Study of ARO-APOC3 in Adults With Dyslipidemia

Completed · Phase 2

Conditions studied: Dyslipidemias

In brief

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.

Key facts

Study ID

NCT05413135

Run by

Arrowhead Pharmaceuticals

People needed

418

Starts

2022-07-07

Expected to finish

2025-09-22

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Clinical Research Site 12 — Dunwoody, Georgia, United States
• Clinical Research Site 13 — Minneapolis, Minnesota, United States
• Clinical Research Site 14 — Tupelo, Mississippi, United States
• Clinical Research Site 15 — Omaha, Nebraska, United States
• Clinical Research Site 16 — Las Vegas, Nevada, United States
• Clinical Research Site 17 — Long Island City, New York, United States
• Clinical Research Site 18 — New Windsor, New York, United States
• Clinical Research Site 19 — New York, New York, United States
• Clinical Research Site 20 — Morehead City, North Carolina, United States
• Clinical Research Site 21 — Fargo, North Dakota, United States
• Clinical Research Site 22 — Marion, Ohio, United States
• Clinical Research Site 23 — Maumee, Ohio, United States
• Clinical Research Site 24 — Oklahoma City, Oklahoma, United States
• Clinical Research Site 25 — Greenville, South Carolina, United States
• Clinical Research Site 26 — Chattanooga, Tennessee, United States
• Clinical Research Site 1 — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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