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

Part of paid clinical trials in Clearwater, Florida.

Sponsor
Verve Therapeutics, Inc.
Study ID
NCT06451770
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • VERVE-201 — DRUG
    Intravenous (IV) infusion

Study Details

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.

Key Dates

First listed
Jun 11, 2024
Start date
Oct 30, 2024
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Single Ascending Dose Escalation
    Participants will receive a single dose of VERVE-201.
  • Experimental: Cohort 2: Single Ascending Dose Escalation
    Participants will receive a single dose of VERVE-201.
  • Experimental: Cohort 3: Single Ascending Dose Escalation
    Participants will receive a single dose of VERVE-201.
  • Experimental: Cohort 4: Single Ascending Dose Escalation
    Participants will receive a single dose of VERVE-201.
  • Experimental: Cohort 5: Single Ascending Dose Escalation
    Participants will receive a single dose of VERVE-201.
  • Experimental: Cohort 6: Single Ascending Dose Escalation
    Participants will receive a single dose of VERVE-201.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: Up to Day 365 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (4)

FacilityCityStateZIPSite coordinators
Clinical Study CenterClearwaterFlorida33756-
Clinical Study CenterMiami LakesFlorida33016-
Clinical Study CenterPort OrangeFlorida32127-
Clinical Study CenterNew YorkNew York10029-

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