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

October 31, 2023 updated by: Verve Therapeutics, Inc.

Long-term Follow-up Study of Investigational Gene-editing Therapies in Participants With or at High Risk 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, including time in both the interventional study and study LTF-001.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Clinical Operations at Verve Therapeutics
  • Phone Number: +1 781-970-6833
  • Email: LTF001@vervetx.com

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • Clinical Study Center
      • Christchurch, New Zealand
        • Clinical Study Center
  • United Kingdom
      • London, United Kingdom
        • Clinical Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who received an investigational gene-editing therapy developed by the sponsor.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent and absolute change from baseline of lipid concentrations and 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 lipid concentrations (including LDL-C) and target biomarkers.
up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Verve Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 1, 2038

Study Completion (Estimated)

December 1, 2038

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 31, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTF-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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