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NCT Number: NCT07839936

A Study of VERVE-102 (LY4636581) in Adults With or at High Risk for Cardiovascular Disease

The purpose of this study is to measure the change in bad cholesterol (LDL-C) with VERVE-102 compared to placebo in adults who have plaque buildup in their arteries or are at high risk of developing it.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Disease Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Artery Disease Coronary Disease Dyslipidemias Heart Diseases Hypercholesterolemia Hyperlipidemias Infarction Ischemia Lipid Metabolism Disorders Metabolic Diseases Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Epic Medical Research

DeSoto, Texas, 75115, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Established atherosclerotic cardiovascular disease (ASCVD) and/or at a high risk of ASCVD

Exclusion criteria

  • History of confirmed or suspected homozygous familial hypercholesterolemia (HoFH)
  • Chronic liver disease
  • Current treatment with PCSK9 inhibitor or prior treatment within specified timeframe

Treatment and study plan

VERVE-102

Drug

Administered IV

Other names: LY4636581

Placebo

Drug

Administered IV

Primary outcomes

  1. Percent Change from Baseline in LDL-C

    Time frame: Baseline, Day 90

Secondary outcomes

  1. Percent Change from Baseline in LDL-C

    Time frame: Baseline to End of Study (up to Day 365)

  2. Percent Change from Baseline in Circulating Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)

    Time frame: Baseline to End of Study (up to Day 365)

  3. Percent Change from Baseline Total Cholesterol

    Time frame: Baseline to End of Study (up to Day 365)

  4. Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)

    Time frame: Baseline to End of Study (up to Day 365)

  5. Percent Change from Baseline in Apolipoprotein B

    Time frame: Baseline to End of Study (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 2, Randomized, Double-Blind, Placebo-Controlled Study of VERVE-102, a One-Time Dose Gene Editing Medicine, in Adults With or at High Risk for Atherosclerotic Cardiovascular Disease (ASCVD) Who Require Additional Low-Density Lipoprotein-Cholesterol (LDL-C) Lowering

Acronym: HEART-3

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Sep 24, 2026
Registry last updated
Sep 24, 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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