NCT06164730|RecruitingPhase 1DMCFDA Drug

A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease

Open-label, Phase 1b, Single Ascending Dose Study to Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia or Premature Coronary Artery Disease Who Require Additional Lowering of Low-density Lipoprotein Cholesterol

Verve Therapeutics, Inc.ClinicalTrials.gov

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1 other identifier

VT-10201

Study Type

interventional

Target

Locations

6 countries

Sites

Timeline

RegisteredDec 2023

StartedApr 2024

CompletionAug 2027

Brief Summary

VT-10201 is an Open-label, Phase 1b, Single-ascending Dose Study That Will Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia (HeFH) or Premature Coronary Artery Disease (CAD) Who Require Additional Lowering of LDL-C. VERVE-102 Uses Base-editing Technology Designed to Disrupt the Expression of the PCSK9 Gene in the Liver and Lower Circulating PCSK9 and LDL-C. This Study is Designed to Determine the Safety and Pharmacodynamic Profile of VERVE-102 in This Patient Population.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

15mo left

Started Apr 2024

Typical duration for phase_1

Geographic Reach

6 countries

22 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

Study Progress62%

Apr 2024Aug 2027

First Submitted

Initial submission to the registry

December 1, 2023

Completed

10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed

5 months until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

December 1, 2023

Last Update Submit

March 31, 2026

Conditions

Heterozygous Familial Hypercholesterolemia Premature Coronary Heart Disease

Keywords

VERVE-102Familial HypercholesterolemiaCoronary Artery DiseaseDose EscalationGene EditingBase Editingheart-2

Outcome Measures

Primary Outcomes (1)

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
up to Day 365

Secondary Outcomes (5)

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
Percent and absolute change from baseline in plasma PCSK9 concentration
up to Day 365
Percent and absolute change from baseline in LDL-C
up to Day 365