Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction After Myocardial Infarction

NCT05350969 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: CDR132L-P2-012023-507569-24-002021-006040-27
• Study Type: interventional
• Target: 294
• Locations: 8 countries
• Sites: 49

Brief Summary

This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess efficacy and safety of CDR132L in patients with reduced Left Ventricular Ejection Fraction (LVEF) (≤ 45%) after myocardial infarction (MI). This study consists of a screening period (to occur at least 3 days after MI diagnosis), a 6-month double-blind period, and a 6-month extension period with the End of Study (EOS) Visit at Day 360/Month 12. Two dosages of CDR132L will be tested against placebo on their effects on patients, who just had a heart attack in addition to standard care. The aim of the study is to show that CDR132L is safe and effective to improve heart failure in such patients.

Conditions

Heart Failure, Left Sided; Myocardial Infarction, Acute

Outcome Measures

Primary Outcomes (1)

• Echocardiography (ECHO)

  Percent change from baseline (screening to occur at least 3 days after MI diagnosis as measured by ECHO \[central laboratory\]) in Left Ventricular End-Systolic Volume (LVESVI) at Month 6.

  6 months

Study Arms (3)

CDR132L 5 mg

EXPERIMENTAL

CDR132L 5 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57

Drug: CDR132L

CDR132L 10 mg

EXPERIMENTAL

CDR132L 10 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57

Drug: CDR132L

Placebo

PLACEBO COMPARATOR

Placebo intravenous in single dose on Day 1, Day 29 and Day 57

Drug: Placebo to CDR132L

Interventions

CDR132L DRUG

CDR132L is a synthetic antisense oligonucleotide (ASO) and a selective inhibitor of microRNA-132-3p (miR-132). miR-132 in cardiomyocytes is a central switch affecting the expression of genes that are crucially involved in maladaptive cardiac remodeling, transformation, and pathological cardiac growth (hypertrophy), contributing to adverse cardiac remodeling and heart failure (HF).1-5 Aberrant expression of miR-132 in cardiac cells is causally associated with cardiac remodeling and HF progression.

CDR132L 10 mg; CDR132L 5 mg

Placebo to CDR132L DRUG

Placebo to CDR132L

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, aged ≥ 30 to ≤ 80 years at the date of signing informed consent which is defined as the beginning of the Screening Period.
• Spontaneous acute mycardial infarction (AMI) (type I) based on the universal MI definition with randomization to occur no later than 14 days after index event diagnosis.
• Patient with a LVEF ≤ 45% as measured by ECHO after MI diagnosis (STEMI or NSTEMI).
• Patient with previous MI events in history can be included.
• Patient with body weight of ≤ 120 kg.
• N-terminal pro B-type natriuretic peptide level ≥ 125 pg/ml and \< 8000 pg/ml at screening.
• Patient with STEMI/NSTEMI who underwent percutaneous coronary intervention for this event.

You may not qualify if:

• A woman of childbearing potential (WOCBP).
• Patient with HF of non-ischemic origin; e.g., myocarditis, alcoholic cardiomyopathy.
• Patient with New York Heart Association (NYHA) class IV at screening or randomization.
• Patient has any planned cardiac intervention (angiogram without angioplasty is acceptable) or any other planned surgery after the Screening Period.
• Patient has severe valvular heart disease.
• Patient has systolic BP \< 90 mmHg or \> 180 mmHg, diastolic BP \< 50 mmHg or \> 110 mmHg, and/or heart rate \< 50 or \> 100 beats/minute at screening or randomization.
• Patient with an estimated glomerular filtration rate \< 30 mL/min/1.73 m2 or on dialysis.
• Patient with hepatic insufficiency classified as Child-Pugh B or C.
• Patient has medical history of disease(s) affecting the blood-brain-barrier, e.g., stroke within 6 months or multiple sclerosis.
• Patient has medical history of bleeding disorders or has thrombocytopenia (platelets \< 100,000/μL).
• Patient has poorly controlled diabetes as determined by the Investigator.
• Patient has a history or presence of any of the following cardiac conditions: known structural cardiac abnormalities beyond HF, family history of long QT syndrome, cardiac syncope, or recurrent, idiopathic syncope.
• Any clinically significant abnormalities, at the discretion of the Investigator, in rhythm, conduction, or morphology of resting ECG that pose an additional safety risk to patients.
• Patient with active "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)" infection confirmed as per the local testing guidelines at screening.
• Patient is not to be enrolled into the study if they received any prohibited therapy within 3 months of screening.

Sponsors & Collaborators

• Cardior Pharmaceuticals GmbH: lead

Study Sites (49)

Institut klinicke a experimentalni mediciny

Prague, Czechia

Location

Všeobecná fakultní nemocnice v Praze

Prague, Czechia

Location

St. Marien-Krankenhaus Ahaus

Ahaus, Germany

Location

Herzzentrum Dresden Universitätsklinik

Dresden, Germany

Location

Helios Klinikum Erfurt

Erfurt, Germany

Location

Universitätsmedizin Göttingen

Göttingen, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Germany

Location

"Alexandra" General Hospital of Athens

Athens, Greece

Location

"Attikon" General University Hospital

Athens, Greece

Location

General University Hospital of Patras "Panagia i Voitheia"

Pátrai, Greece

Location

Semmelweis University

Budapest, Hungary

Location

Jeroen Bosch Ziekenhuis (JBZ) (Hieronymus Bosch Hospital) - locatie Den Bosch

's-Hertogenbosch, Netherlands

Location

Deventer Ziekenhuis

Deventer, Netherlands

Location

Slingeland Ziekenhuis

Doetinchem, Netherlands

Location

Gelderse Vallei Ziekenhuis

Ede, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

St. Jansdal Ziekenhuis

Lelystad, Netherlands

Location

Erasmus University Medical Center

Rotterdam, Netherlands

Location

Ikazia Ziekenhuis

Rotterdam, Netherlands

Location

D & A Research B.V.

Sneek, Netherlands

Location

Gelre Ziekenhuizen

Zutphen, Netherlands

Location

Polsko Amerykanskie Kliniki Serca

Kędzierzyn-Koźle, Poland

Location

Specjalistyczna Poradnia Kardiologiczna i Nadcisnienia Tetniczego

Kielce, Poland

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, Poland

Location

Gabinet Internistyczno-Kardiologiczny Jacek Nowak

Libiąż, Poland

Location

NZOZ SALUS JZ Peruga

Lodz, Poland

Location

One wojskowy Szpital Kliniczny w Lublinie

Lublin, Poland

Location

Medicome Sp. z o.o.

Oświęcim, Poland

Location

Wojewódzki Szpital im. Sw. Ojca Pio w Przemyslu

Przemyśl, Poland

Location

NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog

Sopot, Poland

Location

Wojewodzki Szpital Zespolony

Torun, Poland

Location

Spec.Szpital im.dr Sokolowskiego

Wałbrzych, Poland

Location

Investigational Site

Wroclaw, Poland

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Spain

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, Spain

Location

Hospital Universitario San Cecilio

Granada, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Universitario de Sabadell

Sabadell, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, Spain

Location

Complejo Hospitalario Universitario de Vigo

Vigo, Spain

Location

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

Wycombe Hospital

High Wycombe, United Kingdom

Location

Richmond Pharmacology Limited

London, United Kingdom

Location

South Tees Hospital NHS Foundation Trust

Middlesbrough, United Kingdom

Location

MeSH Terms

Conditions

Myocardial Infarction; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Johann Bauersachs, Prof. Dr.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy staff is unblinded. They will hand-over prepared investigational medicinal product (IMP) in light-protected syringe.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 28, 2022
• Study Start: July 7, 2022
• Primary Completion: September 26, 2024
• Study Completion: March 17, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8); ES (9); GB (4); PL (12); HU (1); GR (3); CZ (2); NL (10)