NCT06164730

A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Verve Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heterozygous Familial Hypercholesterolemia
• Premature Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	VERVE-102	Intravenous (IV) infusion

Timeline

• Start date: 2024-04-30
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2023-12-11
• Last updated: 2026-04-01

Locations

22 sites across 6 countries: United States, Australia, Canada, Israel, New Zealand, United Kingdom

Regulatory

• FDA-regulated drug study