RecruitingPhase 1NCT06164730

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

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


Sponsor

Verve Therapeutics, Inc.

Enrollment

85 participants

Start Date

Apr 30, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

  • Diagnosis of HeFH or premature CAD

Exclusion Criteria4

  • 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

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Interventions

DRUGVERVE-102

Intravenous (IV) infusion


Locations(22)

Clinical Study Center

Dothan, Alabama, United States

Clinical Study Center

Pomona, California, United States

Clinical Study Center

Boca Raton, Florida, United States

Clinical Study Center

Jacksonville, Florida, United States

Clinical Study Center

Winter Park, Florida, United States

Clinical Study Center

High Point, North Carolina, United States

Clinical Study Center

DeSoto, Texas, United States

Clinical Study Center

Renton, Washington, United States

Clinical Study Center

Adelaide, Australia

Clinical Study Center

Melbourne, Australia

Clinical Study Center

Sydney, Australia

Clinical Study Center

Chicoutimi, Canada

Clinical Study Center

Montreal, Canada

Clinical Study Center

Toronto, Canada

Clinical Study Center

Vancouver, Canada

Clinical Study Center

Rehovot, Israel

Clinical Study Center

Christchurch, New Zealand

Clinical Study Center

Birmingham, United Kingdom

Clinical Study Center

Edinburgh, United Kingdom

Clinical Study Center

London, United Kingdom

Clinical Study Center

Manchester, United Kingdom

Clinical Study Center

Nottingham, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06164730


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