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A Phase 1b Single Ascending Dose Study to Evaluate the Safety of VERVE-201 in Patients With Refractory Hyperlipidemia
Led by Verve Therapeutics, Inc. · Updated on 2026-04-28
36
Participants Needed
10
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating VERVE-201, a drug using base-editing technology to turn off the ANGPTL3 gene in the liver, in patients with refractory hyperlipidemia. This Phase 1b open-label study aims to assess the safety and how the drug affects cholesterol and triglyceride levels in this group. Participants will receive a single intravenous dose of VERVE-201 in one of six ascending dose groups. The study is designed as a non-randomized, open-label trial where each participant receives the investigational treatment only. During the study, researchers will monitor participants for up to one year to observe any treatment-related side effects and measure changes in LDL cholesterol, triglycerides, and ANGPTL3 levels. Safety assessments and blood tests will be done regularly to track the drug's effects over time.
CONDITIONS
Brief Title
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Refractory hypercholesterolemia
- Refractory hypertriglyceridemia
- Age between 18 and 70 years
You will not qualify if you...
- Active or history of chronic liver disease
- Current treatment with monoclonal antibody targeting ANGPTL3 or prior treatment within specified timeframe
- Clinically significant or abnormal laboratory values as defined by the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 day
Participants receive a single intravenous dose of VERVE-201 to evaluate safety and pharmacokinetics.
1 visit (in-person)
Duration - Up to 365 days
Participants are monitored for safety and study outcomes including adverse events and changes in lipid levels.
Regular visits for up to 1 year
Trial Site Locations
Total: 10 locations
1
Clinical Study Center
Adelaide, Australia
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2
Clinical Study Center
Melbourne, Australia
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3
Clinical Study Center
Chicoutimi, Canada
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4
Clinical Study Center
Montreal, Canada
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5
Clinical Study Center
Toronto, Canada
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6
Clinical Study Center
Cape Town, South Africa
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7
Clinical Study Center
Johannesburg, South Africa
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8
Clinical Study Center
Liverpool, United Kingdom
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9
Clinical Study Center
London, United Kingdom
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10
Clinical Study Center
Manchester, United Kingdom
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Research Team
C
Clinical Development
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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