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
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Diagnosis of HeFH or premature CAD
• Females of non-childbearing potential or males
Locations
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
New Zealand
Clinical Study Center
RECRUITING
Christchurch
United Kingdom
Clinical Study Center
RECRUITING
London
Clinical Study Center
RECRUITING
Manchester
Contact Information
Primary
Clinical Development
verve102clinicaltrials@vervetx.com
781-970-6833
Time Frame
Start Date: 2024-04-30
Estimated Completion Date: 2026-08
Participants
Target number of participants: 36
Treatments
Experimental: Cohort 1: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-102.
Experimental: Cohort 2: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-102.
Experimental: Cohort 3: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-102.
Experimental: Cohort 4: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-102.
Related Therapeutic Areas
Sponsors
Leads: Verve Therapeutics, Inc.