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VERVE-102

Phase 1

Heterozygous Familial Hypercholesterolemia | Small molecule | Cardiovascular |Verve Therapeutics, Inc.|Last Updated: Aug 3, 2026

Target and mechanism

Molecular targetPCSK9
Target classGene
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

VERVE-102 · 1 trial · 2 indications

Phase 1 1
NCT06164730A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery DiseaseHeterozygous Familial Hypercholesterolemia
RECRUITING85 Analytics
PHASE1RECRUITING
A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease
Heterozygous Familial 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-102.
Cohort 2: Single Ascending Dose EscalationEXPERIMENTALParticipants will receive a single dose of VERVE-102.
Cohort 3: Single Ascending Dose EscalationEXPERIMENTALParticipants will receive a single dose of VERVE-102.
Cohort 4: Single Ascending Dose EscalationEXPERIMENTALParticipants will receive a single dose of VERVE-102.
Cohort 5: Single Ascending Dose EscalationEXPERIMENTALParticipants will receive a single dose of VERVE-102.
Cohort 6: Single Ascending Dose EscalationEXPERIMENTALParticipants will receive a single dose of VERVE-102.
Cohort 7: Single Ascending Dose EscalationEXPERIMENTALParticipants will receive a single dose of VERVE-102.
Cohort 8: Single Ascending Dose EscalationEXPERIMENTALParticipants will receive a single dose of VERVE-102.
Cohort 9: Single Fixed DoseEXPERIMENTALParticipants will receive a single dose of VERVE-102.
Cohort 10: Single Fixed DoseEXPERIMENTALParticipants will receive a single dose of VERVE-102.

Interventions

NameTypeDescription
VERVE-102DRUGIntravenous (IV) infusion
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Diagnosis of HeFH or premature CAD Exclusion Criteria: * Homozygous familial hypercholesterolemia * Active or history of chronic liver disease * Current treatment with PCSK9 inhibitor or prior treatment within specified timeframe * Clinically significant or abnormal laborato...

Countries:United StatesAustraliaCanadaIsraelNew ZealandUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 3, 2026NCT06164730lastUpdatePostDate: changed
LOWJul 13, 2026NCT06164730lastUpdatePostDate: changed
LOWJul 13, 2026NCT06164730lastUpdatePostDate: changed
LOWJun 29, 2026NCT06164730lastUpdatePostDate: changed
LOWJun 29, 2026NCT06164730lastUpdatePostDate: changed
LOWJun 2, 2026NCT06164730lastUpdatePostDate: changed
LOWJun 2, 2026NCT06164730lastUpdatePostDate: changed
LOWJun 2, 2026NCT06164730lastUpdatePostDate: changed
LOWMay 26, 2026NCT06164730primaryCompletionDate: changed
LOWMay 24, 2026NCT06164730studyFirstPostDate: changed

Frequently asked questions about VERVE-102

What is VERVE-102 used for?

VERVE-102 is an investigational small molecule being developed for the treatment of heterozygous familial hypercholesterolemia, a genetic condition that causes high cholesterol. It is also being studied in patients with premature coronary artery disease. The drug is currently in Phase 1 clinical development.

What does VERVE-102 target?

VERVE-102 targets the PCSK9 gene. By targeting this gene, the drug is designed to address the underlying genetic cause of elevated cholesterol levels in patients with heterozygous familial hypercholesterolemia. The drug is a small molecule that acts on this gene target.

Who is developing VERVE-102?

VERVE-102 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-102 in patients with familial hypercholesterolemia.

What phase is VERVE-102 in?

VERVE-102 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The Phase 1 trial is currently recruiting participants to evaluate the drug's safety, tolerability, and effects in patients with heterozygous familial hypercholesterolemia or premature coronary artery disease.

What clinical trials is VERVE-102 in?

VERVE-102 is being studied in a Phase 1 clinical trial registered as NCT06164730. This trial is titled 'A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease' and is currently recruiting. The study is enrolling approximately 85 participants across multiple countries, including the United States, Australia, Canada, Israel, New Zealand, and the United Kingdom.

Is VERVE-102 the same as other PCSK9 inhibitors?

VERVE-102 is a distinct investigational drug that targets the PCSK9 gene. It is a small molecule designed to act on this gene, which differentiates it from other PCSK9-targeting therapies. The drug is being developed specifically for heterozygous familial hypercholesterolemia and is currently in Phase 1 clinical trials.