RECRUITING

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

Description

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.

Conditions

Elevated Lp(a)Atherosclerotic Cardiovascular Disease (ASCVD)
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Related Conditions:

Elevated Lp(a)Atherosclerotic Cardiovascular Disease (ASCVD)

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Elevated Lp(a)
Intervention / Treatment

-

Contacts and Locations

Concord

John Muir Medical Center - Concord Campus, Concord, California, United States, 94520

Fountain Valley

Ark Clinical Research - Fountain Valley, Fountain Valley, California, United States, 92708

Redding

The Cardiovascular Center, Redding, California, United States, 96001

Colorado Springs

Legacy Clinical Trials, Colorado Springs, Colorado, United States, 80909

Golden

OptumCare Clinical Trials, LLC, Golden, Colorado, United States, 80401

Boca Raton

FWD Clinical Research, Boca Raton, Florida, United States, 33486

Hollywood

Soffer Health Institute, Hollywood, Florida, United States, 33020

Augusta

Masters of Clinical Research, Augusta, Georgia, United States, 30909

Scarborough

MaineHealth Cardiology, Scarborough, Maine, United States, 04074

Columbia

Johns Hopkins University, Columbia, Maryland, United States, 21044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2031-03