Atherosclerotic Cardiovascular Disease (ASCVD), Elevated Lp(a)
Conditions
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.
Interventions
DRUGMuvalaplin
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Any Component of the MACE-3 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 |
| Percent Change from Baseline in Lipoprotein(a) (Lp(a)) at Week 4 | Baseline, Week 4 |
| Time to First Occurrence of Each Individual Component of the MACE-4 Composite Endpoint | Baseline up to End of Study (About 5.25 Years) |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Romania, Singapore, Slovakia, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed