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NCT05398029 Clinical Trial

A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease

Hypercholesterolemia Clinical Trial

Official title:
Open-label, Phase 1b, Single-ascending Dose and Optional re Dosing Study to Evaluate the Safety of VERVE-101 Administered to Patients With Heterozygous Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, and Uncontrolled Hypercholesterolemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05398029
Other study ID # VT-1001
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date July 5, 2022
Est. completion date December 2024

Study information
Verified date April 2024
Source Verve Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

VT-1001 is an open-label, phase 1b, single-ascending dose study that will evaluate the safety of VERVE-101 administered to patients with heterozygous familial hypercholesterolemia (HeFH), atherosclerotic cardiovascular disease (ASCVD), and uncontrolled hypercholesterolemia. VERVE-101 uses base-editing technology designed to disrupt the expression of the PCSK9 gene in the liver and lower circulating PCSK9 and LDL-C in patients with established ASCVD due to HeFH. This study is designed to determine the safety and pharmacodynamic profile of VERVE-101 in this patient population.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 44
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Male and/or female participants 18 up to 75 years at time of signing of informed consent - Female participants not of child-bearing potential - Diagnosis of HeFH - Established ASCVD Exclusion Criteria: - Active or history of chronic liver disease - Current treatment with PCSK9 monoclonal antibody therapy - Current or past treatment with inclisiran - Clinically significant or abnormal laboratory values as defined by the protocol

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• VERVE-101
Intravenous (IV) infusion.

Locations
Country Name City State
New Zealand Clinical Study Center Auckland
New Zealand Clinical Study Center Christchurch
United Kingdom Clinical Study Center London

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

Countries where clinical trial is conducted

New Zealand,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Other Percent and absolute change from baseline in plasma PCSK9 concentration. up to Day 365
Other Percent and absolute change from baseline in LDL-C. up to Day 365
Primary Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs). 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
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