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NCT06164730 Clinical Trial

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

Heterozygous Familial Hypercholesterolemia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06164730
Other study ID # VT-10201
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date May 2024
Est. completion date August 2026

Study information
Verified date December 2023
Source Verve Therapeutics, Inc.
Contact Clinical Development
Phone 781-970-6833
Email verve102clinicaltrials@vervetx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 36
Est. completion date August 2026
Est. primary completion date August 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Diagnosis of HeFH or premature CAD - Females of non-childbearing potential or males Exclusion Criteria: - Homozygous familial hypercholesterolemia - Active or history of chronic liver disease - Current treatment with PCSK9 inhibitor or prior treatment within specified timeframe - Clinically significant or abnormal laboratory values as defined by the protocol

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• VERVE-102
Intravenous (IV) infusion

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Verve Therapeutics, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) up to Day 365
Secondary Evaluation of maximum observed concentration (Cmax) up to Day 365
Secondary Evaluation of time to maximum observed concentration (tmax) up to Day 365
Secondary Evaluation of terminal elimination half-life (t1/2) up to Day 365
Secondary Percent and absolute change from baseline in plasma PCSK9 concentration up to Day 365
Secondary Percent and absolute change from baseline in LDL-C up to Day 365
See also
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Active, not recruiting NCT05398029 - A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease Phase 1
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Completed NCT05325203 - A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH). Phase 3
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