Recruiting
Phase 1
Phase 2

NVC-001

Sponsor:

Nuevocor Pte. Ltd.

Code:

NCT07606274

Conditions

LMNA-Related Dilated Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NVC-001 - Low Dose

NVC-001 - Intermediate Dose

NVC-001 - High Dose

Study Details

Brief 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.

Conditions

LMNA-Related Dilated Cardiomyopathy

Study ID

NCT07606274

Start date

Jun 16, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

21 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: SAD low dose

Single Ascending Dose (SAD): participants will receive low dose of NVC-001

experimental: SAD medium dose

Single Ascending Dose (SAD): participants will receive medium dose of NVC-001

experimental: SAD high dose

Single Ascending Dose (SAD): participants will receive high dose of NVC-001

Interventions

NVC-001 - Low Dose

Solution for intravenous infusion

NVC-001 - Intermediate Dose

Solution for intravenous infusion

NVC-001 - High Dose

Solution for intravenous infusion

Primary outcome measure

  • Safety: Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs) [ Time Frame: At week 26 ]

Central Contacts and Locations

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Nuevocor Clinical Trial Team

310-248-8300info@nuevocor.com

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Nuevocor Clinical Trial Team

507-422-5433info@nuevocor.com

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Nuevocor Clinical Trial Team

281-222-9983info@nuevocor.com

More Information

Sponsor

Nuevocor Pte. Ltd.

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • LMNA-related DCM
  • Dilated Cardiomyopathy
  • DCM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nuevocor Pte. Ltd. on 2026-08-07.