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

• Conditions: Hypercholesterolemia; Atherosclerotic Cardiovascular Disease; Heterozygous Familial Hypercholesterolemia

• Registration Number: NCT06112327
• Lead Sponsor: Verve Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-01
• Study Start: 2024-06-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2039-10
• Study Completion: 2039-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Not provided

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Exclusion Criteria

N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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).

Trial Locations

Locations (1)

Clinical Study Center; 🇬🇧 London, United Kingdom