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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care

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

Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care (NCT06832722) is a Phase 1 / Phase 2 interventional studying Shock, Cardiogenic, sponsored by 4TEEN4 Pharmaceuticals GmbH. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The objective of this Phase 1b trial is to evaluate the safety and tolerability of 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 procizumab are evaluated to define the optimum phase 2 dose (P2D) of procizumab.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Shock, Cardiogenic, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 130 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Shock, Cardiogenic subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Signed willing to sign a consent form. 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 cDPP3 concentration ≥ 30 ng/mL 3. Etiology of CS must be one of the following: ACS, septic or adHF origin Who Should NOT Join This Trial: 4. Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP. 5. Patients being longer than 24 hours in the ICU at the time of randomization. 6. Patients below the age of 18 or above 80 years. 7. Patients receiving Ang II and/or levosimendan. 8. Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication. 9. Stroke or transient ischemic attack within the last 3 months. 10. SCAI Shock Stage E. 11. Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset). 12. Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death. 13. 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. 14. Patients exceeding a maximum body weight of 120 kg. 15. CPR lasting more than 15 minutes and/or the patient is not conscious at randomization. 16. Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease. 17. Pericardial constriction 18. Sustained SBP \> 120 mmHg during the hour prior to randomization. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Signed informed consent. 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 cDPP3 concentration ≥ 30 ng/mL 3. Etiology of CS must be one of the following: ACS, septic or adHF origin Exclusion Criteria: 4. Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP. 5. Patients being longer than 24 hours in the ICU at the time of randomization. 6. Patients below the age of 18 or above 80 years. 7. Patients receiving Ang II and/or levosimendan. 8. Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication. 9. Stroke or transient ischemic attack within the last 3 months. 10. SCAI Shock Stage E. 11. Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset). 12. Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death. 13. 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. 14. Patients exceeding a maximum body weight of 120 kg. 15. CPR lasting more than 15 minutes and/or the patient is not conscious at randomization. 16. Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease. 17. Pericardial constriction 18. Sustained SBP \> 120 mmHg during the hour prior to randomization. 19. 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 disease and/or severe interstitial lung disease), known severe thyroid disease, known CKD with eGFR \< 20 ml/min/1.73 m2 or chronic dialysis. 20. Patients with untreated sepsis. 21. Patients with valvular heart diseases as the primary cause of cardiogenic shock. 22. 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 23. Patients who have severe immune suppression such as recent (\<3 months) chemotherapy and/or severe neutropenia (neutrophil 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 24. 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. 25. Women who are pregnant or breastfeeding. 26. Patients who are currently enrolled in another clinical trial, or who have participated in such trials within one month prior to randomization

Treatments Being Tested

DRUG

AK1967 (Invobenitug also known as Procizumab)

DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)

DRUG

Placebo

Application of placebo

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Yerevan medical scientific center
Yerevan, Armenia
Erebouni Mwdical Center
Yerevan, Armenia
Heart Center Aalst, AZORG
Aalst, Belgium
University Hospital Saint Pierre
Brussels, Belgium
University Hospital and Medical Faculty of Pilsen
Pilsen, Czechia
Charles University Motol University Hospital
Prague, Czechia
General University Hospital in Prague - FVN
Prague, Czechia
Institute of Clinical and Experimental Medicine - IKEM
Prague, Czechia
University Hospital Avicenne AP-HP
Bobigny, France
Département d'anesthésie-réanimation
Dijon, France
University Hospital Lille - Institut Cœur Poumon
Lille, France
University Hospital - Dupuytren Limoges
Limoges, France
Regional University Hospital Nancy - Hopitaux de Brabois
Nancy, France
Hôpital Pitié Salpêtrière
Paris, France
Lariboisière Hospital AP-HP
Paris, France
Radboud University Medical Center
Nijmegen, Netherlands
Uniersytecki Szpital Kliniczny w Białystoku
Bialystok, Poland
Górnośląskie Centrum Medyczne w Katowicach / Śląski Uniwersytet Medyczny w Katowicach
Katowice, Poland
Clinical University Hospital Poznań
Poznan, Poland
J. Mikulicz Radecki Clinical University Hospital Wrocław
Wroclaw, Poland

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06832722), the sponsor (4TEEN4 Pharmaceuticals GmbH), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06832722 clinical trial studying?

The objective of this Phase 1b trial is to evaluate the safety and tolerability of 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 procizumab are evaluated to define the optimum phase 2 dose (P2D) of procizumab. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06832722?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06832722?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06832722. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06832722. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.