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

Conditions

• Heart Failure, Left Sided
• Myocardial Infarction, Acute

Eligibility Criteria

Sex

ALL

Age

30 Years - 80 Years

Healthy Volunteers

Not accepted

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.
• Placebo to CDR132L — DRUG
  Placebo to CDR132L

Study Details

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.

Key Dates

Start date

Jul 7, 2022

Status verified

Apr 2026

Primary completion

Sep 26, 2024

Completion

Mar 17, 2025

Study Design

Enrollment

294 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CDR132L 5 mg
  CDR132L 5 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57
• Experimental: CDR132L 10 mg
  CDR132L 10 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57
• Placebo Comparator: Placebo
  Placebo intravenous in single dose on Day 1, Day 29 and Day 57

Primary Outcome Measure

Echocardiography (ECHO) [ Time Frame: 6 months ]