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Open-label, Phase 1b Single Ascending Dose Study to Evaluate Safety of VERVE-102 in Patients With Heterozygous Familial Hypercholesterolemia or Premature Coronary Artery Disease Needing More LDL Cholesterol Lowering
Led by Verve Therapeutics, Inc. · Updated on 2026-06-02
85
Participants Needed
23
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying VERVE-102, a drug designed to lower LDL cholesterol by targeting the PCSK9 gene in the liver, in adults with heterozygous familial hypercholesterolemia (HeFH) or premature coronary artery disease (CAD) who need additional LDL-C reduction. This open-label, Phase 1b study aims to evaluate the safety and pharmacodynamics of VERVE-102 in this patient group. Participants will receive a single intravenous infusion dose of VERVE-102 as part of a single ascending dose study. The study includes up to ten cohorts, each receiving different doses to assess safety and response. The treatment period focuses on the effects of one dose, with monitoring continuing for up to one year. During the study, participants will be monitored for treatment-emergent and serious adverse events up to 365 days. Researchers will measure drug concentration levels, timing of peak concentration, elimination half-life, and changes in plasma PCSK9 and LDL cholesterol levels. These evaluations will help determine the drug's safety and its impact on cholesterol over a full year of follow-up.
CONDITIONS
Brief Title
A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of heterozygous familial hypercholesterolemia (HeFH) or premature coronary artery disease (CAD)
- Age between 18 and 70 years
- Both males and females eligible
You will not qualify if you...
- Diagnosis of homozygous familial hypercholesterolemia
- Current or history of chronic liver disease
- Current treatment with PCSK9 inhibitors 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-102.
1 dosing visit (in-person) and follow-up assessments
Duration - Up to 365 days
Participants are monitored for safety and changes in cholesterol levels for up to 365 days after dosing.
Regular follow-up visits during the 1-year monitoring period
Trial Site Locations
Total: 23 locations
1
Clinical Study Center
Dothan, Alabama, United States, 36305
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2
Clinical Study Center
Pomona, California, United States, 91768
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3
Clinical Study Center
Boca Raton, Florida, United States, 33434
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4
Clinical Study Center
Jacksonville, Florida, United States, 32216
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5
Clinical Study Center
Winter Park, Florida, United States, 32789
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6
Clinical Study Center
High Point, North Carolina, United States, 27260
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7
Clinical Study Center
DeSoto, Texas, United States, 75115
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8
Clinical Study Center
Renton, Washington, United States, 98057
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9
Clinical Study Center
Adelaide, Australia
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10
Clinical Study Center
Melbourne, Australia
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11
Clinical Study Center
Sydney, Australia
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12
Clinical Study Center
Chicoutimi, Canada
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13
Clinical Study Center
Montreal, Canada
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14
Clinical Study Center
Québec, Canada
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15
Clinical Study Center
Toronto, Canada
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16
Clinical Study Center
Vancouver, Canada
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17
Clinical Study Center
Rehovot, Israel
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18
Clinical Study Center
Christchurch, New Zealand
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19
Clinical Study Center
Birmingham, United Kingdom
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20
Clinical Study Center
Edinburgh, United Kingdom
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21
Clinical Study Center
London, United Kingdom
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22
Clinical Study Center
Manchester, United Kingdom
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23
Clinical Study Center
Nottingham, 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
10
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