Participants who have met all protocol eligibility criteria will be randomly assigned to treatment (ARO-APOC3 or placebo) in a double-blind fashion and will be evaluated for safety and efficacy over 48 weeks. Participants will be counseled to remain on a specified diet throughout the study, as recommended by the Investigator in accordance with local standards of care. After week 48, participants will be eligible and invited to consent and continue in an open-label extension study. All placebo participants who opt to continue will switch to active drug (ARO-APOC3) during the extension study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
353
Research Site 3
Percent Change From Baseline at Week 24 in Fasting TG
Least square (LS) mean and standard error (SE) were calculated using mixed model repeated measures (MMRM) which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Time frame: Baseline, Week 24
Percent Change From Baseline Over Time Through Week 48 in Fasting TG
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/early termination (ET)
Percent Change From Baseline at Week 24 in Apolipoprotein (Apo)C-III
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Time frame: Baseline, Week 24
Percent Change From Baseline Over Time Through Week 48 in ApoC-III
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ET
Percent Change From Baseline at Week 24 in Fasting Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Time frame: Baseline, Week 24
Percent Change From Baseline Over Time Through Week 48 in Fasting Non-HDL-C
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Beverly Hills, California, United States
Research Site 8
Northridge, California, United States
Research Site 2
Boca Raton, Florida, United States
Research Site 1
Fort Lauderdale, Florida, United States
Research Site 14
Miami Springs, Florida, United States
Research Site 5
Pembroke Pines, Florida, United States
Research Site 18
Dunwoody, Georgia, United States
Research Site 31
Las Vegas, Nevada, United States
Research Site 17
New Windsor, New York, United States
Research Site 12
Dayton, Ohio, United States
...and 20 more locations
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ET
Percent Change From Baseline at Week 24 in Fasting High-Density Lipoprotein Cholesterol (HDL-C)
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Time frame: Baseline, Week 24
Percent Change From Baseline Over Time Through Week 48 in Fasting HDL-C
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ET
Percent Change From Baseline at Week 24 in Fasting Total Apolipoprotein B (ApoB)
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Time frame: Baseline, Week 24
Percent Change From Baseline Over Time Through Week 48 in Fasting Total ApoB
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ET
Percent Change From Baseline at Week 24 in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C)
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Time frame: Baseline, Week 24
Percent Change From Baseline Over Time Through Week 48 in Fasting LDL-C
LS mean and SE were calculated using MMRM which included treatment arm, study visit, and baseline value as model terms and treatment by visit and treatment by baseline as interaction terms.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 48/ET
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence, which did not necessarily have to have a causal relationship with this treatment. A serious AE (SAE) was an AE that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or was a medically important event or reaction. TEAEs were AEs that occurred following study drug administration or a pre-existing condition exacerbated following study drug administration.
Time frame: Up to Week 48