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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 85 (estimated) |
| Sponsor | Verve Therapeutics, Inc. Industry-sponsored |
| Locations | 27 sites (Dothan, Alabama and 26 other locations) |
| Status | Recruiting |
| Started | April 30, 2024 |
| Main results expected | October 2026 |
| Study ends | October 2027 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT06164730 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
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Clinical Study Center
Dothan, Alabama, United States Recruiting -
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Pomona, California, United States Recruiting -
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Boca Raton, Florida, United States Recruiting -
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Jacksonville, Florida, United States Recruiting -
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Winter Park, Florida, United States Recruiting -
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Indianapolis, Indiana, United States Recruiting
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Nottingham, United Kingdom Recruiting
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 317-615-4559
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.
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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.
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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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.