Dyslipidemia severely high hypertriglyceridemia
Conditions
Interventions
Investigational Product, Dosage, and Mode of Administration:
The test formulation is active ARO-APOC3 administered SC. The active
pharmaceutical ingredient contained in ARO-APOC3 is a synthetic,
dou
Sponsors
Arrowhead Pharmaceuticals, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adults >=18 years of age who are nonpregnant, nonlactating, and do not plan to become pregnant during the study 2. Able and willing to provide written informed consent prior to the performance of any study specific procedures 3. Completed the 48-week study treatment period in the parent study
Exclusion criteria
Exclusion criteria: 1. Subject was permanently discontinued from ARO-APOC3 in the parent study due to elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2. Any new condition or worsening of existing condition (eg, renal, hematologic, gastrointestinal, endocrine, cardiovascular, pulmonary, immunologic, psychiatric) or any other situation that, in the Investigator*s judgment, would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements, or put the subject at additional safety risk 3. Unwilling to limit alcohol consumption to within moderate limits for the duration of the study, as follows: not more than 14 units per week (1 unit approximately corresponds to 80 mL of wine, 200 mL of beer, or 25 mL of 40% alcohol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: • Subject incidence of treatment-emergent adverse events (TEAEs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: • Change and percent change from baseline over time in fasting TG • Change and percent change from baseline over time in apolipoprotein (Apo)C-III • Change and percent change from baseline over time in fasting non-high-density lipoprotein cholesterol (non-HDL-C) • Change and percent change from baseline over time in fasting HDL-C • Change and percent change from baseline over time in fasting total apolipoprotein B (ApoB) • Change and percent change from baseline over time in fasting LDL-C using ultracentrifugation Exploratory: • Change and percent change from baseline over time in other fasting lipid parameters (total cholesterol, LDL-C measured using Martin-Hopkins methodology, LDL/HDL ratio, VLDL-C, apolipoprotein B 48 [ApoB-48], lipoprotein[a] [Lp{a}], apolipoprotein B 100 [ApoB-100], apolipoprotein C-II [ApoC-II], apolipoprotein A-I [ApoA-I], and apolipoprotein A-V [ApoA-V] [all values drawn after at least a 10-hour fast]) • Change from baseline over time in fasting serum blood glucose, hemoglobin A1c (HbA1c), homeostatic model assessment for insulin resistance, and C peptide • Change and percent change from baseline over time in high sensitivity C-reactive protein • Emergence of and titers of anti-drug antibodies to ARO-APOC3 over time • Incidence of positively adjudicated events of acute pancreatitis • Incidence of hospitalizations for abdominal pain • Subject incidence of emergent apheresis | — |
Countries
Netherlands
Outcome results
None listed