Lipoprotein(a), also known as Lp(a), is a protein that carries cholesterol and proteins in your blood. People with high Lp(a) have a higher risk for heart disease. The main purpose of the study is to investigate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the heart's vessels using an imaging technology known as Coronary Computed Tomography Angiography (CCTA) in adults who have high levels of Lp(a). Participation will last about 120 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
252
Administered SC
Administered SC
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, United States
NOT_YET_RECRUITINGValley Clinical Trials, Inc.
Northridge, California, United States
RECRUITINGLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
RECRUITINGJellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
Percent Change from Baseline in Noncalcified Plaque (NCP) Volume
Time frame: Baseline, Week 104
Percent Change from Baseline in Mean Fat Attenuation Index (FAI) Score
Time frame: Baseline, Week 104
Percent Change from Baseline in Lp(a) Level
Time frame: Baseline through Week 104
Percentage of Participants Reporting Strongly Agree or Agree on the Subcutaneous Administration Assessment Questionnaire (SQAAQ) Version 3.0 Items
Time frame: Week 26, Week 78
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3819469
Time frame: Predose through Week 52
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
RECRUITINGMerritt Island Medical Research, LLC
Merritt Island, Florida, United States
RECRUITINGInpatient Research Clinic
Miami Lakes, Florida, United States
RECRUITINGClinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States
RECRUITINGHigh Desert Heart & Vascular
Meridian, Idaho, United States
NOT_YET_RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITING...and 48 more locations