A Phase 1b Single Ascending Dose Study to Evaluate the Safety of VERVE-201 in Patients With Refractory Hyperlipidemia
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Refractory hypercholesterolemia
• Refractory hypertriglyceridemia
Locations
United States
Florida
Clinical Study Center
RECRUITING
Clearwater
Clinical Study Center
RECRUITING
Miami Lakes
Clinical Study Center
RECRUITING
Port Orange
New York
Clinical Study Center
RECRUITING
New York
Other Locations
Australia
Clinical Study Center
RECRUITING
Adelaide
Clinical Study Center
RECRUITING
Melbourne
Canada
Clinical Study Center
RECRUITING
Chicoutimi
Clinical Study Center
RECRUITING
Montreal
Clinical Study Center
RECRUITING
Toronto
Netherlands
Clinical Study Center
RECRUITING
Amsterdam
South Africa
Clinical Study Center
RECRUITING
Cape Town
Clinical Study Center
RECRUITING
Johannesburg
United Kingdom
Clinical Study Center
RECRUITING
Liverpool
Clinical Study Center
RECRUITING
London
Clinical Study Center
RECRUITING
Manchester
Clinical Study Center 2
RECRUITING
Manchester
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-10-30
Estimated Completion Date: 2027-12
Participants
Target number of participants: 36
Treatments
Experimental: Cohort 1: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-201.
Experimental: Cohort 2: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-201.
Experimental: Cohort 3: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-201.
Experimental: Cohort 4: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-201.
Experimental: Cohort 5: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-201.
Experimental: Cohort 6: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-201.
Related Therapeutic Areas
Sponsors
Leads: Verve Therapeutics, Inc.