Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT07157774
NCT07157774RecruitingPhase 3

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

Eli Lilly and Company1404 sites in 3 countries10,450 target enrollmentStarted: September 2, 2025Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
10,450
Locations
1,404
Primary Endpoint
Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Placebo

Placebo Comparator

Participants will receive placebo orally.

Intervention: Placebo (Drug)

Muvalaplin

Experimental

Participants will receive muvalaplin orally.

Intervention: Muvalaplin (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 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.

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

Time Frame: 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.

Secondary Outcomes

  • Time to First Occurrence of Any Component of the MACE-3 Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
  • Time to First Occurrence of Any Component of the Modified MACE-3 Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
  • Time to Occurrence of All-Cause Mortality(Baseline up to End of Study (About 5.25 Years))
  • Time to First Occurrence of Each Individual Component of the MACE-4 Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
  • 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))
  • Time to First Occurrence of Any Component of the Modified MACE-3 Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
  • Time to First Occurrence of Any Component of the Coronary MACE-3 Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
  • Time to First Occurrence of Any Component of MACE-3 + Major Adverse Limb Event (MALE) Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
  • Time to Occurrence of All-Cause Mortality(Baseline up to End of Study (About 5.25 Years))
  • Change from Baseline to Each Annual Visit for Health-Care Resource Utilization (HCRU)(Baseline up to End of Study (About 5.25 Years))
  • Time to First Occurrence of Each Individual Component of the MACE-4 Composite Endpoint(Baseline up to End of Study (About 5.25 Years))
  • Pharmacokinetics (PK): Trough Concentration at Steady State (C-trough, ss) of Muvalaplin(Predose through Week 96)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1404)

Loading locations...

Similar Trials

Completed
Phase 3
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVDCardiovascular Disease and Lipoprotein(a)
NCT04023552Novartis Pharmaceuticals8,323
Recruiting
Phase 3
Assessing the Impact of TQJ230 in reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
CTRI/2020/07/026538Novartis Healthcare Pvt Ltd7,680
Completed
Phase 3
Safety and Efficacy Study of Roxadustat with compare to Placebo for treatment of Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis
CTRI/2015/12/006412AstraZeneca AB2,600
Recruiting
Phase 3
Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation
NCT06830798Alexion Pharmaceuticals, Inc.450
Unknown
Phase 3
A Clinical Trial to Evaluate the Safety and Efficacy ofApixaban In Subjects with a Recent Acute Coronary SyndromeAcute Coronary Syndrome
CTRI/2009/091/000249BristolMyers Squibb1,080