Clinical Trials in Poland / NCT07157774
Recruiting
Phase 3
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)
NCT07157774 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Elevated Lp(a)Atherosclerotic Cardiovascular Disease (ASCVD)
Investigational drug(s) / intervention(s)
MuvalaplinPlacebo
Muvalaplin: Administered orally
Placebo: Administered orally
Study summary
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
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
Primary outcome measure(s)
- Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint — Baseline up to End of Study (About 5.25 Years)
Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization.
Trial sites (804)
| Facility | City | Region | Status |
|---|---|---|---|
| Birmingham Clinical Research | Birmingham | Alabama | Not Yet Recruiting |
| Smiths Medical Center | Apache Junction | Arizona | Not Yet Recruiting |
| Phoenix Medical Trials | Gilbert | Arizona | Not Yet Recruiting |
| Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC | Gilbert | Arizona | Recruiting |
| Onyx Clinical Research | Phoenix | Arizona | Recruiting |
| Clinical Research Institute of Arizona (CRI) - Sun City West | Sun City West | Arizona | Recruiting |
| Southwest Kidney Institute - Surprise | Surprise | Arizona | Recruiting |
| Pima Heart | Tucson | Arizona | Recruiting |
| Eclipse Clinical Research | Tucson | Arizona | Recruiting |
| National Heart Institute | Beverly Hills | California | Recruiting |
| John Muir Medical Center - Concord Campus | Concord | California | Recruiting |
| Neighborhood Healthcare Institute of Health | Escondido | California | Recruiting |
| Ark Clinical Research - Fountain Valley | Fountain Valley | California | Recruiting |
| Thrive Clinical Research Group | Glendora | California | Not Yet Recruiting |
| Care Access - Huntington Beach | Huntington Beach | California | Recruiting |
| 310 Clinical Research | Inglewood | California | Not Yet Recruiting |
| Scripps Whittier Diabetes Institute | La Jolla | California | Not Yet Recruiting |
| The Cardiovascular Center | Redding | California | Recruiting |
| FOMAT Medical Research - Santa Maria | Santa Maria | California | Not Yet Recruiting |
| Integrated Clinical Research | Sherman Oaks | California | Not Yet Recruiting |
| UCLA South Bay Endocrinology | Torrance | California | Recruiting |
| Lynn Institute of Denver | Aurora | Colorado | Not Yet Recruiting |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | Recruiting |
| Legacy Clinical Trials | Colorado Springs | Colorado | Recruiting |
| OptumCare Clinical Trials, LLC | Golden | Colorado | Completed |
| Cardiology Associates of Fairfield County, P.C. | Stamford | Connecticut | Recruiting |
| Chase Medical Research, LLC | Waterbury | Connecticut | Recruiting |
| Excel Medical Clinical Trials | Boca Raton | Florida | Recruiting |
| FWD Clinical Research | Boca Raton | Florida | Completed |
| American Research Institute | Cutler Bay | Florida | Recruiting |
| K2 Medical Research - Daytona Beach | Daytona Beach | Florida | Recruiting |
| Arrow Clinical Trials | Daytona Beach | Florida | Recruiting |
| Soffer Health Institute | Hollywood | Florida | Recruiting |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | Recruiting |
| K2 MEDICAL Research THE VILLAGES | Lady Lake | Florida | Recruiting |
| Clinical Research of Central Florida | Lakeland | Florida | Not Yet Recruiting |
| K2 Medical Research - Maitland | Maitland | Florida | Recruiting |
| K2 Medical Research ORLANDO | Maitland | Florida | Recruiting |
| Dade Florida Clinical Research Center | Miami | Florida | Recruiting |
| Onhealth Research Center | Miami | Florida | Recruiting |
+ 764 more sites — see the full list on the official registry below.
More Eli Lilly and Company trials in Poland
A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)
Active, not recruiting
A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07157774 on ClinicalTrials.gov ↗ ← All trials in Poland