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NCT07606274PHASE1, PHASE2Recruiting

A Study With NVC-001 in Patients With LMNA-related Dilated Cardiomyopathy (SUNBEAM-LMNA)

Nuevocor Pte. Ltd.

Start Date

6/16/2026

Completion Date

3/1/2030

Summary

This study is designed to evaluate the safety and tolerability of NVC-001 in adults with LMNA-related dilated cardiomyopathy (LMNA-DCM). The study will also assess exploratory measures of efficacy.

Detailed Description

This is a Phase 1/2, open-label study of NVC-001 in adults with LMNA-related dilated cardiomyopathy (LMNA-DCM). The primary objective is to evaluate the safety and tolerability of NVC-001. Secondary and exploratory objectives include characterization of pharmacodynamic effects and assessment of preliminary efficacy.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: 1. Adult ≥18 years old, able to provide informed consent 2. Clinical diagnosis of LMNA-related dilated cardiomyopathy (DCM) with LV systolic dysfunction 3. Pathogenic or likely pathogenic LMNA mutation confirmed by a CLIA-certified/CAP-accredited laboratory 4. NYHA Functional Class I, II, or III 5. LVEF \>25% and ≤45% by echocardiography 6. Implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator )CRT-D) implanted \>3 months prior to consent Key Exclusion Criteria: 1. Any chronic medical condition that, in the Investigator's opinion, would compromise participant safety or compliance 2. Hospitalization as an inpatient for the following conditions within 3 months prior to signing the ICF: Heart failure, Persistent/refractory ventricular arrhythmia requiring external defibrillation, or multiple/recurrent cardioversion/defibrillation by ICD Indication for, or history of, LV assist device or cardiac transplantation due to end-stage cardiac dysfunction 3. Current or anticipated need for chronic IV inotropic therapy

Interventions

GENETIC

NVC-001 - Low Dose

GENETIC

NVC-001 - Intermediate Dose

GENETIC

NVC-001 - High Dose

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Conditions

LMNA-Related Dilated Cardiomyopathy

Locations

University of Alabama in Birmingham

Birmingham, Alabama 35294

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

The Christ Hospital

Cincinnati, Ohio 45219

United States

Houston Methodist Hospital

Houston, Texas 77030

United States