Study of ARO-APOC3 in Adults With Dyslipidemia

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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 continue to meet eligibility criteria have the option to be enrolled into this study. Eligible enrolled participants will initially receive open-label ARO-APOC3 at the dose level assigned in the parent study until a final dose is selected, at which point all participants will receive open-label ARO-APOC3 at the same dosing regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arrowhead Pharmaceuticals

Criteria

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 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