A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease
NCT ID: NCT05398029
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2022-07-05
2025-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: Single Ascending Dose Escalation/Adaptive Design
Participants will receive a single dose of VERVE-101 in multiple dose-escalation cohorts.
VERVE-101
Intravenous (IV) infusion.
Part B: Single Dose Expansion
Participants will receive a single dose of VERVE-101 selected based on the doses studied in Part A.
VERVE-101
Intravenous (IV) infusion.
Interventions
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VERVE-101
Intravenous (IV) infusion.
Eligibility Criteria
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Inclusion Criteria
* Female participants not of child-bearing potential
* Diagnosis of HeFH
* Established ASCVD
Exclusion Criteria
* Current treatment with PCSK9 monoclonal antibody therapy
* Current or past treatment with inclisiran
* Clinically significant or abnormal laboratory values as defined by the protocol
18 Years
75 Years
ALL
No
Sponsors
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Verve Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Study Center
Auckland, , New Zealand
Clinical Study Center
Christchurch, , New Zealand
Clinical Study Center
London, , United Kingdom
Countries
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Other Identifiers
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VT-1001
Identifier Type: -
Identifier Source: org_study_id
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