NCT07839936

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for phase_2

Timeline
42mo left

Started Oct 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

1.8 years

First QC Date

September 18, 2026

Last Update Submit

September 18, 2026

Conditions

AtherosclerosisCardiovascular DiseaseHypercholesterolemia

Keywords

Heterozygous Familial HypercholesterolemiaLDL cholesterolHigh cholesterolCardiovascular risk factorsCoronary Artery DiseaseHeart attackStrokeBase editing

Outcome Measures

Primary Outcomes (1)

  • Percent Change from Baseline in LDL-C

    Baseline, Day 90

Secondary Outcomes (5)

  • Percent Change from Baseline in LDL-C

    Baseline to End of Study (up to Day 365)

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

    Baseline to End of Study (up to Day 365)

  • Percent Change from Baseline Total Cholesterol

    Baseline to End of Study (up to Day 365)

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

    Baseline to End of Study (up to Day 365)

  • Percent Change from Baseline in Apolipoprotein B

    Baseline to End of Study (up to Day 365)

Study Arms (4)

VERVE-102 Dose 1

EXPERIMENTAL

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

Drug: VERVE-102

VERVE-102 Dose 2

EXPERIMENTAL

Participants will receive a single dose of VERVE-102 IV

Drug: VERVE-102

VERVE-102 Dose 3

EXPERIMENTAL

Participants will receive a single dose of VERVE-102 IV

Drug: VERVE-102

Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of placebo IV

Drug: Placebo

Interventions

VERVE-102DRUG

Administered IV

Also known as: LY4636581
VERVE-102 Dose 1VERVE-102 Dose 2VERVE-102 Dose 3
PlaceboDRUG

Administered IV

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Epic Medical Research

DeSoto, Texas, 75115, United States

Location

MeSH Terms

Conditions

AtherosclerosisCardiovascular DiseasesHypercholesterolemiaCoronary Artery DiseaseMyocardial InfarctionStroke

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

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

CONTACT

317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 24, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

March 1, 2030

Last Updated

September 24, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
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.
More information

Locations

US(1)