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NCT06451770 Clinical Trial

Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia

Hypercholesterolemia Clinical Trial

Official title:
A Phase 1b Single Ascending Dose Study to Evaluate the Safety of VERVE-201 in Patients With Refractory Hyperlipidemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06451770
Other study ID # VT-20101
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date December 2024
Est. completion date March 2027

Study information
Verified date June 2024
Source Verve Therapeutics, Inc.
Contact Clinical Development
Phone 781-970-6833
Email verve201clinicaltrials@vervetx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 Hypercholesterolemia. 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). This study is designed to determine the safety and pharmacodynamic profile of VERVE-201 in this patient population.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 36
Est. completion date March 2027
Est. primary completion date March 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Refractory hypercholesterolemia - Females of non-childbearing potential or males Exclusion Criteria: - Active or history of chronic liver disease - Current treatment with monoclonal antibody targeting ANGPTL3 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-201
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 serum ANGPTL3 concentration Up to Day 365
Secondary Percent and absolute change from baseline in serum LDL-C Up to Day 365
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