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Base-editing Technology

VERVE-201 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
Refractory hypercholesterolemia
Females of non-childbearing potential or males
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the safety of a new drug, VERVE-201, in patients with high cholesterol that has not responded to other treatments. The drug works by targeting a specific gene in the

Who is the study for?
This trial is for men and women who cannot bear children and have refractory hypercholesterolemia, which means their high cholesterol levels remain high despite treatment. Participants should not be able to get pregnant because the effects of VERVE-201 on childbearing are unknown.
What is being tested?
VERVE-201, a new therapy using base-editing technology, is being tested in this Phase 1b study. It aims to turn off a gene in the liver responsible for high LDL-C (bad cholesterol) levels. The goal is to see if it's safe and how it affects patients' cholesterol.
What are the potential side effects?
Since this is an early-phase trial focusing on safety, specific side effects of VERVE-201 are not yet fully known but may include potential liver issues due to gene editing or immune reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My high cholesterol does not improve with treatment.
Select...
I am either not able to become pregnant or I am a male.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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-201.
Group II: Cohort 3: Single Ascending Dose EscalationExperimental Treatment1 Intervention
Participants will receive a single dose of VERVE-201.
Group III: Cohort 2: Single Ascending Dose EscalationExperimental Treatment1 Intervention
Participants will receive a single dose of VERVE-201.
Group IV: Cohort 1: Single Ascending Dose EscalationExperimental Treatment1 Intervention
Participants will receive a single dose of VERVE-201.

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Who is running the clinical trial?

Verve Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
160 Total Patients Enrolled
~24 spots leftby Mar 2027
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