ClinicalTrials.gg
Enrolling by invitationNCT06112327Updated Apr 8, 2026

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

An observational study in Atherosclerotic Cardiovascular Disease, Heterozygous Familial Hypercholesterolemia and Hypercholesterolemia, sponsored by Verve Therapeutics, Inc.. Enrolling by invitation at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Verve Therapeutics, Inc. (part of Eli Lilly and Company) · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
116
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Atherosclerotic Cardiovascular Disease
  • Heterozygous Familial Hypercholesterolemia
  • Hypercholesterolemia

Keywords

  • LTF-001
  • Cardiovascular Disease
  • Gene Editing
  • Familial Hypercholesterolemia
  • Base Editing
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In context

Atherosclerosis

1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.

This study's planned enrollment of 116 is below the median of 250 across 527 observational studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Verve Therapeutics, Inc. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

First submitted before Verve Therapeutics, Inc. became part of Eli Lilly and Company.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility 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 for LTF-001.

Exclusion Criteria: N/A

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
116 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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.

    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.

    Time frame: up to 15 years

Secondary outcomes

  1. 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).

    Time frame: up to 15 years

  2. 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.

    Time frame: up to 15 years

07

Study locations

3 sites
  • Clinical Study Center
    Auckland, New Zealand
  • Clinical Study Center
    Christchurch, New Zealand
  • Clinical Study Center
    London, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Oct 2039, 184 months after the start.

Of 169 observational studies under Atherosclerosis, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 153. This study's planned 184 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2023
First posted
Nov 1, 2023
StartActual
Jun 9, 2024
Primary completionEst.
Oct 2039
CompletionEst.
Oct 2039
Last update
Apr 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06112327
Responsible party
Sponsor
First posted
Nov 1, 2023
Start date
Jun 9, 2024
Primary completion
Oct 2039 (estimated)
Completion
Oct 2039 (estimated)
Last update
Apr 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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