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VERVE-101

Phase 1

Heterozygous Familial Hypercholesterolemia | Small molecule | Cardiovascular |Verve Therapeutics, Inc.|Last Updated: May 8, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

VERVE-101 · 1 trial · 3 indications

Phase 1 1
NCT05398029A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular DiseaseHeterozygous Familial Hypercholesterolemia
COMPLETED13 Analytics
PHASE1COMPLETED
A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease
Heterozygous Familial HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).
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/Adaptive DesignEXPERIMENTALParticipants will receive a single dose of VERVE-101 in multiple dose-escalation cohorts.
Part B: Single Dose ExpansionEXPERIMENTALParticipants will receive a single dose of VERVE-101 selected based on the doses studied in Part A.

Interventions

NameTypeDescription
VERVE-101DRUGIntravenous (IV) infusion.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Male and/or female participants 18 up to 75 years at time of signing of informed consent * Female participants not of child-bearing potential * Diagnosis of HeFH * Established ASCVD Exclusion Criteria: * Active or history of chronic liver disease * Current treatment with PCS...

Countries:New ZealandUnited Kingdom
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Frequently asked questions about VERVE-101

What is VERVE-101 used for?

VERVE-101 is an investigational small molecule being developed for the treatment of heterozygous familial hypercholesterolemia, a genetic condition causing high cholesterol. It is also being studied in patients with atherosclerotic cardiovascular disease and hypercholesterolemia. The drug is currently in clinical development and has not been approved by regulatory authorities.

What does VERVE-101 target?

VERVE-101 is a small molecule designed to treat heterozygous familial hypercholesterolemia by targeting the underlying genetic cause of the condition. As a small molecule, it works at the molecular level to address the elevated cholesterol levels associated with this disorder. The specific molecular target has not been disclosed in available information.

Who makes VERVE-101?

VERVE-101 is being developed by Verve Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VERV. The company is focused on developing therapies for cardiovascular diseases, and VERVE-101 is one of its lead investigational candidates currently in clinical trials.

What phase is VERVE-101 in?

VERVE-101 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing to evaluate its safety and efficacy in patients with familial hypercholesterolemia.

What clinical trials is VERVE-101 in?

VERVE-101 has been studied in one clinical trial with the identifier NCT05398029. This Phase 1 study, titled 'A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease,' enrolled 13 participants in New Zealand and the United Kingdom. The trial has been completed and included patients aged 18 years and older.

Is VERVE-101 the same as any other drug?

VERVE-101 is the primary name for this investigational drug developed by Verve Therapeutics. No alternative names have been reported for this compound in available information. It is a distinct small molecule being studied for the treatment of heterozygous familial hypercholesterolemia and related cardiovascular conditions.