Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia

Completed · Phase 2 · Has a placebo group

Conditions studied: Severe Hypertriglyceridemia

In brief

The purpose of AROAPOC3-2001 is to evaluate the efficacy and safety of ARO-APOC3 in participants with severe hypertriglyceridemia. Participants will receive 2 subcutaneous injections of ARO-APOC3.

Key facts

Study ID

NCT04720534

Run by

Arrowhead Pharmaceuticals

People needed

229

Starts

2021-05-31

Expected to finish

2023-08-31

Last updated by the study team

2026-03-24

Who can join

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

You may qualify if…

• Based on medical history, evidence of triglycerides (TG) ≥ 500 mg/dL and ≤ 4000 mg/dL at Screening
• Fasting TG ≥ 500 mg/dL at Screening
• Willing to follow diet counseling per Investigator judgment based on local standard of care
• Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
• Willing to provide written informed consent and to comply with study requirements

You may not qualify if…

• Active pancreatitis within 12 weeks prior to first dose
• Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
• Acute coronary syndrome event within 24 weeks of first dose
• Major surgery within 12 weeks of first dose
• Planned coronary intervention (e.g., stent placement or heart bypass) or any non-cardiac major surgical procedure throughout the study
• Uncontrolled hypertension
• Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
• Uncontrolled hypothyroidism or hyperthyroidism
• Hemorrhagic stroke within 24 weeks of first dose
• Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)
• Note: additional inclusion/exclusion criteria may apply per protocol

Where it is running

• Research Site 4 — Palm Springs, California, United States
• Research Site 5 — Boca Raton, Florida, United States
• Research Site 6 — Fort Lauderdale, Florida, United States
• Research Site 10 — Miami, Florida, United States
• Research Site 9 — Miami, Florida, United States
• Research Site 11 — Miami, Florida, United States
• Research Site 8 — Miami, Florida, United States
• Research Site 12 — Miami Springs, Florida, United States
• Research Site 14 — Port Orange, Florida, United States
• Research Site 16 — Dunwoody, Georgia, United States
• Research Site 17 — Arlington Heights, Illinois, United States
• Research Site 18 — Lexington, Kentucky, United States
• Research Site 20 — Minneapolis, Minnesota, United States
• Research Site 21 — Tupelo, Mississippi, United States
• Research Site 22 — Kalispell, Montana, United States
• Research Site 23 — Omaha, Nebraska, United States
• Research Site 24 — Las Vegas, Nevada, United States
• Research Site 25 — Long Island City, New York, United States
• Research Site 26 — New Windsor, New York, United States
• Research Site 27 — New York, New York, United States
• Research Site 29 — Morehead City, North Carolina, United States
• Research Site 30 — Fargo, North Dakota, United States
• Research Site 31 — Dayton, Ohio, United States
• Research Site 32 — Franklin, Ohio, United States
• Research Site 2 — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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