ClinicalTrials.gg
RecruitingNCT07606274Updated Aug 7, 2026

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

A Phase 1/2 interventional study of NVC-001 - Low Dose and NVC-001 - Intermediate Dose in LMNA-Related Dilated Cardiomyopathy, sponsored by Nuevocor Pte. Ltd.. Recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Nuevocor Pte. Ltd. · Phase 1/2, Interventional, and Other

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
21
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 64 studies in Cardiomyopathy, Dilated with a site in United States — 14 open to participants now, 20 under way, 2 of them phase 3. Cardiomyopathy, Dilated · United States.

Planned enrollment
27th of 42
21 · median 37
Started
2026
with 4 others
Phase 1/2
8 of 64
3 open now
Primary completion
2030-03
later than 14 of 19 live
Registered
63rd of 64
by date

Among the 64 studies in Cardiomyopathy, Dilated with a site in United States, this one is the 27th largest by planned enrollment of the 42 interventional ones, is one of 5 that started in 2026, is one of 8 in phase 1/2, reaches primary completion later than 14 of the 19 other live ones, and was the 63rd registered.

By phase

64 studies; the count open now beside each. This study's row is marked.

Observational21 · 6 open
No phase15 · 1 open
Phase 1/2this study8 · 3 open
Phase 28 · 0 open
Phase 15 · 2 open
Phase 34 · 1 open
Phase 42 · 0 open
Phase 2/31 · 1 open

By the year they started

First in 1992; this study’s year is marked. 5 started in 2026.

Size and results

Median enrollment 37 across the 42 interventional studies, 166 across the 20 observational. Of the 38 that completed or were terminated, 16 (42%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 64 studies in Cardiomyopathy, Dilated with a site in United States, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • LMNA-Related Dilated Cardiomyopathy

Keywords

  • LMNA-related DCM
  • Dilated Cardiomyopathy
  • DCM
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Adult ≥18 years old, able to provide
  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. Functional Class I, II, or III
  5. >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/ 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
21 participants (estimated)

Study arms

  • Experimental
    SAD low dose

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

    Genetic: NVC-001 - Low Dose

  • Experimental
    SAD medium dose

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

    Genetic: NVC-001 - Intermediate Dose

  • Experimental
    SAD high dose

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

    Genetic: NVC-001 - High Dose

Interventions

  • GeneticNVC-001 - Low Dose

    Solution for intravenous infusion

  • GeneticNVC-001 - Intermediate Dose

    Solution for intravenous infusion

  • GeneticNVC-001 - High Dose

    Solution for intravenous infusion

06

What researchers measure

Primary outcomes

  1. Safety: Frequency, severity, and relatedness of treatment-emergent adverse events (TEAEs)

    Time frame: At week 26

Secondary outcomes

  1. Change in echocardiographic parameters

    Time frame: Up to 104 weeks

  2. Change from baseline in arrhythmias

    Time frame: Up to 104 weeks

  3. Change in exercise capacity

    Time frame: Up to 104 weeks

  4. Change from baseline in quality of life (QoL)

    Time frame: Up to 104 weeks

  5. Incidence of clinical events

    Time frame: Up to week 104

07

Study locations

3 of 8 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for Mar 2030, 45 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2026
First posted
May 26, 2026
StartActual
Jun 16, 2026
Primary completionEst.
Mar 2030
CompletionEst.
Mar 2030
Last update
Aug 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07606274
Lead sponsor
Nuevocor Pte. Ltd.
Responsible party
Sponsor
First posted
May 26, 2026
Start date
Jun 16, 2026
Primary completion
Mar 2030 (estimated)
Completion
Mar 2030 (estimated)
Last update
Aug 7, 2026

Study contacts

Monica Shah, MD
study director · Nuevocor Pte. Ltd.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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