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

NCT06451770 · tracked via the Priya Life Science UK tracker

Sponsor

Verve Therapeutics, Inc.

Phase

Phase 1

Started

2024-10-30

Last updated

2026-07-17

Condition(s) studied

HypercholesterolemiaHypertriglyceridemiaRefractory Hyperlipidemia

Investigational drug(s) / intervention(s)

VERVE-201

VERVE-201: Intravenous (IV) infusion

Study 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

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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

Primary outcome measure(s)

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) — Up to Day 365

Trial sites (16)

Facility	City	Region	Status
Clinical Study Center	Clearwater	Florida	Recruiting
Clinical Study Center	Miami Lakes	Florida	Recruiting
Clinical Study Center	Port Orange	Florida	Recruiting
Clinical Study Center	New York	New York	Recruiting
Clinical Study Center	Adelaide	Australia	Recruiting
Clinical Study Center	Melbourne	Australia	Recruiting
Clinical Study Center	Chicoutimi	Canada	Recruiting
Clinical Study Center	Montreal	Canada	Recruiting
Clinical Study Center	Toronto	Canada	Recruiting
Clinical Study Center	Amsterdam	Netherlands	Recruiting
Clinical Study Center	Cape Town	South Africa	Recruiting
Clinical Study Center	Johannesburg	South Africa	Recruiting
Clinical Study Center	Liverpool	United Kingdom	Recruiting
Clinical Study Center	London	United Kingdom	Recruiting
Clinical Study Center 2	Manchester	United Kingdom	Recruiting
Clinical Study Center	Manchester	United Kingdom	Recruiting

More Verve Therapeutics, Inc. trials in the UK

Long-term Follow-up of Participants Dosed With an Investigational Gene Editing Therapy for Cardiovascular Disease Enrolling by invitation

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

Other trials for the same condition

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia Recruiting

Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia Active, not recruiting

Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia Active, not recruiting

Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension Active, not recruiting

Long-term Follow-up of Participants Dosed With an Investigational Gene Editing Therapy for Cardiovascular Disease Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06451770 on ClinicalTrials.gov ↗ ← All trials in the UK