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VERVE-102

Phase 1

Heterozygous Familial Hypercholesterolemia | Small molecule | Cardiovascular |Verve Therapeutics, Inc.|Last Updated: Jun 2, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMC
Total Trials1
Total Enrollment85
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06164730A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery DiseasePHASE1 RECRUITING 85 — — Apr 30, 2024Aug 1, 2027Jun 2, 202623 United States, Australia +4
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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 — 70 Years
SexALL
Healthy VolunteersNo
Study Sites23

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)
LOWJun 2, 2026NCT06164730lastUpdatePostDate: changed
LOWJun 2, 2026NCT06164730lastUpdatePostDate: changed
LOWJun 2, 2026NCT06164730lastUpdatePostDate: changed
LOWMay 26, 2026NCT06164730primaryCompletionDate: changed
LOWMay 24, 2026NCT06164730studyFirstPostDate: changed