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

NCT ID: NCT06451770

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia Hypertriglyceridemia Refractory Hyperlipidemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Single ascending dose escalation/adaptive design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-201.

Group Type EXPERIMENTAL

VERVE-201

Intervention Type DRUG

Intravenous (IV) infusion

Cohort 2: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-201.

Group Type EXPERIMENTAL

VERVE-201

Intervention Type DRUG

Intravenous (IV) infusion

Cohort 3: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-201.

Group Type EXPERIMENTAL

VERVE-201

Intervention Type DRUG

Intravenous (IV) infusion

Cohort 4: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-201.

Group Type EXPERIMENTAL

VERVE-201

Intervention Type DRUG

Intravenous (IV) infusion

Cohort 5: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-201.

Group Type EXPERIMENTAL

VERVE-201

Intervention Type DRUG

Intravenous (IV) infusion

Cohort 6: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-201.

Group Type EXPERIMENTAL

VERVE-201

Intervention Type DRUG

Intravenous (IV) infusion

Interventions

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VERVE-201

Intravenous (IV) infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Verve Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Study Center

Adelaide, , Australia

Site Status RECRUITING

Clinical Study Center

Melbourne, , Australia

Site Status RECRUITING

Clinical Study Center

Chicoutimi, , Canada

Site Status RECRUITING

Clinical Study Center

Montreal, , Canada

Site Status RECRUITING

Clinical Study Center

Toronto, , Canada

Site Status RECRUITING

Clinical Study Center

Cape Town, , South Africa

Site Status RECRUITING

Clinical Study Center

Johannesburg, , South Africa

Site Status RECRUITING

Clinical Study Center

Liverpool, , United Kingdom

Site Status RECRUITING

Clinical Study Center

London, , United Kingdom

Site Status RECRUITING

Clinical Study Center

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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Australia Canada South Africa United Kingdom

Central Contacts

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Clinical Development

Role: CONTACT

[email protected]
781-970-6833

Other Identifiers

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VT-20101

Identifier Type: -

Identifier Source: org_study_id

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