VT-10201 - Open-label, phase 1b, single-ascending dose study to evaluate the safety of VERVE-102
Research type
Research Study
Full title
Open-label, phase 1b, single ascending dose study to evaluate the safety of VERVE-102 administered to patients with heterozygous familial hypercholesterolemia or premature coronary artery disease who require additional lowering of low-density lipoprotein cholesterol
IRAS ID
1008942
Contact name
Matthew Schmidt
Contact email
Sponsor organisation
Verve Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
Verve Therapeutics is funding this research to learn more about VERVE-102 to see if it is safe and whether it lowers low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH) or premature coronary artery disease (CAD). Both diseases may cause extremely high levels of (LDL-C) in the blood. LDL-C is a type of cholesterol or “fat” that is present in the blood and is sometimes referred to as “bad” cholesterol. High LDL-C can cause a narrowing of the arteries and increase the risk of suffering a heart attack or stroke. VERVE-102 is designed to lower the levels of LDL-C in the blood. It does this by making a change to the DNA in a gene called “PCSK9” to stop it from working. Stopping the PCSK9 gene from working is known to lower LDL-C levels. VERVE-102 is an investigational medication and is not yet approved for use by any health authorities. This is the first time VERVE-102 is being tested in humans. The goal of this study is to determine whether VERVE-102 is safe and whether it lowers blood levels of LDL-C. Participants will be in the study for approximately one year, but will be asked to participate in a long-term follow-up study for up to 15 years as well. The study is planned to be conducted at research centers in North America, UK, and Australia/New Zealand.
REC name
North East - York Research Ethics Committee
REC reference
24/NE/0021
Date of REC Opinion
13 Mar 2024
REC opinion
Further Information Favourable Opinion