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VERVE-201

Phase 1

Hypercholesterolemia | Small molecule | Metabolic |Verve Therapeutics, Inc.|Last Updated: Jul 17, 2026

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 Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

VERVE-201 · 1 trial · 3 indications

Phase 1 1
NCT06451770Phase 1b Study of VERVE-201 in Patients With Refractory HyperlipidemiaHypercholesterolemia
RECRUITING36 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
Cohort 1: Single Ascending Dose EscalationEXPERIMENTALParticipants will receive a single dose of VERVE-201.
Cohort 2: Single Ascending Dose EscalationEXPERIMENTALParticipants will receive a single dose of VERVE-201.
Cohort 3: Single Ascending Dose EscalationEXPERIMENTALParticipants will receive a single dose of VERVE-201.
Cohort 4: Single Ascending Dose EscalationEXPERIMENTALParticipants will receive a single dose of VERVE-201.
Cohort 5: Single Ascending Dose EscalationEXPERIMENTALParticipants will receive a single dose of VERVE-201.
Cohort 6: Single Ascending Dose EscalationEXPERIMENTALParticipants 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 Sites16

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)

LOWJul 17, 2026NCT06451770lastUpdatePostDate: changed
LOWJul 17, 2026NCT06451770lastUpdatePostDate: changed
LOWMay 26, 2026NCT06451770primaryCompletionDate: changed
LOWMay 24, 2026NCT06451770studyFirstPostDate: changed

Frequently asked questions about VERVE-201

What is VERVE-201 used for?

VERVE-201 is an investigational small molecule being developed for hypercholesterolemia, a condition of high cholesterol. It is also being studied in patients with refractory hyperlipidemia, which includes hypercholesterolemia and hypertriglyceridemia. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does VERVE-201 target?

VERVE-201 targets ANGPTL3, a protein involved in lipid metabolism. By targeting ANGPTL3, the drug aims to address hypercholesterolemia and related lipid disorders. The drug is a small molecule, and its mechanism of action is centered on this molecular target.

Who makes VERVE-201?

VERVE-201 is being developed by Verve Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol VERV. Verve Therapeutics is conducting clinical trials to evaluate the safety and efficacy of VERVE-201 in patients with hyperlipidemia.

What phase is VERVE-201 in?

VERVE-201 is in Phase 1 clinical development. It is currently being studied in a Phase 1b trial for patients with refractory hyperlipidemia. The drug is investigational and has not been approved by the FDA or other regulatory agencies. The trial is actively recruiting participants.

What clinical trials is VERVE-201 in?

VERVE-201 is being evaluated in a Phase 1b clinical trial with the identifier NCT06451770. This study is recruiting patients with refractory hyperlipidemia, including hypercholesterolemia and hypertriglyceridemia. The trial is enrolling 36 participants across multiple countries, including the United States, Australia, Canada, Netherlands, South Africa, and the United Kingdom.

Is VERVE-201 the same as any other drug?

VERVE-201 is the sole name provided for this investigational drug. No alternative names have been mentioned in the available information. It is a distinct small molecule being developed by Verve Therapeutics for the treatment of hypercholesterolemia and related lipid disorders.