Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
For Condition: HypercholesterolemiaFor Condition: HypertriglyceridemiaFor Condition: Refractory Hyperlipidemia
ID: NCT06451770
Horizon Patient Guidance Summary
Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:
How it’s taken
Injections / IV Shots
Expected Availability Horizon
Long-term Hope (5+ yrs away)
StageEarly Clinical Stage: Focuses strictly on testing basic safety, toxicity, and dosage in a small group (10–50 people). Represents early-stage scientific hope.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial
VT-20101 is an Open-label, Phase 1b, Single-ascending dose study that will evaluate the safety of VERVE-201 administered to patients with Refractory Hyperlipidemia.
VERVE-201 uses base-editing technology designed to inactivate the expression of the ANGPTL3 gene in the liver and lower circulating low-density lipoprotein cholesterol (LDL-C) and triglycerides. This study is designed to determine the safety and pharmacodynamic profile of VERVE-201 in this patient population.
Study Timeline & Quick Facts
Trial Status
Open — Looking for Participants
Total Target Enrollment
36 patients (Estimated)
Study Start Date
2024-10-30
Est. Primary Completion
2027-12
Tested Drugs & Treatment Groups
DRUGVERVE-201
Intravenous (IV) infusion
Treatment Arms Description
EXPERIMENTALCohort 1: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-201.
EXPERIMENTALCohort 2: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-201.
EXPERIMENTALCohort 3: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-201.
EXPERIMENTALCohort 4: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-201.
EXPERIMENTALCohort 5: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-201.
EXPERIMENTALCohort 6: Single Ascending Dose Escalation
Participants will receive a single dose of VERVE-201.
Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
Between 18 Years and 70 Years
Full Criteria Checklist
Who Can Join
Refractory hypercholesterolemia
Refractory hypertriglyceridemia
Who Cannot Join
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
What is this Study Measuring?
Primary Outcome Measures
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) — Time Frame: Up to Day 365
View Secondary Outcome Measures (6)
Evaluation of maximum observed concentration (Cmax) — Time Frame: Up to Day 365
Evaluation of time to maximum observed concentration (tmax) — Time Frame: Up to Day 365
Evaluation of terminal elimination half-life (t1/2) — Time Frame: Up to Day 365
Percent and absolute change from baseline in serum ANGPTL3 concentration — Time Frame: Up to Day 365
Percent and absolute change from baseline in serum LDL-C — Time Frame: Up to Day 365
Percent and absolute change from baseline in serum triglycerides — Time Frame: Up to Day 365
Where to Participate
This trial is recruiting at 16 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 16 Facilities & Contact Sites
Clinical Study Center
Clearwater, Florida, United States
Status: Open
Clinical Study Center
Miami Lakes, Florida, United States
Status: Open
Clinical Study Center
Port Orange, Florida, United States
Status: Open
Clinical Study Center
New York, New York, United States
Status: Open
Clinical Study Center
Adelaide, Australia
Status: Open
Clinical Study Center
Melbourne, Australia
Status: Open
Clinical Study Center
Chicoutimi, Canada
Status: Open
Clinical Study Center
Montreal, Canada
Status: Open
Clinical Study Center
Toronto, Canada
Status: Open
Clinical Study Center
Amsterdam, Netherlands
Status: Open
Clinical Study Center
Cape Town, South Africa
Status: Open
Clinical Study Center
Johannesburg, South Africa
Status: Open
Clinical Study Center
Liverpool, United Kingdom
Status: Open
Clinical Study Center
London, United Kingdom
Status: Open
Clinical Study Center 2
Manchester, United Kingdom
Status: Open
Clinical Study Center
Manchester, United Kingdom
Status: Open
Trial Design & Scientific Setup
Allocation
non_randomized
Intervention Model
sequential
Primary Purpose
treatment
Masking
none
Sponsoring Teams & Contacts
Lead Sponsoring Institution
Verve Therapeutics, Inc.
Primary Research Contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Want to apply or inquire about joining this study? Fill out this simple questionnaire, and our assistant will instantly generate a professional email draft you can copy and send to the central contact coordinator listed above!
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Subject: Inquiry about clinical trial enrollment: NCT06451770 - Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Dear Study Coordinator / Research Team,
I hope this message finds you well.
My name is [Your Name], and I am writing to express my strong interest in participating in the clinical trial titled "Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia" (NCT ID: NCT06451770).
I am [Age] years old and have been diagnosed with Hypercholesterolemia. I have reviewed the eligibility criteria for this study on Med Code Info and believe I may be a suitable candidate.
Could you please let me know if this study is actively enrolling patients at any site near my location, and what the next steps are to undergo screening?
Thank you for your time and research efforts.
Warm regards,
[Your Name]
View Official Medical/Scientific Title
A Phase 1b Single Ascending Dose Study to Evaluate the Safety of VERVE-201 in Patients With Refractory Hyperlipidemia
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Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia — NCT06451770 | Med-Code