Clinical trial Recruiting at 27 sites Phase 1 Interventional Ages 18 to 70

Evaluating VERVE-102 for lowering cholesterol in specific heart disease patients

Official title: Open-label, Phase 1b, Single Ascending Dose Study to Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia or Premature Coronary Artery Disease Who Require Additional Lowering of Low-density Lipoprotein Cholesterol

Run by Verve Therapeutics, Inc. · NCT06164730 · Data updated 2026-11-12

This study is testing a new gene-editing treatment called VERVE-102 to see if it can lower cholesterol levels in people with certain heart conditions.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment85 (estimated)
SponsorVerve Therapeutics, Inc.
Industry-sponsored
Locations27 sites (Dothan, Alabama and 26 other locations)
StatusRecruiting
StartedApril 30, 2024
Main results expectedOctober 2026
Study endsOctober 2027
Registry record updatedSeptember 2, 2026
Trial IDNCT06164730 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals diagnosed with heterozygous familial hypercholesterolemia or premature coronary artery disease who need further LDL-C reduction.

Probably not a fit

Patients with homozygous familial hypercholesterolemia or those with active liver disease may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and pharmacodynamic profile of VERVE-102, a gene-editing therapy designed to lower LDL cholesterol levels by disrupting the PCSK9 gene in the liver. It targets patients with heterozygous familial hypercholesterolemia or premature coronary artery disease who require additional LDL-C lowering. The study is open-label and employs a single-ascending dose approach to assess the effects of VERVE-102. Participants will be monitored for safety and efficacy throughout the trial.

Why it matters

Potential benefit: If successful, this treatment could significantly lower cholesterol levels and reduce the risk of heart disease in patients with specific genetic predispositions.

How similar studies have gone: Other studies utilizing gene editing technologies for cholesterol management have shown promise, indicating potential for success in this novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosis of HeFH or premature CAD

Exclusion Criteria:

* Homozygous familial hypercholesterolemia
* Active or history of chronic liver disease
* Current treatment with PCSK9 inhibitor or prior treatment within specified timeframe
* Clinically significant or abnormal laboratory values as defined by the protocol

Where it's running

  • Clinical Study Center
    Dothan, Alabama, United States
    Recruiting
  • Clinical Study Center
    Pomona, California, United States
    Recruiting
  • Clinical Study Center
    Boca Raton, Florida, United States
    Recruiting
  • Clinical Study Center
    Jacksonville, Florida, United States
    Recruiting
  • Clinical Study Center
    Winter Park, Florida, United States
    Recruiting
  • Clinical Study Center
    Indianapolis, Indiana, United States
    Recruiting
Show 21 more locations
  • Clinical Study Center
    High Point, North Carolina, United States
    Recruiting
  • Clinical Study Center
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Clinical Study Center
    DeSoto, Texas, United States
    Recruiting
  • Clinical Study Center
    Renton, Washington, United States
    Recruiting
  • Clinical Study Center
    Adelaide, Australia
    Recruiting
  • Clinical Study Center
    Melbourne, Australia
    Recruiting
  • Clinical Study Center
    Sydney, Australia
    Recruiting
  • Clinical Study Center
    Chicoutimi, Canada
    Recruiting
  • Clinical Study Center
    Hamilton, Canada
    Recruiting
  • Clinical Study Center
    Montreal, Canada
    Recruiting
  • Clinical Study Center
    Québec, Canada
    Recruiting
  • Clinical Study Center
    Toronto, Canada
    Recruiting
  • Clinical Study Center
    Vancouver, Canada
    Recruiting
  • Clinical Study Center
    Rehovot, Israel
    Recruiting
  • Clinical Study Center
    Christchurch, New Zealand
    Recruiting
  • Clinical Study Center
    Birmingham, United Kingdom
    Recruiting
  • Clinical Study Center
    Cambridge, United Kingdom
    Recruiting
  • Clinical Study Center
    Edinburgh, United Kingdom
    Recruiting
  • Clinical Study Center
    London, United Kingdom
    Recruiting
  • Clinical Study Center
    Manchester, United Kingdom
    Recruiting
  • Clinical Study Center
    Nottingham, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • AI-guided post-discharge care for premature coronary artery disease

    This trial will test whether an AI-powered app and stratified management system can lower deaths, heart attacks, strokes, and rehospitalizations and improve risk-factor control in adults aged 18–45 with premature coronary artery disease.

    Recruiting China National Center for Cardiovascular Diseases · Hefei, Anhui and 15 other locations · NCT07031531

  • Predicting future heart problems in young adults with premature coronary artery disease (MAP-CHD)

    This project will follow Chinese adults under 45 with premature coronary artery disease to see if clinical features and blood tests can predict future adverse heart events.

    Recruiting China National Center for Cardiovascular Diseases · Beijing · NCT07004452

  • Evaluating HST101 for lowering cholesterol in Chinese patients

    This study is testing if a new drug called HST101 can lower cholesterol levels in Chinese patients who have high cholesterol and are at risk for heart disease.

    Recruiting at 17 sites Phase 3 Hasten Biopharmaceutical Co., Ltd. · Beijing, Beijing Municipality and 17 other locations · NCT06568471

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.