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A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease

RECRUITINGPhase 1Sponsored by Verve Therapeutics, Inc.
Actively Recruiting
PhasePhase 1
SponsorVerve Therapeutics, Inc.
Started2024-04-30
Est. completion2026-08
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
Locations7 sites

Summary

VT-10201 is an Open-label, Phase 1b, Single-ascending Dose Study That Will Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia (HeFH) or Premature Coronary Artery Disease (CAD) Who Require Additional Lowering of LDL-C. VERVE-102 Uses Base-editing Technology Designed to Disrupt the Expression of the PCSK9 Gene in the Liver and Lower Circulating PCSK9 and LDL-C. This Study is Designed to Determine the Safety and Pharmacodynamic Profile of VERVE-102 in This Patient Population.

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
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

Conditions3

Heart DiseaseHeterozygous Familial HypercholesterolemiaPremature Coronary Heart Disease

Interventions1

Locations7 sites

Clinical Study Center
Dothan, Alabama, 36305
Clinical Study Center
Pomona, California, 91768
Clinical Study Center
Boca Raton, Florida, 33434
Clinical Study Center
Winter Park, Florida, 32789
Clinical Study Center
High Point, North Carolina, 27260

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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