NCT05413135

Study of ARO-APOC3 in Adults With Dyslipidemia

A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults With Dyslipidemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 418 (actual)
• Sponsor: Arrowhead Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyslipidemias

Interventions

Type	Name	Description
DRUG	ARO-APOC3	ARO-APOC3 Injection

Timeline

• Start date: 2022-07-07
• Primary completion: 2025-09-18
• Completion: 2025-09-18
• First posted: 2022-06-09
• Last updated: 2025-12-17

Locations

60 sites across 7 countries: United States, Australia, Canada, Hungary, Netherlands, New Zealand, Poland

Regulatory

• FDA-regulated drug study