Trials / Completed
CompletedNCT05398029
A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Verve Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Heterozygous Familial Hypercholesterolemia
- Atherosclerotic Cardiovascular Disease
- Hypercholesterolemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VERVE-101 | Intravenous (IV) infusion. |
Timeline
- Start date
- 2022-07-05
- Primary completion
- 2025-02-14
- Completion
- 2025-02-14
- First posted
- 2022-05-31
- Last updated
- 2025-05-08
Locations
3 sites across 2 countries: New Zealand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05398029. Inclusion in this directory is not an endorsement.