Study of ARO-APOC3 in Adults With Dyslipidemia
- Registration Number
- NCT05413135
- Lead Sponsor
- Arrowhead Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 418
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ARO-APOC3 ARO-APOC3 1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 months
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Through 24 months
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Fasting HDL-C Over Time Through 24 months Change from Baseline in Fasting Triglycerides (TG) 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 Apolipoprotein (Apo) C-III 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 TG 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 Percent Change from Baseline in ApoC-III 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
Trial Locations
- Locations (60)
Clinical Research Site 1
🇺🇸Beverly Hills, California, United States
Clinical Research Site 2
🇺🇸Northridge, California, United States
Clinical Research Site 3
🇺🇸Palm Springs, California, United States
Clincal Research Site 4
🇺🇸Boca Raton, Florida, United States
Clinical Research Site 5
🇺🇸Fort Lauderdale, Florida, United States
Clinical Research Site 8
🇺🇸Miami, Florida, United States
Clinical Research Site 6
🇺🇸Miami, Florida, United States
Clinical Research Site 9
🇺🇸Miami Springs, Florida, United States
Clinical Research Site 10
🇺🇸Pembroke Pines, Florida, United States
Clinical Research Site 11
🇺🇸Port Orange, Florida, United States
Scroll for more (50 remaining)Clinical Research Site 1🇺🇸Beverly Hills, California, United States