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

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.

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Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Heterozygous Familial Hypercholesterolemia Hypercholesterolemia Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Study Center, Auckland, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Time frame: 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 outcomes

Percent and absolute change from baseline of lipid concentrations over time after administration of a gene-editing therapy.

Time frame: 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.

Time frame: up to 15 years

Blood samples will be collected to assess percent change from baseline in target biomarkers.

Sponsors and collaborators

Lead sponsor

Verve Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2039
Study completion: 2039
First posted: Nov 1, 2023
Registry last updated: Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed