Assessing the Impact of Muvalaplin on Major Cardiovascula... | NCT07157774

Studies
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)

NCT07157774

Sponsor

Eli Lilly and Company

Status

Recruiting

Last Update Posted

Jul 7, 2026Actual

Enrollment

10,450Estimated

Phase

Phase 3

Conditions

Elevated Lp(a)
Atherosclerotic Cardiovascular Disease (ASCVD)

Interventions

Muvalaplin
Placebo

Countries

United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czechia
Denmark
France
Germany
Greece
Hungary
India
Italy
Japan
Mexico
Netherlands
Poland
Puerto Rico
Romania
Singapore
Slovakia
South Korea
Spain
Taiwan
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2025-521067-13-00	EU Trial (CTIS) Number
J2O-MC-EKBG	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2025Actual

Primary Completion Date

Mar 2031Estimated

Completion Date

Mar 2031Estimated

First Submitted Date

Aug 28, 2025

First Submission Date that Met QC Criteria

Sep 4, 2025

First Posted Date

Sep 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2026

Last Update Posted Date

Jul 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10,450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Muvalaplin	Experimental	Participants will receive muvalaplin orally.	Drug: Muvalaplin
Placebo	Placebo Comparator	Participants will receive placebo orally.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Muvalaplin	Drug	Administered orally	Muvalaplin	LY3473329

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint	Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization.	Baseline up to End of Study (About 5.25 Years)

Secondary Outcomes

Measure	Description	Time Frame
Percent Change from Baseline in Lipoprotein(a) (Lp(a)) at Week 4		Baseline, Week 4
Time to First Occurrence of Any Component of the MACE-3 Composite Endpoint		Baseline up to End of Study (About 5.25 Years)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have Lp(a) ≥175 nanomoles per liter (nmol/L)
Meet one of the following criteria:
- Have had a prior atherosclerotic cardiovascular disease (ASCVD) event (such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body) within 10 years prior to screening
- Are at risk for a first ASCVD event, defined as one or more of the following:
  - Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without a history of ASCVD event
  - A high coronary artery calcium (CAC) score
  - Reduced kidney function with diabetes
  - Combination(s) of high risk factors

Exclusion Criteria:

Have experienced a major cardiovascular event or surgery, such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body, within 90 days prior to screening or occurring between screening and randomization
Are planning or expected to undergo a procedure to restore blood flow in the arteries or a major heart surgery during the study
Have uncontrolled high blood pressure
Have New York Heart Association (NYHA) class III or IV heart failure
Have undergone a procedure to remove cholesterol from the blood within 90 days of screening, or have a planned procedure during the study
Have severe kidney impairment
Have had cancer within 5 years prior to screening

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or	Contact	1-317-615-4559		LillyTrials@Lilly.com
Physicians interested in becoming principal investigators please contact	Contact			clinical_inquiry_hub@lilly.com

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC	Recruiting	Gilbert	Arizona	85296	United States

Label	URL
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a) ( MOVE-Lp(a) )	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Data are available 6 months after the primary publication and 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.

URL

https://vivli.org/

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases