Study of ARO-ANG3 in Adults With Mixed Dyslipidemia
- Registration Number
- NCT04832971
- Lead Sponsor
- Arrowhead Pharmaceuticals
- Brief Summary
The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will initially receive 2 subcutaneous injections of ARO-ANG3 or placebo. Participants who complete the double-blind treatment period may opt to continue in an open-label extension during which they will receive up to 8 doses of ARO-ANG3.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
- Based on medical history, evidence of TG ≥ 150 mg/dL but ≤ 499 mg/dL
- Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable diet and 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 17 days apart
- Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care
- Participants of childbearing potential must agree to use highly-effective contraception during the study and for at least 24 weeks from last dose of study medication
- Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding
- Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1
- Men must not donate sperm during the study and for at least 24 weeks following the last dose of study medication
- Able and willing to provide written informed consent and to comply with study requirements
- 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 or planned surgery during the study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARO-ANG3 100 mg ARO-ANG3 Two doses of ARO-ANG3 bysc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period. ARO-ANG3 200 mg ARO-ANG3 Two doses of ARO-ANG3 by sc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period. Placebo ARO-ANG3 Calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period. Placebo Placebo Calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period. ARO-ANG3 50 mg ARO-ANG3 Two doses of ARO-ANG3 by subcutaneous (sc) injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Fasting TG at Week 24 Baseline, Week 24
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24 Baseline, Week 24 Number of Participants With Treatment Emergent Adverse Events (TEAEs) and/or Serious TEAEs up to Week 24 From first dose of IP up to Week 24 TEAEs are adverse events (AEs) that occur following IP administration or a pre-existing condition exacerbated following IP administration. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.
Number of Participants With AEs and/or SAEs Over Time in the Double-Blind Treatment Period up to Week 36 (double-blind treatment period) Percent Change From Baseline in Fasting TG Over Time Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) Percent Change From Baseline in ANGPTL3 Over Time Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) Percent Change From Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 Baseline, Week 24 Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24 Baseline, Week 24 Plasma Concentrations of ARO-ANG3 Over Time Baseline, up to Week 12 (double-blind treatment period), up to Month 24 (open-label extension) Percent Change From Baseline in Fasting Non-HDL-C Over Time Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24 Baseline, Week 24 Percent Change From Baseline in Fasting Total ApoB Over Time Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) Percent Change From Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation at Week 24 Baseline, Week 24 Percent Change From Baseline in Fasting HDL-C Over Time Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension up to Month 24 (open-label extension)
Trial Locations
- Locations (24)
Baylor College of Medicine
🇺🇸Houston, Texas, United States
AGA Clinical Trials
🇺🇸Hialeah, Florida, United States
Medication Management LLC
🇺🇸Greensboro, North Carolina, United States
Marion Area Health Center
🇺🇸Marion, Ohio, United States
Paratus Clinical Research
🇦🇺Blacktown, New South Wales, Australia
NZCR OpCo Ltd.
🇳🇿Christchurch, New Zealand
University of the Sunshine Coast Clinical Trials Centre
🇦🇺Sippy Downs, Queensland, Australia
Linear Clinical Research
🇦🇺Nedlands, Australia
Recherche Clinique Sigma Inc
🇨🇦Québec, Canada
Ctr de Recherche Clin de Laval
🇨🇦Québec, Canada
Lakeland Clinical Trials - Rotorua
🇳🇿Rotorua, New Zealand
Clinical Research of South Nevada
🇺🇸Las Vegas, Nevada, United States
Methodist Physicians Clinic Heart Consultants
🇺🇸Omaha, Nebraska, United States
Velocity Clinical Research
🇺🇸Huntington Park, California, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Global Research Solutions
🇺🇸Miami, Florida, United States
Icahn School of Medicine at Mount Sinai (ISMMS)
🇺🇸New York, New York, United States
Lucas Research, Inc.
🇺🇸Morehead City, North Carolina, United States
Capital Area Research, LLC
🇺🇸Camp Hill, Pennsylvania, United States
Centre d'Etudes Cliniques
🇨🇦Chicoutimi, Quebec, Canada
Lawson Health Research Institute
🇨🇦London, Ontario, Canada
Lakeland Clinical Trials - Waitemata
🇳🇿Birkenhead, New Zealand
Lakeland Clinical Trials - Waikato
🇳🇿Hamilton, New Zealand
Progressive Medical Research
🇺🇸Port Orange, Florida, United States