RECRUITING

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

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Conditions

Elevated Lp(a)Atherosclerotic Cardiovascular Disease (ASCVD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-09-02
Study Completion:2031-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07157774

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have Lp(a) ≥175 nanomoles per liter (nmol/L)
  2. * Meet one of the following criteria:
  3. * 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
  4. * Are at risk for a first ASCVD event, defined as one or more of the following:
  5. * Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without a history of ASCVD event
  6. * A high coronary artery calcium (CAC) score
  7. * Reduced kidney function with diabetes
  8. * Combination(s) of high risk factors
  1. * 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
  2. * Are planning or expected to undergo a procedure to restore blood flow in the arteries or a major heart surgery during the study
  3. * Have uncontrolled high blood pressure
  4. * Have New York Heart Association (NYHA) class III or IV heart failure
  5. * Have undergone a procedure to remove cholesterol from the blood within 90 days of screening, or have a planned procedure during the study
  6. * Have severe kidney impairment
  7. * Have had cancer within 5 years prior to screening

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
clinical_inquiry_hub@lilly.com

Principal Investigator

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 Locations (Sites)

John Muir Medical Center - Concord Campus
Concord, California, 94520
United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California, 92708
United States
The Cardiovascular Center
Redding, California, 96001
United States
Legacy Clinical Trials
Colorado Springs, Colorado, 80909
United States
OptumCare Clinical Trials, LLC
Golden, Colorado, 80401
United States
FWD Clinical Research
Boca Raton, Florida, 33486
United States
Soffer Health Institute
Hollywood, Florida, 33020
United States
Masters of Clinical Research
Augusta, Georgia, 30909
United States
MaineHealth Cardiology
Scarborough, Maine, 04074
United States
Johns Hopkins University
Columbia, Maryland, 21044
United States
Lucida Clinical Trials
New Bedford, Massachusetts, 02740
United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121
United States
Capital Cardiology Associates
Albany, New York, 12211
United States
NYC Research
New York, New York, 10016
United States
Weill Cornell Medical College
New York, New York, 10021
United States
Southgate Medical Group
West Seneca, New York, 14224
United States
Kaiser Permanente Sunnyside Medical Center
Clackamas, Oregon, 97015
United States
M3 Wake Research - Charleston
Charleston, South Carolina, 29414
United States
WR-Clinsearch, LLC
Chattanooga, Tennessee, 37397
United States
The Jackson Clinic
Jackson, Tennessee, 38305
United States
Lifedoc Research - Lenox Park Drive
Memphis, Tennessee, 38115
United States
St. David's Heart & Vascular PLLC dba Austin Heart
Austin, Texas, 78756
United States
Southwest Family Medicine Associates
Dallas, Texas, 75235
United States
IntraCare
Dallas, Texas, 75254
United States
GMG Clinical Research (DBA Radiance Clinical Research) - Lampasas
Lampasas, Texas, 76550
United States
Ogden Clinic - Canyon View
Ogden, Utah, 84404
United States
Carient Heart & Vascular - Manassas
Manassas, Virginia, 20109
United States
Manassas Clinical Research Center
Manassas, Virginia, 20110
United States
TPMG (Tidewater Physicians Multispecialty Group) Clinical Research
Newport News, Virginia, 23606
United States
York Clinical Research
Norfolk, Virginia, 23504
United States
Dominion Medical Associates, Inc.
Richmond, Virginia, 23219
United States
Carilion Clinic
Roanoke, Virginia, 24014
United States
Rainier Clinical Research Center
Renton, Washington, 98057
United States
Universal Research Group
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-02
Study Completion Date2031-03

Study Record Updates

Study Start Date2025-09-02
Study Completion Date2031-03

Terms related to this study

Additional Relevant MeSH Terms

  • Elevated Lp(a)
  • Atherosclerotic Cardiovascular Disease (ASCVD)