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Base-editing Technology
VERVE-102 for High Cholesterol
Phase 1
Recruiting
Research Sponsored by Verve Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of HeFH or premature CAD
Females of non-childbearing potential or males
Must not have
Homozygous familial hypercholesterolemia
Active or history of chronic liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing a new medication called VERVE-102 on patients with high cholesterol or heart disease. The medication uses a technology that targets a specific gene in the liver to lower cholesterol levels. The
Who is the study for?
This trial is for patients with familial hypercholesterolemia or premature coronary artery disease who need extra help lowering their LDL cholesterol. It's open to men and women who can't have children.
What is being tested?
VERVE-102, a new treatment using base-editing technology, is being tested. It aims to disrupt the PCSK9 gene in the liver, which should lower bad cholesterol levels. This early-phase study will check its safety and how it affects patients.
What are the potential side effects?
Since this is an early-stage trial for VERVE-102, specific side effects are not listed but may include reactions related to gene editing such as immune responses or off-target genetic effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with familial hypercholesterolemia or early-onset coronary artery disease.
Select...
I am either a male or a female who cannot become pregnant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a genetic condition that causes very high cholesterol.
Select...
I have or had liver disease.
Select...
I am currently taking or have recently taken a PCSK9 inhibitor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4: Single Ascending Dose EscalationExperimental Treatment1 Intervention
Participants will receive a single dose of VERVE-102.
Group II: Cohort 3: Single Ascending Dose EscalationExperimental Treatment1 Intervention
Participants will receive a single dose of VERVE-102.
Group III: Cohort 2: Single Ascending Dose EscalationExperimental Treatment1 Intervention
Participants will receive a single dose of VERVE-102.
Group IV: Cohort 1: Single Ascending Dose EscalationExperimental Treatment1 Intervention
Participants will receive a single dose of VERVE-102.
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Who is running the clinical trial?
Verve Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
160 Total Patients Enrolled
3 Trials studying Hypercholesterolemia
160 Patients Enrolled for Hypercholesterolemia
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