Health Trials

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

ConditionsElevated Lp(a)Atherosclerotic Cardiovascular Disease (ASCVD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have Lp(a) ≥175 nanomoles per liter (nmol/L)

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

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Muvalaplin

    Drug

    Administered orally

  • Placebo

    Drug

    Administered orally

Treatment groups

10,450 Participants
are divided into 2 treatment groups
Group A: MuvalaplinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline up to End of Study (About 5.25 Years)

Secondary outcomes

1

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

Time frame
Baseline, Week 4
2

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

Time frame
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

Time frame
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

Time frame
Baseline up to End of Study (About 5.25 Years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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