Recruiting
Phase 1

VERVE-201

Sponsor:

Verve Therapeutics, Inc.

Code:

NCT06451770

Conditions

Hypercholesterolemia

Hypertriglyceridemia

Refractory Hyperlipidemia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

VERVE-201

Study Details

Brief summary:

VT-20101 is an Open-label, Phase 1b, Single-ascending dose study that will evaluate the safety of VERVE-201 administered to patients with Refractory Hyperlipidemia.

VERVE-201 uses base-editing technology designed to inactivate the expression of the ANGPTL3 gene in the liver and lower circulating low-density lipoprotein cholesterol (LDL-C) and triglycerides. This study is designed to determine the safety and pharmacodynamic profile of VERVE-201 in this patient population.

Conditions

Hypercholesterolemia

Hypertriglyceridemia

Refractory Hyperlipidemia

Study ID

NCT06451770

Start date

Oct 30, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 abnormal laboratory values as defined by the protocol

Study Design

Enrollment

36 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-201.

experimental: Cohort 2: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-201.

experimental: Cohort 3: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-201.

experimental: Cohort 4: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-201.

experimental: Cohort 5: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-201.

experimental: Cohort 6: Single Ascending Dose Escalation

Participants will receive a single dose of VERVE-201.

Interventions

VERVE-201

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

Clearwater, Florida, United States, 33756

Clinical Study Center

Recruiting

Miami Lakes, Florida, United States, 33016

Clinical Study Center

Recruiting

Port Orange, Florida, United States, 32127

Clinical Study Center

Recruiting

New York, New York, United States, 10029

Clinical Study Center

Recruiting

Chicoutimi, Canada

Clinical Study Center

Recruiting

Montreal, Canada

Clinical Study Center

Recruiting

Toronto, Canada

More Information

Sponsor

Verve Therapeutics, Inc.

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • VERVE-201
  • Gene Editing
  • Base Editing
  • Refractory Hypercholesterolemia
  • ANGPTL3
  • ASCVD
  • Refractory Hypertriglyceridemia
  • Refractory Hyperlipidemia
  • Familial Hypercholesterolemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Verve Therapeutics, Inc. on 2026-07-17.