Atherosclerotic Cardiovascular DiseaseNCT06112327
Long-term Follow-up of Participants Dosed With an Investigational Gene Editing Therapy for Cardiovascular Disease
An observational study of Atherosclerotic Cardiovascular Disease and Heterozygous Familial Hypercholesterolemia, run by Verve Therapeutics, Inc. at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease, Heterozygous Familial Hypercholesterolemia, Hypercholesterolemia
- How many people
- 116 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 9 Jun 2024to Oct 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who received an investigational gene-editing therapy developed by the sponsor.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
New Zealand2 sites
Clinical Study Center
Auckland
Clinical Study Center
Christchurch
About this study
Official title: 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.
- Conditions
- Atherosclerotic Cardiovascular Disease, Heterozygous Familial Hypercholesterolemia, Hypercholesterolemia
- Keywords
- LTF-001, Cardiovascular Disease, Gene Editing, Familial Hypercholesterolemia, Base Editing
- Medical subject headings
- Atherosclerosis, Hypercholesterolemia, Cardiovascular Diseases, Hyperlipoproteinemia Type II
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 15 years
Secondary outcomes (2)
Percent and absolute change from baseline of lipid concentrations 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).
Measured: up to 15 years
Percent and absolute change from baseline of target biomarkers over time after administration of a gene-editing therapy.
Blood samples will be collected to assess percent change from baseline in target biomarkers.
Measured: up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start9 Jun 2024
- Primary completionOct 2039 (estimated)
- Study completionOct 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verve Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112327
- Sponsor's protocol ID
- LTF-001
- Status last verified
- Apr 2026
- First submitted
- 12 Oct 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Study of Investigational Gene-editing Therapies in Participants With or at High Risk for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT06112327
- Acronym / sponsor ID
- LTF-001
- Conditions
- Atherosclerotic Cardiovascular Disease, Heterozygous Familial Hypercholesterolemia, Hypercholesterolemia
- Keywords
- LTF-001, Cardiovascular Disease, Gene Editing, Familial Hypercholesterolemia, Base Editing
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Verve Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2024 (actual)
- Primary completion
- Oct 2039 (estimated)
- Study completion
- Oct 2039 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who received an investigational gene-editing therapy developed by the sponsor.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 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
Percent and absolute change from baseline of target biomarkers over time after administration of a gene-editing therapy.
Time frame: up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Disease and Heterozygous Familial Hypercholesterolemia, run by Verve Therapeutics, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in New Zealand, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.