A Study With NVC-001 in Patients With LMNA-related Dilated Cardiomyopathy (SUNBEAM-LMNA)
Key facts
- Where
- Ann Arbor, Birmingham, Boston, Cincinnati, Columbus, Houston, Los Angeles, and Rochester, United StatesSee the 8 sites
- Phase
- Phase 1/2
Where in United States
- University of MichiganAnn Arbor, United StatesContact: Nuevocor Clinical Trial TeamNot yet recruiting
- University of Alabama in BirminghamBirmingham, United StatesContact: Nuevocor Clinical Trial TeamNot yet recruiting
- Brigham and Women's HospitalBoston, United StatesContact: Nuevocor Clinical Trial TeamNot yet recruiting
- The Christ HospitalCincinnati, United StatesContact: Nuevocor Clinical Trial TeamNot yet recruiting
- The Ohio State UniversityColumbus, United StatesContact: Nuevocor Clinical Trial TeamNot yet recruiting
- Houston Methodist HospitalHouston, United StatesContact: Nuevocor Clinical Trial TeamTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Nuevocor Clinical Trial TeamTaking people
- Mayo ClinicRochester, United StatesContact: Nuevocor Clinical Trial TeamTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Nuevocor Pte. Ltd.
- Trial code
- NCT07606274EU 2025-524828-21-00
- Record updated
- 7 August 2026
- Original description
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.Read full original descriptionShow less
A Phase 1/2, First-in-Human, Open-Label, Multicenter, Single-Dose Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of NVC-001, a Novel Adeno-Associated Virus (Serotype 9) Vector Expressing a Dominant Negative SUN1 Transgene, in Patients With LMNA-Related Dilated Cardiomyopathy (SUNBEAM-LMNA)
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.
Inclusion: Adult ≥18 years old, able to provide informed consent; Clinical diagnosis of LMNA-related dilated cardiomyopathy (DCM) with LV systolic dysfunction; Pathogenic or likely pathogenic LMNA mutation confirmed by a CLIA-certified/CAP-accredited laboratory; NYHA Functional Class I, II, or III; LVEF >25% and ≤45% by echocardiography; Implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator )CRT-D) implanted >3 months prior to consent.
Exclusion: 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; Current or anticipated need for chronic IV inotropic therapy; Any chronic medical condition that, in the Investigator's opinion, would compromise participant safety or compliance.