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VERVE-201

Phase 1

Hypercholesterolemia | Small molecule | Metabolic |Verve Therapeutics, Inc.|Last Updated: Apr 28, 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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06451770Phase 1b Study of VERVE-201 in Patients With Refractory HyperlipidemiaPHASE1 RECRUITING 36Oct 30, 2024Dec 1, 2027Apr 28, 202610 Australia, Canada +2
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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-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 — 70 Years
SexALL
Healthy VolunteersNo
Study Sites10

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:AustraliaCanadaSouth AfricaUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06451770primaryCompletionDate: changed
LOWMay 24, 2026NCT06451770studyFirstPostDate: changed