Status:
COMPLETED
Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia
Lead Sponsor:
Arrowhead Pharmaceuticals
Conditions:
Severe Hypertriglyceridemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Based on medical history, evidence of 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
Exclusion
- 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
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT04720534
Start Date
May 31 2021
End Date
August 31 2023
Last Update
October 3 2025
Active Locations (74)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site 2
Beverly Hills, California, United States, 90211
2
Research Site 4
Palm Springs, California, United States, 92292
3
Research Site 5
Boca Raton, Florida, United States, 33434
4
Research Site 6
Fort Lauderdale, Florida, United States, 33308