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

Sponsor

Verve Therapeutics, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06112327

Collaborator

(none)

Enrollment

Locations

176

Anticipated Duration (Months)

14.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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, including time in both the interventional study and study LTF-001.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerotic Cardiovascular Disease Heterozygous Familial Hypercholesterolemia Hypercholesterolemia

Study Design

Study Type:

Observational

Anticipated Enrollment :

44 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2024

Anticipated Primary Completion Date :

Dec 1, 2038

Anticipated Study Completion Date :

Dec 1, 2038

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Percent and absolute change from baseline of lipid concentrations and 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 lipid concentrations (including LDL-C) and target biomarkers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

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

Exclusion Criteria: N/A