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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06112327
Recruitment Status : Not yet recruiting
First Posted : November 1, 2023
Last Update Posted : November 1, 2023
Sponsor:
Information provided by (Responsible Party):
Verve Therapeutics, Inc.

Study Description
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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, including time in both the interventional study and study LTF-001.

Condition or disease
Atherosclerotic Cardiovascular Disease Heterozygous Familial Hypercholesterolemia Hypercholesterolemia

Study Design
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Study Type : Observational
Estimated Enrollment : 44 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-term Follow-up Study of Investigational Gene-editing Therapies in Participants With or at High Risk for Cardiovascular Disease
Estimated Study Start Date : April 2024
Estimated Primary Completion Date : December 2038
Estimated Study Completion Date : December 2038

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who received an investigational gene-editing therapy developed by the sponsor.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06112327


Contacts
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Contact: Clinical Operations at Verve Therapeutics +1 781-970-6833 LTF001@vervetx.com

Locations
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New Zealand
Clinical Study Center
Auckland, New Zealand
Clinical Study Center
Christchurch, New Zealand
United Kingdom
Clinical Study Center
London, United Kingdom
Sponsors and Collaborators
Verve Therapeutics, Inc.
More Information
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Responsible Party: Verve Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT06112327    
Other Study ID Numbers: LTF-001
First Posted: November 1, 2023    Key Record Dates
Last Update Posted: November 1, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Verve Therapeutics, Inc.:
LTF-001
Cardiovascular Disease
Gene Editing
Familial Hypercholesterolemia
Base Editing
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
 Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases