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NCT Number: NCT06164730

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

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.

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Key information

Conditions

Heterozygous Familial Hypercholesterolemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary Artery Disease Coronary Disease Dyslipidemias Genetic Diseases, Inborn Heart Diseases Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Myocardial Ischemia Nutritional and Metabolic Diseases Premature Coronary Heart Disease Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Study Center, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

VERVE-102

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 plasma PCSK9 concentration

    Time frame: up to Day 365

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

    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

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 11, 2023
Registry last updated
Jul 13, 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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