Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)
- Conditions
- Elevated Lp(a)Atherosclerotic Cardiovascular Disease (ASCVD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT07157774
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10450
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Muvalaplin Muvalaplin Participants will receive muvalaplin orally. Placebo Placebo Participants will receive placebo orally.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Lipoprotein(a) (Lp(a)) at Week 4 Baseline, Week 4 Time to First Occurrence of Any Component of the MACE-3 Composite Endpoint Baseline up to End of Study (About 5.25 Years) Time to First Occurrence of Any Component of the Modified MACE-3 Composite Endpoint Baseline up to End of Study (About 5.25 Years) Time to First Occurrence of Any Component of the Coronary MACE-3 Composite Endpoint Baseline up to End of Study (About 5.25 Years) Time to First Occurrence of Any Component of MACE-3 + Major Adverse Limb Event (MALE) Composite Endpoint Baseline up to End of Study (About 5.25 Years) Time to Occurrence of All-Cause Mortality Baseline up to End of Study (About 5.25 Years) Time to First Occurrence of Each Individual Component of the MACE-4 Composite Endpoint Baseline up to End of Study (About 5.25 Years) Change from Baseline to Each Annual Visit for Health-Care Resource Utilization (HCRU) Baseline up to End of Study (About 5.25 Years) Pharmacokinetics (PK): Trough Concentration at Steady State (C-trough, ss) of Muvalaplin Predose through Week 96
Trial Locations
- Locations (626)
John Muir Medical Center - Concord Campus
🇺🇸Concord, California, United States
Ark Clinical Research - Fountain Valley
🇺🇸Fountain Valley, California, United States
The Cardiovascular Center
🇺🇸Redding, California, United States
Legacy Clinical Trials
🇺🇸Colorado Springs, Colorado, United States
OptumCare Clinical Trials, LLC
🇺🇸Golden, Colorado, United States
FWD Clinical Research
🇺🇸Boca Raton, Florida, United States
Soffer Health Institute
🇺🇸Hollywood, Florida, United States
Masters of Clinical Research
🇺🇸Augusta, Georgia, United States
MaineHealth Cardiology
🇺🇸Scarborough, Maine, United States
Johns Hopkins University
🇺🇸Columbia, Maryland, United States
Scroll for more (616 remaining)John Muir Medical Center - Concord Campus🇺🇸Concord, California, United StatesMatthew DeVanePrincipal Investigator