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NCT Number: NCT06451770

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

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.

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Key information

Conditions

Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Hypertriglyceridemia Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Refractory Hyperlipidemia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Study Center, Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VERVE-201

Drug

Intravenous (IV) infusion

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: Up to Day 365

Secondary outcomes

  1. Evaluation of maximum observed concentration (Cmax)

    Time frame: Up to Day 365

  2. Evaluation of time to maximum observed concentration (tmax)

    Time frame: Up to Day 365

  3. Evaluation of terminal elimination half-life (t1/2)

    Time frame: Up to Day 365

  4. Percent and absolute change from baseline in serum ANGPTL3 concentration

    Time frame: Up to Day 365

  5. Percent and absolute change from baseline in serum LDL-C

    Time frame: Up to Day 365

  6. Percent and absolute change from baseline in serum triglycerides

    Time frame: Up to Day 365

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

317-615-4559

Sponsors and collaborators

Lead sponsor

Verve Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1b Single Ascending Dose Study to Evaluate the Safety of VERVE-201 in Patients With Refractory Hyperlipidemia

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2024
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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