VT-10201 is an Open-label, Phase 1b, Single-ascending Dose Study That Will Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia (HeFH) or Premature Coronary Artery Disease (CAD) Who Require Additional Lowering of LDL-C. VERVE-102 Uses Base-editing Technology Designed to Disrupt the Expression of the PCSK9 Gene in the Liver and Lower Circulating PCSK9 and LDL-C. This Study is Designed to Determine the Safety and Pharmacodynamic Profile of VERVE-102 in This Patient Population.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Intravenous (IV) infusion
Clinical Study Center
Dothan, Alabama, United States
RECRUITINGClinical Study Center
High Point, North Carolina, United States
RECRUITINGClinical Study Center
DeSoto, Texas, United States
RECRUITINGClinical Study Center
Renton, Washington, United States
RECRUITINGClinical Study Center
Adelaide, Australia
RECRUITINGClinical Study Center
Melbourne, Australia
RECRUITINGClinical Study Center
Sydney, Australia
ACTIVE_NOT_RECRUITINGClinical Study Center
Chicoutimi, Canada
RECRUITINGClinical Study Center
Montreal, Canada
RECRUITINGClinical Study Center
Toronto, Canada
RECRUITING...and 8 more locations
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: up to Day 365
Evaluation of maximum observed concentration (Cmax)
Time frame: up to Day 365
Evaluation of time to maximum observed concentration (tmax)
Time frame: up to Day 365
Evaluation of terminal elimination half-life (t1/2)
Time frame: up to Day 365
Percent and absolute change from baseline in plasma PCSK9 concentration
Time frame: up to Day 365
Percent and absolute change from baseline in LDL-C
Time frame: up to Day 365
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