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

Verve Therapeutics

Status and phase

Enrolling

Phase 1

Conditions

Hypertriglyceridemia

Hypercholesterolemia

Refractory Hyperlipidemia

Treatments

Drug: VERVE-201

Study type

Interventional

Funder types

Industry

Identifiers

NCT06451770

VT-20101

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

36 participants in 6 patient groups

Cohort 1: Single Ascending Dose Escalation

Experimental group

Description: