NCT06451770PHASE1Recruiting

Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia

Verve Therapeutics, Inc.

Start Date

10/30/2024

Completion Date

12/1/2027

Summary

VT-20101 is an Open-label, Phase 1b, Single-ascending dose study that will evaluate the safety of VERVE-201 administered to patients with Refractory Hyperlipidemia. VERVE-201 uses base-editing technology designed to inactivate the expression of the ANGPTL3 gene in the liver and lower circulating low-density lipoprotein cholesterol (LDL-C) and triglycerides. This study is designed to determine the safety and pharmacodynamic profile of VERVE-201 in this patient population.

Eligibility Criteria

Age Range: 18 years to 70 years

Inclusion Criteria: * Refractory hypercholesterolemia * Refractory hypertriglyceridemia Exclusion Criteria: * Active or history of chronic liver disease * Current treatment with monoclonal antibody targeting ANGPTL3 or prior treatment within specified timeframe * Clinically significant or abnormal laboratory values as defined by the protocol

Interventions

DRUG

VERVE-201

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Conditions

HypercholesterolemiaHypertriglyceridemiaRefractory Hyperlipidemia

Locations

Clinical Study Center

Clearwater, Florida 33756

United States

Clinical Study Center

Miami Lakes, Florida 33016

United States

Clinical Study Center

Port Orange, Florida 32127

United States

Clinical Study Center

New York, New York 10029

United States

Clinical Study Center

Adelaide,

Australia

Clinical Study Center

Melbourne,

Australia

Clinical Study Center

Chicoutimi,

Canada

Clinical Study Center

Montreal,

Canada

Clinical Study Center

Toronto,

Canada

Clinical Study Center

Amsterdam,

Netherlands

Clinical Study Center

Cape Town,

South Africa

Clinical Study Center

Johannesburg,

South Africa

Clinical Study Center

Liverpool,

United Kingdom

Clinical Study Center

London,

United Kingdom

Clinical Study Center 2

Manchester,

United Kingdom

Clinical Study Center

Manchester,

United Kingdom