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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 Hyperlipidemia.
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) and triglycerides. This study is designed to determine the safety and pharmacodynamic profile of VERVE-201 in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Single Ascending Dose Escalation | Experimental | Participants will receive a single dose of VERVE-201. |
|
| Cohort 2: Single Ascending Dose Escalation | Experimental | Participants will receive a single dose of VERVE-201. |
|
| Cohort 3: Single Ascending Dose Escalation | Experimental | Participants will receive a single dose of VERVE-201. |
|
| Cohort 4: Single Ascending Dose Escalation | Experimental | Participants will receive a single dose of VERVE-201. |
|
| Cohort 5: Single Ascending Dose Escalation | Experimental | Participants will receive a single dose of VERVE-201. |
|
| Cohort 6: Single Ascending Dose Escalation | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VERVE-201 | Drug | Intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Up to Day 365 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of maximum observed concentration (Cmax) | Up to Day 365 | |
| Evaluation of time to maximum observed concentration (tmax) | Up to Day 365 | |
| Evaluation of terminal elimination half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development | Contact | 781-970-6833 | verve201clinicaltrials@lists.lilly.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Center | Recruiting | Adelaide | Australia | |||
| Clinical Study Center |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D015228 | Hypertriglyceridemia |
| D006949 | Hyperlipidemias |
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Single ascending dose escalation/adaptive design
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Participants will receive a single dose of VERVE-201.
|
| Up to Day 365 |
| Percent and absolute change from baseline in serum ANGPTL3 concentration | Up to Day 365 |
| Percent and absolute change from baseline in serum LDL-C | Up to Day 365 |
| Percent and absolute change from baseline in serum triglycerides | Up to Day 365 |
| Recruiting |
| Melbourne |
| Australia |
| Clinical Study Center | Recruiting | Chicoutimi | Canada |
| Clinical Study Center | Recruiting | Montreal | Canada |
| Clinical Study Center | Recruiting | Toronto | Canada |
| Clinical Study Center | Recruiting | Cape Town | South Africa |
| Clinical Study Center | Recruiting | Johannesburg | South Africa |
| Clinical Study Center | Recruiting | Liverpool | United Kingdom |
| Clinical Study Center | Recruiting | London | United Kingdom |
| Clinical Study Center | Recruiting | Manchester | United Kingdom |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |