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Study of ARO-ANG3 in Adults With Mixed Dyslipidemia (ARCHES-2)

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ClinicalTrials.gov Identifier: NCT04832971
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : December 28, 2021
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Mixed Dyslipidemia Drug: ARO-ANG3 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-ANG3 in Adults With Mixed Dyslipidemia
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : April 30, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: ARO-ANG3
ARO-ANG3 Injection
 Drug: ARO-ANG3
2 doses of ARO-ANG3 by subcutaneous (sc) injection
Placebo Comparator: Placebo
Sterile Normal Saline (0.9% NaCl)
 Drug: Placebo
calculated volume to match active treatment by sc injection


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24 [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures :
  1. Percent Change from Baseline in Fasting TG Over Time [ Time Frame: Baseline, up to Week 36 ]
  2. Percent Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 [ Time Frame: Baseline, Week 24 ]
  3. Percent Change from Baseline in Fasting Non-HDL-C Over Time [ Time Frame: Baseline, up to Week 36 ]
  4. Percent Change from Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24 [ Time Frame: Baseline, Week 24 ]
  5. Percent Change from Baseline in Fasting Total ApoB Over Time [ Time Frame: Baseline, up to Week 36 ]
  6. Percent Change from Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation at Week 24 [ Time Frame: Baseline, Week 24 ]
  7. Percent Change from Baseline in Fasting LDL-C Using Ultracentrifugation Over Time [ Time Frame: Baseline, up to Week 36 ]
  8. Percent Change from Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24 [ Time Frame: Baseline, Week 24 ]
  9. Percent Change from Baseline in ANGPTL3 Over Time [ Time Frame: Baseline, up to Week 36 ]
  10. Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24 [ Time Frame: Baseline, Week 24 ]
  11. Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time [ Time Frame: Baseline, up to Week 36 ]
  12. Change from Baseline in Plasma Concentrations of ARO-ANG3 Over Time [ Time Frame: Baseline, up to Week 12 ]
  13. Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Week 24 [ Time Frame: Week 24 ]
  14. Number of Participants with AEs and/or SAEs Through Week 36 [ Time Frame: up to Week 36 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04832971


Contacts
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Contact: Medical Monitor 626-304-3400 AROANG3@arrowheadpharma.com

Locations
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Sponsors and Collaborators
Arrowhead Pharmaceuticals
More Information
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Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04832971    
Other Study ID Numbers: AROANG3-2001
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: December 28, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases