RecruitingPhase 1NCT06451770

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

A Phase 1b Single Ascending Dose Study to Evaluate the Safety of VERVE-201 in Patients With Refractory Hyperlipidemia


Sponsor

Verve Therapeutics, Inc.

Enrollment

36 participants

Start Date

Oct 30, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

  • Refractory hypercholesterolemia
  • Refractory hypertriglyceridemia

Exclusion Criteria3

  • 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

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Interventions

DRUGVERVE-201

Intravenous (IV) infusion


Locations(10)

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

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

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06451770


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