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

NCT07157774
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
10,450
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Lead sponsor
Eli Lilly and Company
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Start date
2025-09-02
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Number of sites
801
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Summary
The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.
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Acronym
MOVE-Lp(a)
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Short title
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)
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Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Had a Prior Atherosclerotic Cardiovascular Event or Are at Risk for a First Atherosclerotic Cardiovascular Event
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2031-03-01
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First posted
2025-09-05
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Registry last updated
2026-08-21
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Primary completion date
2031-03-01
clinicaltrials.gov
Start date
2025-09-02
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Participants
10,450
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Participant count basis
Estimated
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Planned participants
10,450
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Protocol amendments
0
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Number of sites
801
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07157774
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ClinicalTrials.gov ID
NCT07157774
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint

    Timeframe: Baseline up to End of Study (About 5.25 Years)

    Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization.

  1. Percent Change from Baseline in Lipoprotein(a) (Lp(a)) at Week 4

    Timeframe: Baseline, Week 4

  2. Time to First Occurrence of Any Component of the MACE-3 Composite Endpoint

    Timeframe: Baseline up to End of Study (About 5.25 Years)

  3. Time to First Occurrence of Any Component of the Modified MACE-3 Composite Endpoint

    Timeframe: Baseline up to End of Study (About 5.25 Years)

  4. Time to First Occurrence of Any Component of the Coronary MACE-3 Composite Endpoint

    Timeframe: Baseline up to End of Study (About 5.25 Years)

  5. Time to First Occurrence of Any Component of MACE-3 + Major Adverse Limb Event (MALE) Composite Endpoint

    Timeframe: Baseline up to End of Study (About 5.25 Years)

  6. Time to Occurrence of All-Cause Mortality

    Timeframe: Baseline up to End of Study (About 5.25 Years)

  7. Time to First Occurrence of Each Individual Component of the MACE-4 Composite Endpoint

    Timeframe: Baseline up to End of Study (About 5.25 Years)

  8. Change from Baseline to Each Annual Visit for Health-Care Resource Utilization (HCRU)

    Timeframe: Baseline up to End of Study (About 5.25 Years)

  9. Pharmacokinetics (PK): Trough Concentration at Steady State (C-trough, ss) of Muvalaplin

    Timeframe: Predose through Week 96

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Birmingham Clinical ResearchBirmingham, United StatesNot yet recruiting
  • Smiths Medical CenterApache Junction, United StatesNot yet recruiting
  • Phoenix Medical TrialsGilbert, United StatesNot yet recruiting
  • Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLCGilbert, United StatesRecruiting
  • Onyx Clinical ResearchPhoenix, United StatesRecruiting
  • Clinical Research Institute of Arizona (CRI) - Sun City WestSun City West, United StatesRecruiting
  • Southwest Kidney Institute - SurpriseSurprise, United StatesRecruiting
  • Pima HeartTucson, United StatesRecruiting
  • Eclipse Clinical ResearchTucson, United StatesNot yet recruiting
  • National Heart InstituteBeverly Hills, United StatesRecruiting
  • John Muir Medical Center - Concord CampusConcord, United StatesRecruiting
  • Neighborhood Healthcare Institute of HealthEscondido, United StatesRecruiting
  • Ark Clinical Research - Fountain ValleyFountain Valley, United StatesRecruiting
  • Thrive Clinical Research GroupGlendora, United StatesNot yet recruiting
  • Care Access - Huntington BeachHuntington Beach, United StatesRecruiting
  • Scripps Whittier Diabetes InstituteLa Jolla, United StatesNot yet recruiting
  • The Cardiovascular CenterRedding, United StatesRecruiting
  • FOMAT Medical Research - Santa MariaSanta Maria, United StatesNot yet recruiting
  • Integrated Clinical ResearchSherman Oaks, United StatesNot yet recruiting
  • UCLA South Bay EndocrinologyTorrance, United StatesRecruiting
  • University of Colorado Anschutz Medical CampusAurora, United StatesRecruiting
  • Legacy Clinical TrialsColorado Springs, United StatesRecruiting
  • OptumCare Clinical Trials, LLCGolden, United StatesCompleted
  • Cardiology Associates of Fairfield County, P.C.Stamford, United StatesRecruiting
  • Chase Medical Research, LLCWaterbury, United StatesRecruiting

And 776 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-521067-13-00
  • J2O-MC-EKBG
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)