, Prof. Dr. med. · Contact
  • Universitätsklinikum Freiburg
    Freiburg im Breisgau, Germany
    Not yet recruiting
    • Lucas Bacmeister, Dr. med. · Contact
  • University Medical Center Hamburg-Eppendorf
    Hamburg, Germany
    Not yet recruiting
    • Stefan Kluge, Prof. Dr. med. · Contact
  • Herzzentrum Leipzig GmbH
    Leipzig, Germany
    Not yet recruiting
    • Holger Thiele, Prof. Dr. med. · Contact
  • Universitätsmedizin Mannheim
    Mannheim, Germany
    Not yet recruiting
    • Ibrahim Akin, Prof. Dr. med. · Contact
  • Radboud University Medical Center
    Nijmegen, Netherlands
    Recruiting
  • Uniersytecki Szpital Kliniczny w Białystoku
    Bialystok, Poland
    Recruiting
    • Agnieszka Tycińska · Contact
  • Górnośląskie Centrum Medyczne w Katowicach / Śląski Uniwersytet Medyczny w Katowicach
    Katowice, Poland
    Recruiting
    • Maciej Wybraniec · Contact
  • Clinical University Hospital Poznań
    Poznan, Poland
    Recruiting
  • J. Mikulicz Radecki Clinical University Hospital Wrocław
    Wroclaw, Poland
    Recruiting
  • Clinical Hospital Center Bezanijska Kosa
    Belgrade, Serbia
    Not yet recruiting
    • Marija Zdravkovic, PhD, MD · Contact
  • Institute for Cardiovascular Diseases of Vojvodina
    Kamenitz, Serbia
    Not yet recruiting
    • Sonja Dimic, MD · Contact
  • Clinical Center Niš
    Niš, Serbia
    Not yet recruiting
    • Bojan Maricic, Dr. · Contact
  • Fundación Pública Galega de Investigación Biomédica INIBIC
    A Coruña, Spain
    Not yet recruiting
    • Miguel Solla-Buceta, Dr. · Contact
  • Fundació Hospital Universitari Vall d'Hebron
    Barcelona, Spain
    Not yet recruiting
    • Aitor Uribarri González, Dr. · Contact
  • Fundació Hospital Universitari Vall d'Hebron
    Barcelona, Spain
    Not yet recruiting
    • Ricard Ferrer Roca, PhD, MD · Contact
  • Hospital Clinic de Barcelona
    Barcelona, Spain
    Not yet recruiting
    • Rut Andrea Riba, PhD, MD · Contact
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, Spain
    Not yet recruiting
    • Alessandro Sionis, Dr. · Contact
  • L'Hospitalet de Llobregat
    Barcelona, Spain
    Not yet recruiting
    • Albert Ariza-Sole, Dr. · Contact
  • Fundación para la Investigación Biomédica del Hospital Universitario La Paz
    Madrid, Spain
    Not yet recruiting
    • Isabel Antorrena, Dr. · Contact
  • Hospital Universitario 12 De Octubre
    Madrid, Spain
    Not yet recruiting
    • Roberto Martin, Dr. · Contact
08

References and documents

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 ↗

Related links

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2025 (actual). Primary completion is estimated for Dec 2026, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2025
First posted
Feb 18, 2025
StartActual
Jul 13, 2025
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06832722
Lead sponsor
4TEEN4 Pharmaceuticals GmbH
Responsible party
Sponsor
First posted
Feb 18, 2025
Start date
Jul 13, 2025
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 14, 2026

Study contacts

Karakas Mahir, Prof. Dr. Dr.
Contact
karakas@4teen4.de
+49 173 3060687
Peter Szecsödy, MD
Contact
szecsoedy@4teen4.de
+46 707878737
Alexandre Mebazaa, Professor
principal investigator · Hôpital Lariboisière, Paris France
David A. Morrow, MD, MPH
principal investigator · TIMI study Group (An ARO of Brigham & Women's Hospital and an Affiliate of Harvard Medical School)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion