Dyslipidemias
Conditions
Brief summary
This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continued to meet eligibility criteria had the option to be enrolled into this study. Eligible enrolled participants initially received open-label ARO-APOC3 every three or six months at the assigned dose level of the parent study until a final dose of 25 mg was selected, at which point all participants transitioned to the selected dosing regimen of 25 mg every 3 months.
Interventions
DRUGARO-APOC3
ARO-APOC3 Injection
Sponsors
Arrowhead Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults who are nonpregnant, nonlactating and do not plan to become pregnant during the study * Able and willing to provide written informed consent * Completed the 48-week study treatment period in the parent study
Exclusion criteria
* Subject was permanently discontinued from ARO-APOC3 in the parent study due to elevated glycated hemoglobin (HbA1c), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) * Any new condition or worsening of existing condition or any other situation that 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 * Unwilling to limit alcohol consumption to within moderate limits for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Through 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Fasting Triglycerides (TG) Over Time | Through 24 months |
| Percent Change from Baseline in Fasting TG Over Time | Through 24 months |
| Change from Baseline in Apolipoprotein (Apo) C-III Over Time | Through 24 months |
| Percent Change from Baseline in ApoC-III Over Time | Through 24 months |
| Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Over Time | Through 24 months |
| Percent Change from Baseline in Fasting Non-HDL-C Over Time | Through 24 months |
| Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time | Through 24 months |
| Percent Change from Baseline in Fasting HDL-C Over Time | Through 24 months |
| Change from Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time | Through 24 months |
| Percent Change from Baseline in Fasting Total ApoB Over Time | Through 24 months |
| Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation | Through 24 months |
| Percent Change from Baseline in Fasting LDL-C Over Time Using Ultracentrifugation | Through 24 months |
Countries
Australia, Canada, Hungary, Netherlands, New Zealand, Poland, United States
Outcome results
None listed