Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Recruiting · NCT06451770 · Interventional (participants receive a specific treatment) · Lead sponsor: Verve Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
VERVE-201
What this trial is 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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
16 locations listed across 2 US states.
- Clinical Study Center - Clearwater, Florida, United States
- Clinical Study Center - Miami Lakes, Florida, United States
- Clinical Study Center - Port Orange, Florida, United States
- Clinical Study Center - New York, New York, United States
- Clinical Study Center - Adelaide, Australia
- Clinical Study Center - Amsterdam, Netherlands
- Clinical Study Center - Cape Town, South Africa
- Clinical Study Center - Chicoutimi, Canada
- Clinical Study Center - Johannesburg, South Africa
- Clinical Study Center - Liverpool, United Kingdom
- Clinical Study Center - London, United Kingdom
- Clinical Study Center 2 - Manchester, United Kingdom
- Clinical Study Center - Manchester, United Kingdom
- Clinical Study Center - Melbourne, Australia
- Clinical Study Center - Montreal, Canada
- Clinical Study Center - Toronto, Canada