Recruiting
Phase 1

VERVE-102

Sponsor:

Verve Therapeutics, Inc.

Code:

NCT06164730

Conditions

Heterozygous Familial Hypercholesterolemia

Premature Coronary Heart Disease

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

VERVE-102

Study Details

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.

Conditions

Heterozygous Familial Hypercholesterolemia

Premature Coronary Heart Disease

Study ID

NCT06164730

Start date

Apr 30, 2024

Status verified date

Aug, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 laboratory values as defined by the protocol

Study Design

Enrollment

85 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-102.

experimental: Cohort 2: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-102.

experimental: Cohort 3: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-102.

experimental: Cohort 4: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-102.

experimental: Cohort 5: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-102.

experimental: Cohort 6: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-102.

experimental: Cohort 7: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-102.

experimental: Cohort 8: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-102.

experimental: Cohort 9: Single Fixed Dose

Participants will receive a single dose of VERVE-102.

experimental: Cohort 10: Single Fixed Dose

Participants will receive a single dose of VERVE-102.

Interventions

VERVE-102

Intravenous (IV) infusion

Primary outcome measure

  • Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: up to Day 365 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Clinical Study Center

Recruiting

Dothan, Alabama, United States, 36305

Clinical Study Center

Recruiting

Pomona, California, United States, 91768

Clinical Study Center

Recruiting

Boca Raton, Florida, United States, 33434

Clinical Study Center

Recruiting

Jacksonville, Florida, United States, 32216

Clinical Study Center

Recruiting

Winter Park, Florida, United States, 32789

Clinical Study Center

Recruiting

Indianapolis, Indiana, United States, 46237

Clinical Study Center

Recruiting

High Point, North Carolina, United States, 27260

Clinical Study Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Clinical Study Center

Recruiting

DeSoto, Texas, United States, 75115

Clinical Study Center

Recruiting

Renton, Washington, United States, 98057

Clinical Study Center

Recruiting

Chicoutimi, Canada

Clinical Study Center

Recruiting

Hamilton, Canada

Clinical Study Center

Recruiting

Montreal, Canada

Clinical Study Center

Recruiting

Québec, Canada

Clinical Study Center

Recruiting

Toronto, Canada

Clinical Study Center

Recruiting

Vancouver, Canada

More Information

Sponsor

Verve Therapeutics, Inc.

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • VERVE-102
  • Familial Hypercholesterolemia
  • Coronary Artery Disease
  • Dose Escalation
  • Gene Editing
  • Base Editing
  • heart-2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Verve Therapeutics, Inc. on 2026-09-02.