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VERVE-201

Phase 1

Hypercholesterolemia | Small molecule | Metabolic |Verve Therapeutics, Inc.|Trials Updated: Oct 23, 2026

VERVE-201 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2024

VERVE-201 target and mechanism

Molecular targetANGPTL3
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment132

FDA Designations

No designations recorded

VERVE-201 clinical trials

VERVE-201 · 1 trial · 3 indications

Phase 1 1
NCT06451770Phase 1b Study of VERVE-201 in Patients With Refractory HyperlipidemiaHypercholesterolemia
RECRUITING132 Analytics
PHASE1RECRUITING
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Up to Day 365

Secondary Endpoints

Evaluation of maximum observed concentration (Cmax)
Up to Day 365
Evaluation of time to maximum observed concentration (tmax)
Up to Day 365
Evaluation of terminal elimination half-life (t1/2)
Up to Day 365
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Single Ascending Dose Escalation for Participants with Refractory HypercholesterolemiaEXPERIMENTALParticipants assigned to a dose-escalation cohort will receive a single dose of VERVE-201.
Part B: Re-Dosing for Part A ParticipantsEXPERIMENTALParticipants from Part A assigned to the re-dosing cohort will receive a second dose of VERVE-201.
Part C: Single Ascending Dose Escalation for Participants with sHTGEXPERIMENTALParticipants assigned to a dose-expansion cohort will receive a single dose of VERVE-201.

Interventions

NameTypeDescription
VERVE-201DRUGIntravenous (IV) infusion
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Refractory hypercholesterolemia * Refractory hypertriglyceridemia Exclusion Criteria: * Active or history of chronic liver disease * Current treatment with monoclonal antibody targeting ANGPTL3 or prior treatment within specified timeframe * Clinically significant or abnorma...

Countries:United StatesAustraliaCanadaNetherlandsSouth AfricaUnited Kingdom
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Recent Changes (Last 90 Days)

LOWOct 24, 2026NCT06451770Enrollment: 36 → 132
LOWOct 24, 2026NCT06451770Enrollment: 36 → 132
LOWOct 24, 2026NCT06451770Enrollment: 36 → 132
LOWOct 24, 2026NCT06451770Enrollment: 36 → 132

Frequently asked questions about VERVE-201

What is VERVE-201?

VERVE-201 is an investigational small molecule developed by Verve Therapeutics for hypercholesterolemia. It is designed to act on ANGPTL3 and is being studied in a Phase 1b trial in patients with refractory hyperlipidemia, a condition in which cholesterol and triglyceride levels remain elevated despite treatment.

What does VERVE-201 target?

VERVE-201 targets ANGPTL3, also known as angiopoietin-like protein 3. ANGPTL3 is a molecular target relevant to lipid metabolism, and VERVE-201 is a small molecule designed to act on it. The compound is being developed for hypercholesterolemia and related lipid disorders.

Who is developing VERVE-201?

VERVE-201 is being developed by Verve Therapeutics, Inc., which trades under the ticker VERV. The company is running the Phase 1b program for the drug in patients with refractory hyperlipidemia across sites in the United States, Australia, Canada, the Netherlands, South Africa, and the United Kingdom.

What phase is VERVE-201 in?

VERVE-201 is in Phase 1 development. It is investigational and is being evaluated in a Phase 1b study in patients with refractory hyperlipidemia. No Phase 2 or later-stage trial of VERVE-201 is listed, and the program remains in clinical development.

What clinical trials is VERVE-201 in?

VERVE-201 is being studied in the Phase 1b trial NCT06451770, titled a Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia. The trial is recruiting and plans to enroll 132 participants aged 18 years and older, with conditions including hypercholesterolemia, hypertriglyceridemia, and refractory hyperlipidemia.

What is VERVE-201 used for in hypercholesterolemia?

VERVE-201 is being developed for hypercholesterolemia, specifically for patients with refractory hyperlipidemia whose lipid levels remain elevated. The Phase 1b trial NCT06451770 also enrolls patients with hypertriglyceridemia. VERVE-201 is investigational and has not been established as a treatment outside clinical research.