AtherosclerosisPhase 2HEART-3NCT07839936
A Study of VERVE-102 (LY4636581) in Adults With or at High Risk for Cardiovascular Disease
A Phase 2 study testing VERVE-102 in people with Atherosclerosis and Cardiovascular Disease, run by Verve Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atherosclerosis, Cardiovascular Disease, Hypercholesterolemia
- What is being tested?
- VERVE-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established atherosclerotic cardiovascular disease (ASCVD) and/or at a high risk of ASCVD
Who cannot join
- History of confirmed or suspected homozygous familial hypercholesterolemia (HoFH)
- Chronic liver disease
- Current treatment with PCSK9 inhibitor or prior treatment within specified timeframe
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
About this study
Official 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
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.
- Being tested
- VERVE-102, Placebo
- Keywords
- Heterozygous Familial Hypercholesterolemia, LDL cholesterol, High cholesterol, Cardiovascular risk factors, Coronary Artery Disease, Heart attack, Stroke, Base editing
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Hypercholesterolemia, Coronary Artery Disease, Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERVE-102Drug
Also called LY4636581
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| VERVE-102 Dose 1 | Experimental | Participants will receive a single dose of VERVE-102 intravenously (IV) Receives: Drug: VERVE-102 |
| VERVE-102 Dose 2 | Experimental | Participants will receive a single dose of VERVE-102 IV Receives: Drug: VERVE-102 |
| VERVE-102 Dose 3 | Experimental | Participants will receive a single dose of VERVE-102 IV Receives: Drug: VERVE-102 |
| Placebo | Placebo comparator | Participants will receive a single dose of placebo IV Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in LDL-C
Measured: Baseline, Day 90
Secondary outcomes (5)
Percent Change from Baseline in LDL-C
Measured: Baseline to End of Study (up to Day 365)
Percent Change from Baseline in Circulating Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Measured: Baseline to End of Study (up to Day 365)
Percent Change from Baseline Total Cholesterol
Measured: Baseline to End of Study (up to Day 365)
Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)
Measured: Baseline to End of Study (up to Day 365)
Percent Change from Baseline in Apolipoprotein B
Measured: Baseline to End of Study (up to Day 365)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verve Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839936
- Sponsor's protocol ID
- 27851
- Other IDs
- J7D-MC-ENCA, 2026-525691-26-00
- Acronym
- HEART-3
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07839936
- Acronym / sponsor ID
- HEART-3 / 27851
- Keywords
- Heterozygous Familial Hypercholesterolemia, LDL cholesterol, High cholesterol, Cardiovascular risk factors, Coronary Artery Disease, Heart attack, Stroke, Base editing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Verve Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VERVE-102 Dose 1 | Experimental | Drug: VERVE-102Participants will receive a single dose of VERVE-102 intravenously (IV) |
| VERVE-102 Dose 2 | Experimental | Drug: VERVE-102Participants will receive a single dose of VERVE-102 IV |
| VERVE-102 Dose 3 | Experimental | Drug: VERVE-102Participants will receive a single dose of VERVE-102 IV |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of placebo IV |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Established atherosclerotic cardiovascular disease (ASCVD) and/or at a high risk of ASCVD
Key exclusion criteria (3 listed)
- History of confirmed or suspected homozygous familial hypercholesterolemia (HoFH)
- Chronic liver disease
- Current treatment with PCSK9 inhibitor or prior treatment within specified timeframe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VERVE-102Also: LY4636581Administered IV | Drug | VERVE-102 Dose 1, VERVE-102 Dose 2, VERVE-102 Dose 3 |
| PlaceboAdministered IV | Drug | Placebo |
Primary outcome
Percent Change from Baseline in LDL-C
Time frame: Baseline, Day 90
5 secondary outcomes
Percent Change from Baseline in LDL-C
Time frame: Baseline to End of Study (up to Day 365)
Percent Change from Baseline in Circulating Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Time frame: Baseline to End of Study (up to Day 365)
Percent Change from Baseline Total Cholesterol
Time frame: Baseline to End of Study (up to Day 365)
Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)
Time frame: Baseline to End of Study (up to Day 365)
Percent Change from Baseline in Apolipoprotein B
Time frame: Baseline to End of Study (up to Day 365)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VERVE-102 in people with Atherosclerosis and Cardiovascular Disease, run by Verve Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline in LDL-C (time frame: Baseline, Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.