Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Arrowhead Pharmaceuticals

Criteria

Inclusion Criteria:

• Based on medical history, evidence of TG ≥ 500 mg/dL

• 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

Exclusion Criteria:

• 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