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NCT06164730PHASE1Recruiting

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

Verve Therapeutics, Inc.

Start Date

4/30/2024

Completion Date

8/1/2027

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 Criteria

Age Range: 18 years to 70 years

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

Interventions

DRUG

VERVE-102

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Conditions

Heterozygous Familial HypercholesterolemiaPremature Coronary Heart Disease

Locations

Clinical Study Center

Dothan, Alabama 36305

United States

Clinical Study Center

Pomona, California 91768

United States

Clinical Study Center

Boca Raton, Florida 33434

United States

Clinical Study Center

Jacksonville, Florida 32216

United States

Clinical Study Center

Winter Park, Florida 32789

United States

Clinical Study Center

High Point, North Carolina 27260

United States

Clinical Study Center

DeSoto, Texas 75115

United States

Clinical Study Center

Renton, Washington 98057

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

Hamilton,

Canada

Clinical Study Center

Montreal,

Canada

Clinical Study Center

Québec,

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