Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp\[a\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
281
Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Time frame: Baseline and Week 36
Percentage Change From Baseline in Lp(a) at Week 48
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Time frame: Baseline and Week 48
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Time frame: Baseline; Week 36 and Week 48
Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
Time frame: Baseline; Week 36 and Week 48
Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48
Pharmacokinetic blood draws were collected at one timepoint during the 6-12 and 24-72 hour flexible time windows and at Week 48. Lower limit of quantification (LLOQ) = 0.400 ng/mL. Values below the LLOQ were set to zero.
Time frame: Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins
Baltimore, Maryland, United States
New York University
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Crossroads Clinical Research Inc
Mooresville, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
...and 26 more locations