Muvalaplin to lower major heart and stroke events in adults with high 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
This study tests whether muvalaplin can lower the chance of heart attack, stroke, or other major cardiovascular events in adults with high lipoprotein(a) who have or are at risk for cardiovascular disease.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 10450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 754 sites (Gilbert, Arizona and 753 other locations) |
| Trial ID | NCT07157774 on ClinicalTrials.gov |
What this trial studies
This phase 3, randomized, placebo-controlled trial will enroll adults with Lp(a) ≥175 nmol/L who either have had an ASCVD event within the past 10 years or are at high risk for a first event. Participants will be randomized to receive muvalaplin or placebo and followed with regular visits to track major cardiovascular events and safety. The primary comparison is the rate of major adverse cardiovascular events between the muvalaplin and placebo groups over the follow-up period. Eli Lilly is sponsoring the multicenter trial with enrollment at several clinical sites in Arizona.
Who should consider this trial
Good fit: Adults with Lp(a) ≥175 nmol/L who have had an ASCVD event within the last 10 years or who have high-risk features for a first event (such as documented CAD, carotid stenosis, PAD, a high coronary artery calcium score, or diabetes with reduced kidney function) are ideal candidates.
Not a fit: People with Lp(a) below 175 nmol/L, those who had a major cardiovascular event or surgery within 90 days, or those planning such procedures are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, muvalaplin could reduce heart attacks, strokes, and other major cardiovascular events in people with elevated Lp(a).
How similar studies have performed: Other Lp(a)-lowering therapies have produced large Lp(a) reductions, but proof that lowering Lp(a) reduces heart attacks and strokes is not yet established, making this phase 3 outcome trial important.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gilbert, Arizona and 753 other locations
- Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC — Gilbert, Arizona, United States (Not_yet_recruiting)
- Axsendo Clinical Research - Peak Heart & Vascular - Phoenix — Phoenix, Arizona, United States (Recruiting)
- Clinical Research Institute of Arizona (CRI) - Sun City West — Sun City West, Arizona, United States (Not_yet_recruiting)
- Southwest Kidney Institute - Surprise — Surprise, Arizona, United States (Recruiting)
- Pima Heart — Tucson, Arizona, United States (Not_yet_recruiting)
- National Heart Institute — Beverly Hills, California, United States (Not_yet_recruiting)
- John Muir Medical Center - Concord Campus — Concord, California, United States (Recruiting)
- Neighborhood Healthcare Institute of Health — Escondido, California, United States (Not_yet_recruiting)
- Ark Clinical Research - Fountain Valley — Fountain Valley, California, United States (Recruiting)
- Care Access - Huntington Beach — Huntington Beach, California, United States (Not_yet_recruiting)
- The Cardiovascular Center — Redding, California, United States (Recruiting)
- UCLA South Bay Endocrinology — Torrance, California, United States (Not_yet_recruiting)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Not_yet_recruiting)
- Legacy Clinical Trials — Colorado Springs, Colorado, United States (Recruiting)
- OptumCare Clinical Trials, LLC — Golden, Colorado, United States (Not_yet_recruiting)
- Cardiology Associates of Fairfield County, P.C. — Stamford, Connecticut, United States (Not_yet_recruiting)
- Chase Medical Research, LLC — Waterbury, Connecticut, United States (Not_yet_recruiting)
- Excel Medical Clinical Trials — Boca Raton, Florida, United States (Not_yet_recruiting)
- FWD Clinical Research — Boca Raton, Florida, United States (Recruiting)
- American Research Institute — Cutler Bay, Florida, United States (Recruiting)
- K2 Medical Research - Daytona Beach — Daytona Beach, Florida, United States (Not_yet_recruiting)
- Arrow Clinical Trials — Daytona Beach, Florida, United States (Recruiting)
- Soffer Health Institute — Hollywood, Florida, United States (Recruiting)
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (Not_yet_recruiting)
- K2 MEDICAL Research THE VILLAGES — Lady Lake, Florida, United States (Recruiting)
- K2 Medical Research - Maitland — Maitland, Florida, United States (Recruiting)
- K2 Medical Research ORLANDO — Maitland, Florida, United States (Recruiting)
- Dade Florida Clinical Research Center — Miami, Florida, United States (Recruiting)
- Onhealth Research Center — Miami, Florida, United States (Recruiting)
- Advanced Research for Health Improvement, LLC — Naples, Florida, United States (Not_yet_recruiting)
- Renstar Medical Research — Ocala, Florida, United States (Not_yet_recruiting)
- Care Access - Tamarac — Tamarac, Florida, United States (Recruiting)
- Care Access - Tampa — Tampa, Florida, United States (Recruiting)
- Southeastern Clinical Research Institute — Augusta, Georgia, United States (Not_yet_recruiting)
- Masters of Clinical Research — Augusta, Georgia, United States (Recruiting)
- Center for Advanced Research & Education — Gainesville, Georgia, United States (Not_yet_recruiting)
- North Georgia Clinical Research — Woodstock, Georgia, United States (Not_yet_recruiting)
- Elite Clinical Trials — Blackfoot, Idaho, United States (Recruiting)
- CARE Institute - High Desert — Meridian, Idaho, United States (Not_yet_recruiting)
- Elite Clinical Trials — Rexburg, Idaho, United States (Recruiting)
- Great Lakes Clinical Trials - Ravenswood — Chicago, Illinois, United States (Not_yet_recruiting)
- AMR Clinical — Niles, Illinois, United States (Not_yet_recruiting)
- IU Health Bloomington — Bloomington, Indiana, United States (Not_yet_recruiting)
- Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States (Not_yet_recruiting)
- Tulane University School of Medicine — New Orleans, Louisiana, United States (Not_yet_recruiting)
- MaineHealth Cardiology — Scarborough, Maine, United States (Recruiting)
- Ascension Saint Agnes Heart Care — Baltimore, Maryland, United States (Not_yet_recruiting)
- Metropolitan Cardiovascular Consultants — Beltsville, Maryland, United States (Not_yet_recruiting)
- Flourish Research - Bowie — Bowie, Maryland, United States (Not_yet_recruiting)
- Johns Hopkins University — Columbia, Maryland, United States (Recruiting)
+704 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.