Testing Muvalaplin against a placebo for elevated lp(a)
Official title: Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)
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
- Phase 3
- 2 groups
- Sites in Chicoutimi, Etobicoke and 12 more cities
- Recruiting
Interventions
- Medication
Muvalaplin
Administered orally
- Medication
Placebo
Administered orally
Canadian Sites (17)
17 of 17 recruiting
- Recruiting
Ecogene-21
Chicoutimi
- Recruiting
Riverside Cardiology and Diagnostic Imaging
Etobicoke
- Recruiting
Winterberry Research Inc.
Hamilton
- Recruiting
Diex Recherche Inc. Division Joliette
Joliette
- Recruiting
Viacar Recherche Clinique
Longueuil
- Recruiting
G A Research Associates
Moncton
- Recruiting
Institut de Cardiologie de Montreal
Montreal
- Recruiting
North York Diagnostic and Cardiac Centre
North York
- Recruiting
IUCPQ
Québec
- Recruiting
Bluewater Clinical Research Group Inc.
Sarnia
- Recruiting
KMH Cardiology Centres - Stoney Creek
Stoney Creek
- Recruiting
Unity Health Toronto, St. Michael's Hospital
Toronto
- Recruiting
Diex Recherche Inc. Division Trois-Rivieres
Trois-Rivières
- Recruiting
Victoria Heart Institute Foundation
Victoria
- Recruiting
Discovery Clinical Services
Victoria
- Recruiting
Fadia El Boreky Medicine
Waterloo
- Recruiting
Clinical Research Solutions - Kitchener
Waterloo
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- +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
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, or have a planned procedure during the study
- −Have severe kidney impairment
- −Have had cancer within 5 years prior to screening
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −Are planning or expected to undergo a procedure to restore blood flow in the arteries or a major heart surgery during the study
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Muvalaplin.
Registry label: A: Muvalaplin
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 10,450 people.
The study is currently expected to finish around March 2031.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to End of Study (About 5.25 Years).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite EndpointEndpointThe specific thing a study measures to answer its question.Read more → — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to End of Study (About 5.25 Years).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07157774 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About MuvalaplinDrug
Administered orally
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Administered orally
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to End of Study (About 5.25 Years).
The study as a whole is currently expected to finish around 2031-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 10,450 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 29 locations, including: Chicoutimi, Canada; Etobicoke, Canada; Hamilton, Canada; Joliette, Canada; Longueuil, Canada; Moncton, Canada, and 23 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (15)
Revival Research Institute, LLC
Dearborn, Michigan, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Boeson Research MSO
Missoula, Montana, United States
Capital Cardiology Associates
Albany, New York, United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, United States
NYC Research
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Southgate Medical Group
West Seneca, New York, United States
ERA Health Research - CardioNow - Lynnwood
Lynnwood, Washington, United States
Eastside Research Associates
Redmond, Washington, United States
Rainier Clinical Research Center
Renton, Washington, United States
Universal Research Group
Tacoma, Washington, United States
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.