A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease
About the study
VT-1001 is an open-label, phase 1b, single-ascending dose study that will evaluate the safety of VERVE-101 administered to patients with heterozygous familial hypercholesterolemia (HeFH), atherosclerotic cardiovascular disease (ASCVD), and uncontrolled hypercholesterolemia. VERVE-101 uses base-editing technology designed to disrupt the expression of the PCSK9 gene in the liver and lower circulating PCSK9 and LDL-C in patients with established ASCVD due to HeFH. This study is designed to determine the safety and pharmacodynamic profile of VERVE-101 in this patient population.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Male and/or female participants 18 up to 75 years at time of signing of informed consent
- Female participants not of child-bearing potential
- Diagnosis of HeFH
- Established ASCVD
EXCLUSION CRITERIA
Exclusion Criteria:
- Active or history of chronic liver disease
- Current treatment with PCSK9 monoclonal antibody therapy
- Current or past treatment with inclisiran
- Clinically significant or abnormal laboratory values as defined by the protocol
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Heterozygous Familial Hypercholesterolemia,Atherosclerotic Cardiovascular Disease,Hypercholesterolemia
Age (in years)
18 - 75
Phase
Phase 1
Participants needed
44
Est. Completion Date
Dec 31, 2024
Treatment type
Interventional
Sponsor
Verve Therapeutics, Inc.
ClinicalTrials.gov identifier
NCT05398029
Study number
VT-1001
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