Study of ARO-ANG3 in Adults With Mixed Dyslipidemia

• Status: Recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will receive 2 subcutaneous injections of ARO-ANG3 or placebo.

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

Details

• Lead Sponsor: Arrowhead Pharmaceuticals

Criteria

Inclusion Criteria:

• Based on medical history, evidence of TG ≥ 150 mg/dL but ≤ 499 mg/dL on more than one occasion

• Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable optimal statin therapy

• Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 14 days apart

• Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care

• Women of childbearing potential on must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception

• Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1

• Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

• Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or antisense oligonucleotide molecule

• Active pancreatitis within 12 weeks prior to Day 1

• 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 Day 1

• Major surgery within 12 weeks of Day 1

• Planned coronary intervention (e.g., stent placement or heart bypass) during 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 Day 1

• History of bleeding diathesis or coagulopathy

• Current diagnosis of nephrotic syndrome

• Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study

• 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