ClinicalTrials.gg
RecruitingNCT07839936HEART-3Updated Nov 10, 2026

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

A Phase 2 interventional study of VERVE-102 and Placebo in Atherosclerosis, Cardiovascular Disease and Hypercholesterolemia, sponsored by Verve Therapeutics, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Verve Therapeutics, Inc. (part of Eli Lilly and Company) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 10, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
175
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Atherosclerosis
  • Cardiovascular Disease
  • Hypercholesterolemia

Keywords

  • Heterozygous Familial Hypercholesterolemia
  • LDL cholesterol
  • High cholesterol
  • Cardiovascular risk factors
  • Coronary Artery Disease
  • Heart attack
  • Stroke
  • Base editing
03

In context

Atherosclerosis

1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.

This study's planned enrollment of 175 is above the median of 100 across 879 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Verve Therapeutics, Inc. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

First submitted after Verve Therapeutics, Inc. became part of Eli Lilly and Company.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
175 participants (estimated)

Study arms

  • Experimental
    VERVE-102 Dose 1

    Participants will receive a single dose of VERVE-102 intravenously (IV)

    Drug: VERVE-102

  • Experimental
    VERVE-102 Dose 2

    Participants will receive a single dose of VERVE-102 IV

    Drug: VERVE-102

  • Experimental
    VERVE-102 Dose 3

    Participants will receive a single dose of VERVE-102 IV

    Drug: VERVE-102

  • Placebo comparator
    Placebo

    Participants will receive a single dose of placebo IV

    Drug: Placebo

Interventions

  • DrugVERVE-102

    Administered IV

    Also known as: LY4636581

  • DrugPlacebo

    Administered IV

06

What researchers measure

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)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 10, 2026
Sites
Epic Medical Research is now Recruiting
Nov 10, 2026
Start date
Oct 2026→Sep 24, 2026 (actual)
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Not yet recruiting→Recruiting
    Epic Medical Research is now Recruiting
    Start date Oct 2026→Sep 24, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07839936
Responsible party
Sponsor
First posted
Sep 24, 2026
Start date
Sep 24, 2026
Primary completion
Aug 2028 (estimated)
Completion
Mar 2030 (estimated)
Last update
Nov 10, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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