Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Single ascending dose escalation/adaptive design
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: Single Ascending Dose Escalation 		Participants will receive a single dose of VERVE-201.
  • Drug: VERVE-201
    Intravenous (IV) infusion
Experimental
Cohort 2: Single Ascending Dose Escalation 		Participants will receive a single dose of VERVE-201.
  • Drug: VERVE-201
    Intravenous (IV) infusion
Experimental
Cohort 3: Single Ascending Dose Escalation 		Participants will receive a single dose of VERVE-201.
  • Drug: VERVE-201
    Intravenous (IV) infusion
Experimental
Cohort 4: Single Ascending Dose Escalation 		Participants will receive a single dose of VERVE-201.
  • Drug: VERVE-201
    Intravenous (IV) infusion
Experimental
Cohort 5: Single Ascending Dose Escalation 		Participants will receive a single dose of VERVE-201.
  • Drug: VERVE-201
    Intravenous (IV) infusion
Experimental
Cohort 6: Single Ascending Dose Escalation 		Participants will receive a single dose of VERVE-201.
  • Drug: VERVE-201
    Intravenous (IV) infusion

Recruiting Locations

Clinical Study Center
Clearwater, Florida 33756

Clinical Study Center
Miami Lakes, Florida 33016

Clinical Study Center
Port Orange, Florida 32127

Clinical Study Center
New York, New York 10029

More Details

Status
Recruiting
Sponsor
Verve Therapeutics, Inc.

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
317-615-4559
LillyTrials@Lilly.com