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 evaluted 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 standard 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 in Fasting Triglycerides (TG) at Week 24
Time frame: Baseline, Week 24
Percent Change from Baseline in Fasting TG
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 36, Week 48
Percent Change from Baseline in Apolipoprotein (APO) C-III at Week 24
Time frame: Baseline, Week 24
Percent Change from Baseline in APOC-III Over Time
Time frame: Baseline, up to Week 48
Percent Change from Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
Time frame: Baseline, Week 24
Percent Change form Baseline in Non-HDL-C Over Time
Time frame: Baseline, up to Week 48
Percent Change from Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 24
Time frame: Baseline, Week 24
Percent Change from Baseline in HDL-C Over Time
Time frame: Baseline, up to Week 48
Percent Change from Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24
Time frame: Baseline, Week 24
Percent Change from Baseline in ApoB Over Time
Time frame: Baseline, up to Week 48
Percent Change from Baseline in Fasting Total Low Density Lipoprotein Cholesterol (LDL-C) Using Ultracentrifugation at Week 24
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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
Time frame: Baseline, Week 24
Percent Change from Baseline in Fasting Total LDL-C Using Ultracentrifugation Over Time
Time frame: Baseline, up to Week 48
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Week 24
Time frame: Week 24
Number of Participants with Treatment- Emergent AEs and/or SAEs Through Week 48
Time frame: up to Week 48
Change from Baseline in Plasma Concentrations of ARO-APOC3 Over Time
Time frame: up to Week 24
Pharmacokinetics (PK) of ARO-APOC3: Maximum Observed Plasma Concentration (Cmax)
Time frame: up to Week 24
PK of ARO-APOC3: Time to Maximum Plasma Concentration (Tmax)
Time frame: up to Week 24
PK of ARO-APOC3: Area Under the Plasma Concentration Versus Time Curve From Zero to Time of Last Measurable Concentration (AUClast)
Time frame: up to Week 24