This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by FDG-PET/CT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
147
Unnamed facility
Torrance, California, United States
Unnamed facility
Colorado Springs, Colorado, United States
Change in TBR as measured by FDG-PET/CT
Time frame: Baseline to Week 12
Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLDL1278A
Time frame: Throughout study or until early discontinuation
Effects of MLDL1278A on inflammatory and metabolic biomarkers
Time frame: Throughout study or until early discontinuation
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Repeating oral dose
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Gainesville, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Haverhill, Massachusetts, United States
Unnamed facility
Royal Oak, Michigan, United States
Unnamed facility
Minneapolis, Minnesota, United States
...and 14 more locations