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AROAPOC3-2001

Trial Overview

Official Title

A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Severe Hypertriglyceridemia

Study Purpose

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.

Diagnosis

Severe Hypertriglyceridemia

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  1. Active pancreatitis within 12 weeks prior to first dose
  2. Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
  3. Acute coronary syndrome event within 24 weeks of first dose
  4. Major surgery within 12 weeks of first dose
  5. Planned coronary intervention (e.g., stent placement or heart bypass) or any non-cardiac major surgical procedure throughout the study
  6. Uncontrolled hypertension
  7. Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
  8. Uncontrolled hypothyroidism or hyperthyroidism
  9. Hemorrhagic stroke within 24 weeks of first dose
  10. 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

Intervention

Drug: ARO-APOC3

Drug: Placebo

Parallel Assignment

For more information, visit ClinicalTrials.gov 

Key Participation Requirements
Trial Location(s)
Gender
Male or Female
Age
18 years and older
Enrollment Status
Recruiting
Phase
Phase II
Methodist Health System Trial Code
NCT04720534