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VERVE-101 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Part A: Single Ascending Dose Escalation/Adaptive Design | EXPERIMENTAL | Participants will receive a single dose of VERVE-101 in multiple dose-escalation cohorts. |
| Part B: Single Dose Expansion | EXPERIMENTAL | Participants will receive a single dose of VERVE-101 selected based on the doses studied in Part A. |
| Name | Type | Description |
|---|---|---|
| VERVE-101 | DRUG | Intravenous (IV) infusion. |
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 PCS...
VERVE-101 is an investigational gene editing medicine being developed by Verve Therapeutics for heterozygous familial hypercholesterolemia, a genetic condition that causes high LDL cholesterol. It is designed as a one-time treatment and has been studied in a Phase 1 clinical trial in patients with familial hypercholesterolemia and cardiovascular disease.
VERVE-101 targets PCSK9, a gene that regulates LDL cholesterol levels. By editing the PCSK9 gene, the therapy aims to reduce LDL cholesterol in patients with heterozygous familial hypercholesterolemia. PCSK9 is a well-validated target for lowering cholesterol, and VERVE-101 is designed to provide a durable effect.
VERVE-101 is being developed by Verve Therapeutics, Inc., a biotechnology company focused on gene editing medicines for cardiovascular disease. Verve Therapeutics trades on the Nasdaq under the ticker symbol VERV.
VERVE-101 has completed a Phase 1 clinical trial. It is an investigational therapy and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial, NCT05398029, enrolled 13 patients with heterozygous familial hypercholesterolemia and cardiovascular disease in New Zealand and the United Kingdom.
VERVE-101 has been studied in one clinical trial: NCT05398029, titled "A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease." This Phase 1 trial is completed and enrolled 13 patients across New Zealand and the United Kingdom. It was a controlled study in adults aged 18 years and older.