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

NCT ID: NCT06112327

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-09

Study Completion Date

2039-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atherosclerotic Cardiovascular Disease Heterozygous Familial Hypercholesterolemia Hypercholesterolemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Verve Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Study Center

Auckland, , New Zealand

Site Status

Clinical Study Center

Christchurch, , New Zealand

Site Status

Clinical Study Center

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

New Zealand United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LTF-001

Identifier Type: -

Identifier Source: org_study_id