Long-term Follow-up of Participants Dosed With an Investigational Gene Editing Therapy for Cardiovascular Disease

Long-term Follow-up Study of Investigational Gene-editing Therapies in Participants With or at High Risk for Cardiovascular Disease

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06112327

Enrollment

116

Registered

2023-11-01

Start date

2024-06-09

Completion date

2039-10-01

Last updated

2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic Cardiovascular Disease, Heterozygous Familial Hypercholesterolemia, Hypercholesterolemia

Keywords

LTF-001, Cardiovascular Disease, Gene Editing, Familial Hypercholesterolemia, Base Editing

Brief summary

LTF-001 is a long-term follow-up study of participants who received an investigational gene-editing therapy developed by the sponsor to evaluate the long-term effects of the investigational therapy. Participants will be followed for a total of 15 years after the first administration of the gene-editing therapy.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. A participant has completed or discontinued from a Verve sponsored clinical study in which they received at least one dose of study drug. 2. A participant has provided informed consent for LTF-001.

Exclusion criteria

N/A

Design outcomes

Primary

Measure	Time frame	Description
Incidence of treatment-related adverse events (AEs), serious adverse events (SAEs) and other events of interest using CTCAE 5.0 to assess the long-term safety of gene-editing therapies.	up to 15 years	To assess the long-term safety of gene-editing therapies, the following will be assessed: Incidence of treatment-related adverse events (AEs), serious adverse events (SAEs) and any CTCAE grade 3 or higher AEs.

Secondary

Measure	Time frame	Description
Percent and absolute change from baseline of lipid concentrations over time after administration of a gene-editing therapy.	up to 15 years	Blood samples will be collected to assess percent change from baseline in lipid concentrations (including LDL-C).
Percent and absolute change from baseline of target biomarkers over time after administration of a gene-editing therapy.	up to 15 years	Blood samples will be collected to assess percent change from baseline in target biomarkers.

Countries

New Zealand, United Kingdom

Outcome results