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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06112327
• Other study ID #: LTF-001
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: December 2038

Study information

• Verified date: October 2023
• Source: Verve Therapeutics, Inc.
• Contact: Clinical Operations at Verve Therapeutics
• Phone: +1 781-970-6833
• Email: LTF001[@]vervetx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 2038
• Est. primary completion date: December 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Heterozygous Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Locations

Country	Name	City	State
New Zealand	Clinical Study Center	Auckland
New Zealand	Clinical Study Center	Christchurch
United Kingdom	Clinical Study Center	London

Sponsors (1)

Lead Sponsor	Collaborator
Verve Therapeutics, Inc.

Countries where clinical trial is conducted

New Zealand,  United Kingdom, 

Outcome

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